REPORT OF THE JOINT MONITORING MISSION REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME
November 2019
#TBHaregaDeshJeetega
Central TB Division, New Delhi
REPORT OF THE JOINT MONITORING MISSION REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME
November 2019 The 2019 Joint Monitoring Mission (JMM) for the Revised National Tuberculosis Control Programme (RNTCP), India was jointly organized by the World Health Organization (WHO) Country Ofce (WCO) for India and the Central Tuberculosis Division (CTD) and led by Dr. Kenneth Castro. The TB mini-epidemiology review conducted just ahead of the JMM was led by Dr. Patrick Moonan. At the conclusion of the JMM eld visits and thematic team deliberations, team leads presented respective executive summaries with top-line recommendations to senior ofcials from Ministry of Health and Family Welfare (MoHFW), Government of India, including Mr. Sanjeeva Kumar, Dr. Arun Kumar Panda, Ms. Vandana Gurnani, Mr. Vikas Sheel, Dr. KS Sachdeva; senior ofcials from WHO including Dr. Soumya Swaminathan, Dr. Tereza Kasaeva, Dr. Henk Bekedam; and a wider international, national and state audience. The MoHFW ofcials shared their reections and commitments for action while the WHO ofcials followed by representatives from Global Coalition of TB Activists, Stop TB Partnership, Medecins Sans Frontieres, and Alliance India also shared their reections and expressed their continued commitment to support India in ending TB by 2025. The JMM (TB), India 2019 report was prepared by a writing group led by Kenneth Castro, with contributions from the thematic and state team leads (alphabetically) – Amy Piatek, Anand Date, Annabel Baddeley, Anuj Bhatnagar, Anurag Bhargava, Avinash Kanchar, A Venkatraman, Blessina Kumar, Daksha Shah, Dawran Faizan, DCS Reddy, Diana Weil, Douglas Fraser Wares, Erika Vitek, Kirankumar Rade, Lal Sadasivan S, L S Chauhan, Malik Parmar, Manoj Jain, Marion Grossmann, Miruna Mosincat, Mohammed Yasin, Mukta Sharma, Nevin Wilson, Patrick Moonan, Puneet Dewan, Rajendra Prasad, Rajesh Solanki, Ranjani Ramachandran, Rebecca Gupta Lawrence, Richard Cunliffe, Rohit Sarin, Ronald Mutasa, Rupak Singla, Sangeeta Sharma, Senait Kebede, SK Sharma, Sreenivas A Nair, Suvanand Sahu, Thomas M Shinnick, Urvashi Singh, Varinder Singh, Vineet Chadha, William Wells, Wilson Lo and Yamuna Mundade. Overall planning, organization, technical assistance, report compilation and coordination was led by the WCO for India (TB team) – Ranjani Ramachandran, Kirankumar Rade and Malik Parmar.
Report of the Joint Monitoring Mission: Revised National Tuberculosis Control Programme, November 2019 ISBN: 978-92-9022-775-5 © World Health Organization 2020 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specic organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Report of the Joint Monitoring Mission: Revised National Tuberculosis Control Programme, November 2019. New Delhi: World Health Organization, Country Ofce for India; 2020. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, gures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specic companies or of certain manufacturers' products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Printed in India Contents
Acknowledgements I Acronyms II Executive Summary 1 1. Introduction 5 1.1 Objectives 5 1.2 Methodology 6 1.3 Background: Epidemiology, Surveillance, Supervision, Monitoring and Evaluation 7 2. Findings and Recommendations 20 2.1 Build 20 2.1.1 Partnerships and Private Provider Engagement 20 2.1.2 Multisectoral Engagement and Accountability 29 2.1.3 Health System Strengthening 32 2.1.4 Tuberculosis in Urban Populations 38 2.1.5 Patient Support Systems 41 2.1.6 Community Engagement, Advocacy, Communication, and Social Mobilization 45 2.1.7 Research and Innovation 48 2.1.8 Technical Assistance to End Tuberculosis in India 55 2.2 Prevent 56 2.2.1 Preventive Services 56 2.3 Detect 62 2.3.1 Case Finding, Diagnostics and Laboratory Services 62 2.4 Treat 69 2.4.1 Treatment Services for Drug Sensitive Tuberculosis 69 2.4.2 Programmatic Management of Drug-resistant Tuberculosis 73 2.4.3 Commodities and Childhood Tuberculosis 82 2.4.3a Childhood TB 89 Annexes 95 3.1 State Level Reports 95 3.1.1 Assam 95 3.1.2 Chhattisgarh 103 3.1.3 Kerala 113 3.1.4 Rajasthan 125 3.1.5 Tamil Nadu 132 3.1.6 Uttar Pradesh 146 3.2 List of Participants 161 3.2.1 Thematic Groups 161 3.2.2 Field Visit Teams 168 Acknowledgements
The 2019 Joint Monitoring Mission (JMM) level tuberculosis (TB) cells, in the six states would not have been possible without the visited (Assam, Chhattisgarh, Kerala, tireless efforts of various members of the now Rajasthan, Tamil Nadu, Uttar Pradesh) National TB Elimination Program (Revised welcomed the members of JMM with National Tuberculosis Control Program meticulous schedules and opportunities for (RNTCP) at the time of JMM), Ministry of eld visits to enable JMM participants to gain Health and Family Welfare (MoHFW), an understanding of the successes, Government of India (GoI), the World Health challenges, and ongoing efforts of the Organization Country Ofce (WCO) for respective TB program activities. Members of India, and multiple other stakeholders. this JMM extend their collective gratitude to all Months of careful planning and multisectoral the participating state and district level TB coordination were required to ensure the programs, WCO, and RNTCP/MoHFW/GoI successful implementation of this JMM. The for their painstaking preparation and RNTCP, along with the state level and district hospitality.
I
Acronyms
AB-PMJAY Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana ACSM Advocacy, Communication, and Social Mobilization ACF Active Case Finding ADR Adverse Drug Reaction ADSM Active Drug Safety Monitoring and Management AE Adverse Events AFB Acid-fast bacillus AI Articial Intelligence AIC Airborne Infection Control Am Amikacin AMC Annual Maintenance Contract ART Antiretroviral Therapy ARTI Annual Rate of TB Infection ASHA Accredited Social Health Activist ATT Anti-tubercular Treatment AYUSH Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa and Homoeopathy BCG Bacille Calmette-Guerin vaccine BDQ Bedaquiline BDQ-CAP Bedaquiline Conditional Access Programme BK+ Bacille de Koch (or Koch bacillus) positive smear BMI Body Mass Index BRICS Brazil, Russia, India, China, and South Africa CB-NAAT Cartridge-based Nucleic Acid Amplication Test CBO Community-based Organization CDS Clinical Decision Support CDST Culture and Drug Sensitivity Testing CFZ Clofazimine
II CHC Community Health Center CME Continuing Medical Education CMSS Central Medical Services Society CPT Cotrimoxazole Preventive Therapy Cs Cycloserine CSO Civil Society Organization CSR Corporate Social Responsibility CTD Central Tuberculosis Division CXR Chest X-Ray DBT Direct Benet Transfer DDS District Drug Stores DLM Delamanid DM Diabetes mellitus DMC Designated Microscopy Center DoP Department of Post DOT Directly Observed Therapy DOTS Directly Observed Therapy, Short-course DR-TB Drug Resistant Tuberculosis DRS Drug Resistance Surveillance DST Drug Susceptibility Testing DS-TB Drug-Sensitive Tuberculosis DTC District Tuberculosis Center DTO District Tuberculosis Ofcer E Ethambutol EPTB Extrapulmonary Tuberculosis Eto Ethionamide EQA External Quality Assurance FDC Fixed-dose Combination FIND Foundation for Innovative New Diagnostics FLD First-line Drugs
III FQ Fluoroquinolone FY Fiscal Year GoI Government of India GDF Global Drug Facility GeneXpert Xpert MTB/RIF cartridge-based nucleic acid amplication test to detect M. tuberculosis and rifampin resistance GF (or Global Fund) Global Fund Against HIV/AIDS, Tuberculosis, and Malaria H Isoniazid Hh Isoniazid High Dose HD High Dose HR Human Resources HS Health Systems HSS Health Systems Strengthening IC Infection Control ICF Intensied Case Finding ICMR Indian Council of Medical Research ICT Information and Communication Technologies ICTC Integrated Counseling and Testing Center IDAT Integrated Digital Adherence Technologies IEC Information, Education, and Communication IGRA Interferon-Gamma Release Assay IHME Institute for Health Metrics and Evaluation IMA Indian Medical Association IP Implementing Partner IRL Intermediate Reference Laboratory ITRC India Tuberculosis Research Consortium IVA Independent Verication Agency JEET Joint Effort for Elimination of Tuberculosis JMM Joint Monitoring Mission Km Kanamycin
IV KPI Key Performance Indicator LF-LAM Lateral Flow Urine Lipoarabinomannan Assay Lfx Levooxacin LIMS Laboratory Information Management System LPA Line-probe Assay LT Laboratory Technician LTBI Latent Tuberculosis Infection LZD Linezolid M&E Monitoring and Evaluation MAF-TB Multisectoral Accountability Framework for Tuberculosis MCH Maternal and Child Health MDG Millennium Development Goal MDR Multidrug Resistance MDR-TB Multidrug Resistant Tuberculosis MERMs Medication Event Reminder Monitors Mfx Moxioxacin MoHRD Ministry of Human Resource Development MoHUPA Ministry of Housing & Urban Poverty Alleviation MO Medical Ofcer MoD Ministry of Defence MoHFW Ministry of Health and Family Welfare MOTC Medical Ofcer Tuberculosis Control MOU Memorandum of Understanding MoUD Ministry of Urban Development MPHW Multipurpose Health Worker MoWCD Ministry of Women & Child Development NAAT Nucleic Acid Amplication Tests NACO National AIDS Control Organization NACP National AIDS Control Program NCD Noncommunicable Disease
V NDRS National Anti-Tuberculosis Drug Resistance Survey NGO Non-governmental Organization NGS Next-Generation Sequencing NHA National Health Authority NHM National Health Mission NIKSHAY Web-enabled electronic TB case notication/ monitoring system NIRT National Institute for Research in Tuberculosis NITRD National Institute of Tuberculosis and Respiratory Diseases NPCDCS National Programme for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases, and Stroke NPY NIKSHAY Poshan Yojana (nutritional support to TB patients) NRHM National Rural Health Mission NRL National Reference Laboratory NSP National Strategic Plan NSS National Sample Survey NTCP National Tobacco Control Programme NTI National Tuberculosis Institute NTSU National Technical Support Unit NUHM National Urban Health Mission NVHCP National Viral Hepatitis Control Program OOP Out-of-pocket expenditures OpASHA Operation ASHA OR Operational Research OSE On-Site Evaluation OTC Over-the-counter drugs Pa Pretomanid PDS Public Distribution System PFMS Public Financial Management System PHC Primary Health Center PHI Peripheral Health Institution
VI PIP Project Implementation Plan PLHIV People Living with HIV/AIDS PMDT Programmatic Management of Drug Resistant Tuberculosis PP Private Practitioner PPE Private Provider Engagement PPM Public-Private Mix PPSA Patient Provider Support Agency PR Principal Recipient of grant from the Global Fund Against HIV/AIDS, Tuberculosis and Malaria PRI Panchayati Raj Institution PSM Procurement and Supply Management PTB Pulmonary Tuberculosis PVPI Pharmacovigilance Programme of India QA Quality Assurance R Rifampicin RBSK Rashtriya Bal Swasthya Karyakram (initiative for early child screening and intervention services) RBRC Random Blinded Re-checking RCT Randomized Controlled Trial RCH Reproductive and Child Health RNTCP Revised National Tuberculosis Control Program RR-TB Rifampicin-Resistant Tuberculosis SDS State Drug Stores SHG Self-help Group SLD Second-line Drugs SL-DST Second-line Drug Susceptibility Testing SLI Second-line Injectable Drugs STC State Tuberculosis Cell STCI Standards for Tuberculosis Care in India STDC State Tuberculosis Training and Demonstration Center STR Shorter Treatment Regimen for drug-resistant TB
VII STLS State Tuberculosis Laboratory Supervisor STO State Tuberculosis Ofcer STS Senior Treatment Supervisor TA Technical Assistance TAT Turnaround Times TB Tuberculosis TBHV Tuberculosis Health Visitor TOG Technical and Operational Guidelines TOR Terms of Reference TueNat MTB Chip-based nucleic acid amplication test to detect M.tuberculosis TrueNat MTB-RIF Dx Chip-based nucleic acid amplication test to detect rifampicin- resistant M. tuberculosis TSG Technical Support Group TST Tuberculin Skin Test TSU Technical Support Unit TU Tuberculosis Unit UATBC Universal Access to Tuberculosis Care UDST Universal Drug Susceptibility Tests UHC Universal Health Coverage UN United Nations UNAIDS Joint United Nations Programme on HIV/AIDS UNHLM United Nations High-level Meeting USAID United States Agency for International Development UVGI Ultraviolet Germicidal Irradiation WCO World Health Organization Country Ofce WHO World Health Organization WHP World Health Partners XDR-TB Extensively Drug Resistant Tuberculosis YLL Years of Life Lost Z Pyrazinamide
VIII
Executive Summary
This is the seventh World Health Organization approaches, remarkably reaching 1 million in the (WHO) - Government of India (GoI) Joint private sector over the past two years. In addition, Monitoring Mission (JMM) on tuberculosis (TB) RNTCP has responded to the dangerous problem since the launch of the Revised National TB Control of drug-resistant TB, and is making progress Program (RNTCP) in India 21 years ago. Members towards offering universal drug susceptibility of the 2019 JMM applaud India's commitment to testing for people diagnosed with TB, employing end TB by 2025, and the National Strategic Plan for 1530 rapid molecular diagnostic devices (NAAT), Tuberculosis 2017-25: Elimination by 2025 (NSP). testing 1 million people with TB, and ultimately detecting and treating 58,347 TB patients with In 2017 the Honorable Prime Minister Narenda multidrug or rifampicin resistant forms of TB in Modi enthusiastically endorsed the implementation 2018. Enabling these expansions reects a new of India's NSP, which has been underway since then. commitment to patient-centered services and care, Prime Minister Modi has repeatedly committed to emphasizing community engagement and the nation and the world to reach the 2030 United mobilizing the general health system in the national Nations (UN) Sustainable Development Goals effort against TB. (SDG) Target to End the TB Epidemic by 20251 . Furthermore, India committed at the 2018 UN Despite these accomplishments, the challenges High-Level Meeting on ending TB, which is critical ahead remain daunting and are accompanied by a to ending the epidemic globally. Unprecedented risk of failure to achieve the national goals unless political commitment to address TB has been concrete and deliberate actions are promptly summoned, from the Central Government through undertaken. Nearly 0.5 million people with TB States and Districts. Domestic investment in TB has disease remain missing to TB surveillance/ nearly quadrupled since the last JMM in 2015.This notication and services, and are likely in private response is commensurate with the nation's severe health delivery systems or the community. Those and disproportionate burden of TB. Further, who are found experience attrition through the acceleration of global progress against TB and cascade of care; hundreds of thousands are lost MDR-TB is being led by India, as recognized in the along their journey through diagnosis and WHO's Global TB Report 2019. treatment, particularly among those reported by private providers. Furthermore, many patients Tangible achievements include an additional reported by private providers could not be 700,000 people with TB disease detected in the conrmed to have completed treatment. Many are past two years and notied through the upgraded not routinely screened or treated for drug NIKSHAY national digital information system. resistance and key comorbidities such as HIV, RNTCP leveraged near-universal mobile network diabetes, or malnutrition – all critical measures to access and India's digital payments infrastructure to maximize successful treatment outcomes and deploy social support via accountable electronic survival. direct benets transfer (DBT), which has been expanded for all TB patients. RNTCP also learned Scale-up of services has been slowed by limited how to effectively engage private providers, who supplies of drugs and diagnostics to meet the account for most healthcare delivery services, and rapidly expanding demand. JMM visitors received is scaling up these and other innovative anecdotal reports of drug stock-outs; these were
1The End TB Strategy targets, in line with the SDG target for ending TB are by 2030 (relative to 2015), to achieve an 80% reduction in TB incidence, a 90 reduction in TB mortality, and eliminating catastrophic costs for patients and affected households.
1 not independently veried. Existing vacancies in procurement or innovative contracting for allocated RNTCP staff positions in many states also drugs and diagnostics to meet rapidly limit progress. The power of India's general health expanding demand. And consider renaming system has not been harnessed for the national the RNTCP as the National TB Elimination campaign against TB, particularly in settings with Program (NTEP) to explicitly reect this the highest burden of disease. Tools available to ambitious campaign. Translating these and RNTCP, such as advanced molecular diagnostics, other recommendations into action will enhanced patient and adherence support systems, require adequate nancing for TB. An or newer drug regimens, still remain incompletely ambitious budget for the next 5 years is implemented. required, and the Government of India should increase the level of nancing for TB Underdiagnosis of paediatric TB remains a based on robust estimates and work plans challenge. The most pressing challenges include for the 2020-25 period, making sure that the limited capacity for case detection, lack of sensitive most innovative aspects of the NSP are diagnostics and inconsistent availability of child adequately funded based on proper budget friendly anti-TB drug formulations for prevention forecasts. These plans must drive multi- and cure. sectoral action and accountability, based on the Right to Health, under the stewardship of To overcome these identied challenges, the a National TB Elimination Board, with State “mission mode” envisioned in the NSP must be counterparts backed by legislation. And enacted. A national movement to address TB, rapidly develop, implement, monitor and encompassing patients, civil society, communities rigorously review TB Elimination plans for and TB survivors, has yet to become fully every State, and consider convening the implemented. The current trajectory, while eight mega-cities for a focused effort specic markedly improved over ndings of past JMMs, to these areas and commensurate with their will fall far short of achieving the Prime Minister's high burden. Also act so that vulnerable and commitment to end the TB epidemic by 2025. marginalized populations are served with urgency. India can only succeed if local The members of this 2019 JMM clearly and government, communities, and civil society unequivocally support India's ambitions, and are mobilized to detect and support every acknowledge that success will require a redoubling person suffering from TB and every affected of effort and investment, marshalling the entire family. health system, investing in terms of both people and money, and deploying new approaches to 2. Provide urgent reinforcements to the rapidly interrupt person-to-person transmission of existing workforce of dedicated and skilled TB and save countless lives. workers with additional trained persons to tackle the increased workload. Immediately To approach the Prime Minister's commitment to hire pending vacancies at all levels of local, reach the NSP targets by 2025, the Mission state and national level. Deploy human recommends the following ten actions: resources and outsource selected functions to properly address the unprecedented 1. Mount the TB elimination campaign expansion of early TB case nding, up-to-date envisaged in India's NSP with clear and quality-assured diagnostic laboratory accountability and multisectoral services, expansion of newer approved engagement – inspired by lessons gained treatment regimens, new prevention activities, from Polio eradication in India. This TB management of private sector models, DBT elimination campaign must incorporate schemes. Also, develop and execute a multi- aggressive forecasting, and direct year national and state human resource plan
2 that informs the targeted addition of trained technical assistance to help address emerging and dedicated staff “t for purpose” by relying priorities, build communities of practice, use on in-person and digital training platforms, local data for local action, and rapidly using principles of quality improvement to respond to outbreaks. strengthen cascades of care, and outsourcing support for capacity development. 6. Deploy new precision diagnostic tools and ensure access to prompt, quality-assured 3. Rapidly scale-up private provider testing for accelerated progress, and scale- engagement, by collaborating with qualied up advanced diagnostics services and TB allopathic providers and AYUSH providers to surveillance capacity. Displace insensitive nd and successfully treat 2 million patients in sputum smear microscopy with molecular TB 2020-2021. Leverage the newly released diagnosis fully decentralized nationwide, Guidance for Partnerships and technical alongside outsourcing to India's enormous support units for output-based contracting of private laboratory capacity, for 20 million the workforce and services required to reach advanced molecular diagnostic tests annually. and provide quality services to double the Provide rapid drug susceptibility testing to all number of TB patients being treated today. eligible persons diagnosed with TB disease -- Make use of conscious change management adult and pediatric, public and private. as the government undertakes the new ways of working inherent to output-based 7. Support patients comprehensively contracting, and consider using public funds throughout treatment, using a people- to purchase privately supplied quality-assured centered approach. Enable people drugs and diagnostics. Embed and implement identied with TB disease to initiate, and reimbursement packages for outpatient TB sustain themselves on patient-friendly services and for secondary and tertiary care treatment regimens, including via budgeted provided under Pradhan Mantri Jan Arogya support for patient peer groups, and eliminate Yojana (PMJAY). the social and economic impacts of disease. Supplement staff, and community support and 4. Move from passive community engagement use of digital tools. Strengthen the DBT system to full community participation and and nutritional/ social support ownership, with reliance on TB champions implementation for differentiated care and TB Survivors working alongside according to need and context, to reach all TB programme staff in advocacy, planning, patients and secure nutritional gains and end implementation and monitoring of the local, catastrophic costs. Provide access to the latest state, and national TB response. Invest in local evidence-based and recommended drug TB forums which are effective change agents regimens for improved treatment and able to work at reducing/eliminating stigma outcomes of people with drug-resistant forms and a human rights response framework. of TB.
5. Invest in TB surveillance staff and systems for 8. Re-design and pursue targeted active case accurate, complete, and timely information nding efforts, learning from experiences to that ensures the collection and analysis of better screen epidemiologically-dened key high-quality, effective service delivery, affected populations and close contacts of performance monitoring, and understands people with TB disease. Emphasize the the drivers of TB transmission. A network of proven roles of digital chest x-ray screening national-, state-, and district-level TB and rapid molecular diagnostic tests. Surveillance Units should be established by 2020. Augment the surveillance network with 9. Deploy and evaluate ambitious plans to
3 implement TB preventive treatment of novel specic skin tests (e.g. C-TB) for household and other close contacts, children, diagnosing latent TB, automated digital chest PLHIV and other locally-dened high-risk x-ray interpretation, and new groups, using new, shorter regimens drugs/regimens, and based on the latest (reaching an expected 6 million eligible evidence-based global guidance. Expand persons annually by 2021). research investments with urgency against these national and global needs. 10. Invest in research to develop additional new tools required to end TB and in the rapid The members of the 2019 JMM agree that the uptake of available new tools, products – such recommendations above represent the minimum as simple triage/screening, use of non- required to fulll the Prime Minister's national and sputum clinical specimens for accurate global commitment and reach End TB in India by bacteriologic diagnosis of extrapulmonary 2025. These recommendations are largely in line and paediatric TB, and simpler/safer/shorter with India's NSP, and a new expanded budget is universal curative TB treatment regimens. required commensurate with the historically Immediately scale-up available tools, such as unprecedented national ambition.
4 1. Introduction
The previous World Health Organization (WHO) - forthcoming, but some relevant information Government of India (GoI) Joint Monitoring collected during that review has been incorporated Mission (JMM) was conducted in 2015; much has into this report. Lastly, the report contains annexes changed in India’s tuberculosis (TB) landscape with other relevant information, such as the six state since then. Several recommendations provided by reports and participant list. that 2015 JMM and follow-up work during National Consultative Meetings in Delhi (October 1.1 Objectives 2016 and March, April 2017) supported the The main goal of this JMM is to review the progress, development of India’s National Strategic Plan for challenges, and plans for India’s TB control efforts Tuberculosis 2017-25: Elimination by 2025 (NSP). in the setting of the NSP 2017-2025, and to advise This NSP was launched in 2017 with the full GoI, WHO, and partners on the pathway towards endorsement by India’s Prime Minister Narendra achieving Universal Access to TB care. To achieve Modi, who subsequently reinforced the country’s this, the JMM participants were asked to focus on commitment to ending TB in India by 2025 (ve the following key objectives and terms of reference, years ahead of the Sustainable Development Goals and to assess: of 2030) during the rst ever United Nations High- Level Meeting (UNHLM) on ending TB, held in New 1. Mid-term progress of the NSP and York September 2018. This ambitious declaration recommendations for course corrections. and unprecedented political support served as the 2. Current performance and sustainability of the background context for the 2019 WHO-GoI JMM. Programme and development of In order to conduct a successful JMM with clear, recommendations for future activities actionable recommendations for the GoI, specic 3. The TB surveillance system, monitoring & objectives and a sound methodology were evaluation strategy and analysis of the required. The WHO-GoI JMM is one of the largest epidemiological data including digital JMMs in the world with a diverse set of initiatives multidisciplinary expert participants. 4. Diagnostics of TB and multidrug resistant TB This nal report, including the format in which it is (MDR-TB) in the country and the operation of presented, is a direct result of discussions among the laboratory network. members of the JMM. Participants were provided 5. Implementation of basic TB services and with terms of reference to review twelve distinct programmatic management of drug resistant thematic areas. During thematic discussions, it was TB (PDMT). agreed that the report’s thematic ndings and 6. Partnership strategies and progress within and recommendations should be grouped under the outside of the health sector for ending TB in four pillars of India’s NSP (Build, Prevent, Detect, India. Treat). As such, this report is structured to present the objectives and methodology used for this JMM, 7. Assessment of research priorities and its followed by observations, ndings, and progress. recommendations for each thematic area clustered 8. The collaborative framework for TB into the aforementioned pillars. In addition, this comorbidities, its implementation, gaps JMM was preceded by an abridged analysis and recommendations thereof. Epidemiological Review of TB in India. A separate 9. Childhood TB, including drug resistant TB (DR- report of that Epidemiological review is TB) diagnosis and management.
5 10. The diagnostics and anti-TB drug procurement programmatic performance. and supply chain management. WHO and GoI organizers of this 2019 JMM 11. Current engagement with civil society identied and designated specic leaders for organizations (CSOs) and patient groups, and Thematic, State, and District Teams. Following an the extent to which their potential contribution introductory rst-day orientation and review of the to the detection, treatment and care of terms of reference, all JMM participants traveled to individuals with TB has been maximized. spend the rst week of the review observing TB 12. Progress on implementation of multisectoral program activities by conducting eld visits and accountability framework (MAF-TB) and meetings with relevant stakeholders in the 11 addressing determinants of health. designated districts from six states. During the second week, JMM participants reconvened in New 13. Social protection and nutritional support. Delhi to develop and articulate observations, 14. Strategies and progress for management of ndings, and recommendations across the various latent TB infection among people living with teams. Full review participants were engaged in HIV/AIDS (PLHIV) and children in India. the JMM for the entirety of the two-week review, 15. Human resources (HR) and development, health while additional participants joined later to system strengthening (HSS) and programme participate in thematic discussions and report nancing. writing. 16. Technical assistance (TA) requirements for the Figure 1: In the map above, the states and programme to facilitate ending TB in India. districts highlighted in light and dark blue, respectively, were visited by the JMM team. 17. Identify and present specic recommendations regarding the actions and priorities for ending TB in the country as per the set target of 2025.
1.2 Methodology The WHO-GoI JMM conducted a two-week intensive review of the TB program in India during November 11th to 22nd, 2019. As one of the largest JMMs in the world, this JMM welcomed 165 multidisciplinary professionals (32 international and 133 national experts), including representatives from WHO, technical agencies, development agencies, national institutes, medical colleges, and civil society. These distinguished participants were carefully divided into teams to ensure, as much as possible, distribution of different areas of technical expertise among each of the eld groups. Six state teams (Assam, Chhattisgarh, Kerala, Rajasthan, Tamil Nadu, and Uttar Pradesh) were created, and further subdivided During scheduled site visits and meetings with into eleven district teams (Figure 1). The sites to be relevant district and state level stakeholders, teams visited were jointly pre-selected by WHO Country were directed to focus their observations on twelve Ofce (WCO) and RNTCP/MoHFW, taking into specic thematic areas: (1) Epidemiology, consideration different criteria, such as diversity in Surveillance, Supervision, Monitoring & Evaluation; burden of disease, urban and rural settings, (2) Preventative Services; (3) Case Finding, geographic dispersion, and range of perceived Diagnostics & Laboratory Services; (4) Treatment
6 Services for Drug Sensitive TB; (5) Programmatic Following the summary of key recommendations, Management of Drug Resistant Tuberculosis; (6) the designated leads for Thematic, State, and Comorbidities & Childhood TB; (7) Multi-sectoral District Teams submitted draft written reports to Engagement & Patient Support Systems; (8) cover each of these designated areas. These reports Partnerships and Urban TB; (9) Community were consolidated and edited by JMM participant Engagement, Advocacy and Communication; (10) (M Monsicat), then further reviewed and edited by Health Systems Strengthening; (11) Technical JMM Lead (KG Castro), and submitted to WHO Assistance to End TB in India; (12) Research & Leads (M Parmar, R Ramachandran, and K Rade) Innovation. and RNTCP Deputy Director General-TB (KS Sachdeva). When the JMM participants reconvened in New Delhi, the state teams consolidated their ndings 1.3 Background: Epidemiology, and presented these to all JMM participants to elicit Surveillance, Supervision, Monitoring feedback and incorporate additional comments (see Appendix 1 for State Reports). Next, the and Evaluation participants split into teams across the twelve After decades of successful program thematic areas; these thematic teams worked to implementation, India has accomplished develop consensus on the main observations, numerous impressive achievements in tuberculosis ndings, and technical recommendations. During prevention, care and control. Since its inception, the thematic team discussions, it was decided to further RNTCP has contributed to screening more than 80 group the twelve themes under the four pillars of the million people for tuberculosis, successfully treated NSP (Detect, Treat, Prevent, Build); thematic groups 15 million patients and saved millions of lives.2 met in the four pillar groups to further combine and However, India continues to bear the largest later present ndings and recommendations for number of TB patients, and TB-related deaths in the added feedback from all JMM participants. Finally, world.3 The epidemiology of tuberculosis in India is an executive summary was created from the state, heterogeneous, both from an epidemiological thematic, and pillar presentations. This summary perspective and in terms of programmatic of key ndings and recommendations was performance.4 Results from subnational TB presented on the nal day of the JMM to high-level prevalence surveys5,6,7,8,9,10,11 annual rate of representatives from the Ministry of Health and tuberculosis infection (ARTI) surveys12 and analysis Family Welfare (MoHFW) and WHO. of routinely collected programme
2 Mandal S, Chadha VK, Laxminarayan R, et al. Counting the lives saved by DOTS in India: a model-based approach. BMC Med 2017;15:47. 3 World Health Organization. Global tuberculosis report, 2019. WHO: Geneva, 2019. (WHO/CDS/TB/2019.15). 4Chadha VK. Tuberculosis epidemiology in India: a review. Int J Tuberc Lung Dis. 2005;9:1072–82. 5Aggarwal AN, Gupta D, Agarwal R, et al. Prevalence of pulmonary tuberculosis among adults in a north Indian district. PLoS One. 2015 Feb 19; 10(2):e0117363. 6Chadha VK, Kumar P, Anjinappa SM, et al. Prevalence of pulmonary tuberculosis among adults in a rural sub-district of South India. PLoS One 2012;7:e42625. 7Katoch K, Chauhan DS, Yadav VK, et al. Prevalence survey of bacillary pulmonary tuberculosis in Western Uttar Pradesh, India. J Infect Pulm Dis. 2015;1:1–7. 8Kolappan C, Subramani R, Radhakrishna S, et al. Trends in the prevalence of pulmonary tuberculosis over a Period of seven and half years in a rural community in South India with DOTS. Indian J Tuberc 2013; 60:168–176. 9Narang P, Mendiratta DK, Tyagi NK, et al. Prevalence of pulmonary tuberculosis in Wardha district of Maharashtra, Central India. J Epidemiol Glob Health. 2015:S2210-6006(15)00035-0. 10Rao VG, Bhat J, Yadav R, et al. Prevalence of pulmonary tuberculosis – a baseline survey in central India. PLoS One 2012;7:e43225. 11Sharma SK, Goel A, Gupta SK, Mohan K, Sreenivas V, Rai SK, et al. Prevalence of tuberculosis in Faridabad district, Haryana State, India. Indian J Med Res. 2015;141(2): 228–235. 12Chadha VK, Sarin R, Narang P, et al. Trends in the annual risk of tuberculous infection in India. Int J Tuberc Lung Dis. 2013;17:312–9.
7 surveillance data13,14 reveal substantial local 100,000 persons (95% Condence Limits [95%CL]: variation in prevalence, rates of HIV coinfection, 136–273).17 TB incidence appears to be on the drug-resistant forms of TB, and utilization of TB decline; with a 8.3 percent rate decrease since 2015 services in the private sector. (2015: 217; 95%CL: 112–355).18 These trends appear to be consistent among new, previously As mentioned in the Methods section, an treated and HIV positive patients (Figure 2). abridged epidemiological review of TB in India was conducted in the weeks before the JMM. The It should be noted that current estimates of information that follows is a summary of the full incidence rely on the extent of under-reporting report and is meant to set the context for the (assumed at 40 percent based on expert opinion). observations, ndings, and recommendations However, recent analysis of private drug sales data that follow. suggested that an enormous number of TB patients are seeking treatment in the private sector(1.2–5.3 TB Burden million patients per year).19 While it is unknown how many of the patients studied were over-diagnosed, TB Incidence there are concerns that the true incidence may be In 2018, India notied 2,155,894 patients,15 much higher than has been estimated, despite representing a 23.9 percent increase in total 20 consistent and stable trends in drug sales The notications as compared to 2015.16 The total pending results of the national prevalence survey estimated TB incidence in 2018 was 199 patients per holds promise to recalibrate our assumptions and Figure 2: Trends in annual number of notied calculate more accurate burden estimates. TB patients, estimated TB incidence among new, previously treated (relapse) and HIV positive – TB Prevalence India: 2000–2018. Direct estimates of TB prevalence have not been obtained since the rst nationwide prevalence survey in 1955–1958.21 Current estimates for national TB prevalence are mathematically derived from previously conducted state-based surveys.22 In 2009, national TB prevalence was estimated at 301 per 100,000 population based on annualized adjusted data from sub-national surveys among about 715,989 participants across 10 geographies (Table 1).23 National TB incidence estimates are derived from the prevalence data of the Gujarat survey alone by dividing the prevalence estimate by Source: WHO Global TB Report, 2019.
1 3 Joint Monitoring Mission India. Report of the Joint Monitoring Mission India, 2015. Available from: http://www.tbonline.info/media/uploads/documents/jmmdraft2015.pdf. 14Government of India, Ministry of Health and Family Welfare, Central TB Division. TB India 2017: Revised National Tuberculosis Control Programme Annual Status Report. New Delhi: Government of India, 2018. 15World Health Organization. Global tuberculosis report, 2019. WHO: Geneva, 2019. (WHO/CDS/TB/2019.15). 16World Health Organization. Global tuberculosis report, 2016. WHO: Geneva, 2016. (WHO/HTM/TB/2016.13). 17World Health Organization. Global tuberculosis report, 2019. WHO: Geneva, 2019. (WHO/CDS/TB/2019.15). 18World Health Organization. Global tuberculosis report, 2016. WHO: Geneva, 2016. (WHO/HTM/TB/2016.13). 19Arinaminpathy N, Batra D, Khaparde S, et al. The number of privately treated tuberculosis cases in India: an estimation from drug sales data. Lancet Infect Dis. 2016 Nov;16(11):1255-1260. 20Arinaminpathy N, Batra D, Maheshwari N, et al. Tuberculosis treatment in the private healthcare sector in India: an analysis of recent trends and volumes using drug sales data. BMC Infect Dis. 2019;19(1):539. 21Indian Council of Medical Research. Tuberculosis in India: A National Sample Survey; ICMR Special Report Series No.34, 1955–1958. ICMR: New Delhi, 1959. 22Chadha VK, Anjinappa SM, Dave P, et al. Sub-national TB prevalence surveys in India, 2006–2012: Results of uniformly conducted data analysis. PLoS One. 2019 Feb 22;14(2):e0212264. 23Chadha VK, Anjinappa SM, Dave P, et al. Sub-national TB prevalence surveys in India, 2006–2012: Results of uniformly conducted data analysis. PLoS One. 2019 Feb 22;14(2):e0212264.
8 the estimated duration disease and applying the While a nationwide national prevalence survey has rate of decline in annual ARTI. Thus, in 2018, the begun (September 2019), results from the 500,000 estimated TB incidence was 2.7 million (1.8–3.7 persons, 625 survey sites will take longer to million) patients. This estimate has declined at a complete and nalize. In the interim, a recent steady pace of 2 percent per year since 2015. publication summarized sub-national surveys and Applying the observed decline of 4.5 percent per revealed wide geographic variation and year in annual risk of TB infection, (as the trends in discordance with the corresponding annual ATRI have been observed to be directly related to notication rates (Table 1).24 trends in prevalence), the estimated incidence in 2019 would be about 200 per 100,000 population.
Table 1: Subnational prevalence survey estimates, and prevalence to notication ratio.
Adapted from: Chadha VK, Anjinappa SM, Dave P, et al. 2019
The observed ratio of TB prevalence to TB notication not only improved epidemiological notication rates reported in this study was 4.9:1 surveillance but also extended the range of services (range: 2.3–8.2 to 1).25 These ndings suggested – available to patients from the RNTCP. All registered in addition to the Arinamipathy et al. estimates patients may now access accurate diagnosis, noted above – a substantial proportion of patients effective no-cost treatment, including treatment for remain outside the programme or remain drug-resistant forms of TB, contact tracing undiagnosed and untreated in the community. (screening, testing, treatment as appropriate), and Noteworthy targeted and nationwide efforts have social support systems. Indeed, the proportion of attempted to address this gap. In 2012, the GoI patients notied from the private sector has declared TB as a notiable disease. All public and substantially increased. In 2013, only 2 percent of private health providers are now required to notify all notied patients were from the private sector; all diagnosed and/or treated TB patients to their this proportion has increased to 28 percent in 2019 respective District TB ofcers. Mandatory (Figure 3).
24Chadha VK, Anjinappa SM, Dave P, et al. Sub-national TB prevalence surveys in India, 2006–2012: Results of uniformly conducted data analysis. PLoS One. 2019 Feb 22;14(2):e0212264. 25Chadha VK, Anjinappa SM, Dave P, et al. Sub-national TB prevalence surveys in India, 2006–2012: Results of uniformly conducted data analysis. PLoS One. 2019 Feb 22;14(2):e0212264.
9 Figure 3: Number of notied TB patients from public and private sectors, 2000–2019.
Source: RNTCP Programme Data, 2019. *Signies data through November, 2019
Overall case notication has also improved since the last JMM. A signicant year-after-year case notication increase has been observed since 2015 (Figure 4), including an 18 percent increase in overall notications from 2017 to 2018.
Figure 4: Percent annual notication difference from the preceding reporting year - India 2006-2018
Source: RNTCP Programme Data, 2019.
It remains unclear if the positive trend for increases incidence. Recent models suggest that focus on TB in case notications resulted in more TB contact disease alone has a limited impact on the reduction investigations, more opportunities to prevent in future incidence without the additive effect of TB transmission, or reduced the progression from preventive treatment for people with latent TB infection to disease with impacting overall infection (LTBI).26 Current estimates for the number
26Houben R, Menzies NA, Sumner T, et al. Feasibility of achieving the 2025 WHO global tuberculosis targets in South Africa, China, and India: a combined analysis of 11 mathematical models. Lancet Glob Health. 2016;4:e806–e815.
10 of persons with LTBI in India is substantial.27 infections occur in India every year.28,29,30 Without Assuming a conservative average of four further action and investment, 24 million new household contacts per notied patient and 50 tuberculosis household infections will occur by percent tuberculosis infection rate among them, an 2025 (Table 2).31 estimated 4 million new tuberculosis household
Table 2: Potential burden of latent tuberculosis infection among household members by antituberculosis drug resistance prole, India—2016.
TB Mortality At the global level, India follows the routine As observed in the 2015 JMM report,32 there surveillance and reporting guidelines remains no complete reporting of the accurate recommended by the WHO and considers any causes of death in India. Mortality estimates were death that occurs during TB treatment as a TB- derived jointly under the aegis of Indian Council of related death. Attributing all-cause mortality can Medical Research (ICMR) and Institute for Health overestimate TB case-fatality rates. Thus, mortality Metrics and Evaluation (IHME) using the vital estimates in India rely on a subset of data from registration data. The mortality age-stratied rates mostly urban (but weak) vital registration systems. were rescaled to sum all-cause mortality using a The risk of bias towards underestimation of TB modelling approach that converges with trends with deaths remains high as medical certication is less TB incidence and TB prevalence. Various co- likely in rural areas, and amongst the poor – two variates were used to inform the model. In 2018, populations at greatest risk of TB mortality. In 2018, this analysis estimated 450,000 (including TB less than 15 percent of all deaths in India had a attributable deaths in PLHIV) persons died of TB. TB medically certied cause of death registered with and HIV together account for 5.4 percent of all civil registration; a substantial proportion of deaths in 2018, the percentage contribution being certied deaths were attributed to cardiac or highest in the productive age groups of 15–39 respiratory arrest. Nevertheless, WHO estimated years and 40–69 years at 11.5 percent and 6.9 that 440,000 (95%CL: 408,000–472,000) HIV- 33 percent respectively. negative persons died of TB in 2018. This
27Cohen A, Mathiasen VD, Schön T, Wejse C. The global prevalence of latent tuberculosis: a systematic review and meta-analysis. Eur Respir J. 2019;54(3):1900655. 28Narasimhan P, MacIntyre CR, Mathai D, et al. High rates of latent TB infection in contacts and the wider community in South India. Trans R Soc Trop Med Hyg. 2017;111:55–61. 29Ofce of the Registrar General and Census Commissioner, India, 2018. HH-01. Normal households by household size. Available from: http://www.censusindia.gov.in/2011census/hh-series/hh01.html. 30Khaparde K, Jethani P, Dewan PK, et al. Evaluation of TB Case Finding through Systematic Contact Investigation, Chhattisgarh, India. Tuberc Res Treat. 2015; 670167. 31Moonan PK, Nair SA, Chadha VK, et al. Tuberculosis preventive treatment: the next chapter of tuberculosis elimination in India. BMJ Glob Health. 2018; 3(5):e001135. 3 2 Joint Monitoring Mission India. Report of the Joint Monitoring Mission India, 2015. Available from: http://www.tbonline.info/media/uploads/documents/jmmdraft2015.pdf.
11 translates into an estimated TB mortality rate of 32 prematurely. As an alternative measure of mortality deaths per 100,000 (95%CL: 30,000– 35,000).34 rates, this method gives more weight to deaths that Using the best available data from the Global occur among younger persons. Thus, the Disease Burden Studies conducted in 2013, and interpretation of 14 million YLL relative to 40 deaths 2016, an estimated 545,516 (95%CL: per 100,000, suggests more younger persons are 450,129–650,735) HIV-negative persons die of TB dying of TB than older persons in India. The annually in India;35,36 including an estimated TB annualized case-fatality ratio (i.e. estimated mortality rate of 40 deaths per 100,00 (95%CL: mortality / estimated incidence) is presented in 33–48), 14,000,000 years of life lost (YLL) per Figure 5. The case-fatality ratio has remained year.37 YLL is an estimate of the average years a stable over time. person would have lived if he or she had not died
Figure 5: Annualized case-fatality ratio – India, 2000–2018.
95% condence limits are represented by yellow lines. Source: RNTCP Programme Data, 2019.
33World Health Organization. Global tuberculosis report, 2019. WHO: Geneva, 2019. (WHO/CDS/TB/2019.15). 34World Health Organization. Global tuberculosis report, 2019. WHO: Geneva, 2019. (WHO/CDS/TB/2019.15). 35Murray CJ, Ortblad KF, Guinovart C, et al. Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;384(9947):1005-70. 36Menon GR, Singh L, Sharma P, et al. National Burden Estimates of healthy life lost in India, 2017: an analysis using direct mortality data and indirect disability data. Lancet Glob Health. 2019;7(12):e1675-e1684. 37Menon GR, Singh L, Sharma P, et al. National Burden Estimates of healthy life lost in India, 2017: an analysis using direct mortality data and indirect disability data. Lancet Glob Health. 2019;7(12):e1675-e1684.
12 Presumptive examinations, bacteriologic CB-NAAT with GeneXpert (Xpert MTB/RIF) can conrmation, and HIV testing result in a 7 percent annual reduction in TB incidence, and 12 percent annual reduction in TB Accurate diagnosis is the leading prognostic factor 38 mortality. Since 2012, bacteriologic conrmation for curing TB. Bacteriologic conrmation of TB amongst new and previously treated patients in the disease is essential for starting the most effective public sector has remained relatively stable (Figure treatment course and to monitor clinical outcomes. 6). This is despite the number of presumptive Recent models suggest that improving access to examinations increasing over time with wide accurate diagnosis by simply replacing sputum- geographic variation (Figure 7). smear microscopy with rapid molecular test such as
Figure 6: Bacteriologically conrmed notications amongst new and previously treated patients – India, 2012–2018.
Source: RNTCP Programme Data, 2019.
Figure 7: Number of and rate examinations amongst presumptive TB patients – India, 2000–2018.
Source: RNTCPProgramme Data, 2019.
13 It is expected that the number and proportion of Since 2005, 9,421,533 patients received HIV examinations and bacteriologically conrmed testing during TB treatment, among these 453,713 patients will increase overtime with the proposed (4.8 percent) had positive results. HIV testing has installation and utilization of CB-NAAT, especially in substantially increased overtime; from less than 2 regions previously underperforming. The percent tested in 2005 to more than 89 percent proportion of drug-resistant patients diagnosed tested in 2018. During this time, the percent with and treated is also expected to increase with CB- positive results has signicantly declined (Figure 8). NAAT utilization with approved rapid diagnostic In 2018, 49,047 TB patients tested positive for HIV, tests, such as Xpert MTB/RIF and/or TrueNat MTB 44,142 (90 percent) received ART. and TrueNat MTB-RIF Dx.
Figure 8: Number of TB patients tested for HIV and percent with positive results – India, 2000–2018.
Source: RNTCP Programme Data, 2019.
It is expected that the number and proportion of substantially increased overtime; from less than 2 examinations and bacteriologically conrmed percent tested in 2005 to more than 89 percent patients will increase overtime with the proposed tested in 2018. During this time, the percent with installation and utilization of CB-NAAT, especially in positive results has signicantly declined (Figure 8). regions previously underperforming. The In 2018, 49,047 TB patients tested positive for HIV, proportion of drug-resistant patients diagnosed 44,142 (90 percent) received ART. and treated is also expected to increase with CB- NAAT utilization with approved rapid diagnostic Drug resistant tuberculosis tests, such as Xpert MTB/RIF and/or TrueNat MTB Substantial investments to scale up quality-assured and TrueNat MTB-RIF Dx. laboratory services throughout the country have been made since the 2015 JMM. Drug- Since 2005, 9,421,533 patients received HIV susceptibility testing (DST) is now available to detect testing during TB treatment, among these 453,713 resistance against the most commonly used anti-TB (4.8 percent) had positive results. HIV testing has drugs, paving the way for appropriate treatment
14 selection of people with drug-resistant TB through reported an estimated 130,000 (95% CL: 77,000, individualized, DST-guided regimens. During 198,000) patients with RR-TB, and an estimated 9 2007–2018, India tested 2,798,599 patients using RR-TB patients per 100,000 population.39 CB-NAAT and line-probe assays (LPAs). These tests — which remarkably reduce the time to MDR Treatment outcomes identication from months to days — detected At a national-level, TB treatment success (i.e., 236,725 drug-resistant TB patients. Among those completing treatment or sputum-smear conversion) tested, 166,472 (70%) were started on MDR-TB has been relatively stable amongst new sputum- treatment, including 11,948 patients with a more smear positive TB patients with drug susceptible severe form of extensively drug resistant TB (XDR- disease (Figure 9.) However, amongst patients with TB). In 2018, 797,263 patients were tested, drug-resistant TB treatment success remains poor 58,347 were diagnosed as drug-resistant (7%), and (below 50 percent) and there has been no 46,569 (80%) were started on PMDT. Provisional meaningful change for several years. Also, there is information for 2019 estimate that 67,241 RR- a worrisome trend for decline in treatment success /MDR-TB patients will be notied (85 percent of NSP amongst previously treated TB patients (Figure 9). target), and 59,945 (89%) placed on PMDT. The Death during DR-TB treatment remains relatively RNTCP is hereby commended for an impressive high, at 20 percent, and a substantial proportion of scale up and performance in a relatively short drug-resistant patients are lost to follow-up (18 period of time. However, despite a commitment to percent). A recent study suggested a signicant implement universal DST for people diagnosed with proportion of deaths during MDR-TB treatment may TB, a substantial proportion of TB patients 40 be attributed to TB-related causes. (approximately 64%) remain without an effective DST-guided treatment in 2018. In 2018, WHO
Figure 9: Annual proportions of successful treatment outcome among new sputum-smear positives, previously treated, and drug-resistant TB patient cohorts– India, 2012–2018*
Source: RNTCP Programme Data, 2019. *MDR cohort for 2017 not available.
39World Health Organization. Global tuberculosis report, 2019. WHO: Geneva, 2019. (WHO/CDS/TB/2019.15). 40Naik PR, Moonan PK, Nirgude AS, et al. Use of verbal autopsy to determine underlying cause of death during treatment of multidrug-resistant tuberculosis, India. Emerg Infect Dis. 2018;24(3):478–484.
15 Vulnerable populations: children, As seen with global TB notications, the proportion elderly, women, and social determinants of women with TB appears lower than men. Women-specic TB notications have increased for TB. across all age strata since 2012, but TB notications India also contributes to about one quarter of all are substantially higher for men (Figure 11). The pediatric cases in the world and about 10 percent of graphs in Figure 11 of TB notication rates for 2012 all notied cases were estimated to be in children and 2018 by sex and age-groups, suggest that 41 aged 0 – 14 years . Therefore, an estimated age-specic TB notication rates (per 100,000) 267,000 incident TB patients aged 0–14 occurred have been steadily higher with increasing age, in 2018. However, 129,510 children have been except for a lower rate in age group above 65. This notied in 2018 representing less than 6 percent of may reect missing patients in this older age group. all notications. Children continue to be relatively In contrast, TB rates are consistently lower in women underrepresented in the national TB surveillance than men in all age-groups. system. While the number of notications amongst 0–14-year-old patients substantially increased over Figure 11: Age- and sex-specic notication per the past ve years (n=95,709 in 2014 to 100,000 person – India, 2012 and 2018. n=129,510 in 2018), children are only a minor fraction of total notications each year (less than six percent annually). There also appears to be substantial geographic variation in pediatric notication (Figure 10).
Figure 10: Proportion of pediatric notications (0–14 year old) amongst all notications by geography – India, 2018.
Source: RNTCP Programme Data, 2019.
Source: RNTCP Programme Data, 2019.
41Dodd PJ, Gardiner E, Coghlan R, Seddon JA. Burden of childhood tuberculosis in 22 high-burden countries: a mathematical modelling study. Lancet Glob Health. 2014;2(8):e453-9.
16 Socio-economic determinants of health associated systematic assessment of the burden of socio- with TB include the behavioral, economic, political, economic determinants of TB in India. The only social and conditions that inuence how and where quantication of the true magnitude and people are born, develop, live, work, and age.42 contribution of these factors toward the burden of Apart from accessing medical care, there is TB in India can be extrapolated from the Global increasing evidence of the role of these factors in Burden of Disease study.45 This analysis quantied health and TB epidemiology.43 These determinants the contribution of tobacco, alcohol and raised inuence all stages of TB pathogenesis: risk of fasting plasma glucose (including effects of exposure, susceptibility for progression to disease, diabetes and pre-diabetes) to the TB burden in time to diagnosis, time to treatment, treatment India: 4 percent, 11 percent and 11 percent compliance, development of drug resistance, respectively for the year 2010. There is no direct relapse, recurrent disease, post-treatment estimate of the contribution of the national disability, and ultimately cure.44 prevalence of poverty, undernutrition, India is simultaneously burdened by multiple health overcrowding, and air quality on measures of TB conditions that have been associated with TB, disease burden. Nevertheless, WHO published including undernutrition, diabetes, excessive estimates of the number of TB patients attributable alcohol use, and tobacco smoking. These to the ve main risk factors (HIV, diabetes, smoking, syndemics (term developed by Merrill Singer in harmful use of alcohol, and undernourishment) 1990s to describe the aggregation of two or more based on mathematical modeling and assumes 46 concurrent or sequential epidemics or disease from the Global Burden of Disease study and 47 clusters in a population with biological interactions, other sources (Figure 12). Based on this analysis, which exacerbate the prognosis and burden of undernutrition contributed the largest fraction of TB disease) are further fueled by poverty, indoor (e.g. patients in 2018, followed by harmful alcohol use, solid cooking fuels) and outdoor air pollution, and smoking, diabetes, and HIV, respectively. overcrowding. To date, there has been no
Figure 12: Estimated number of TB patients attributable to social determinants of disease – India, 2018.
Source. Global tuberculosis report, 2019.
42Lönnroth K, Castro KG, Chakaya JM, et al. Tuberculosis control and elimination 2010–50: cure, care, and social development. Lancet. 2010; 375(9728):1814–1829. 43Duarte R, Lönnroth K, Carvalho C, et al. Tuberculosis, social determinants and co-morbidities (including HIV). Pulmonology. 2018;24(2):115-119. 44Hargreaves JR, Boccia D, Evans CA, et al. The social determinants of tuberculosis: from evidence to action. Am J Public Health. 2011;101(4):654-62. 45Murray CJ, Ortblad KF, Guinovart C, et al. Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;384(9947):1005-70. 46Murray CJ, Ortblad KF, Guinovart C, et al. Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;384(9947):1005-70. 47World Health Organization. Global tuberculosis report, 2019. WHO: Geneva, 2019. (WHO/CDS/TB/2019.15).
17 To date, there has been no nationally representative information ecosystem within the health system, yet study of catastrophic costs for TB in India. Smaller, there is limited interoperability between diverse local studies (with varying methodologies, applications. Fourth, patients with microbiological populations and settings) suggest that 7 to 32 test results available after notication cannot be percent of TB patients in India experience changed in NIKSHAY. Hence, there is a strong catastrophic costs during the diagnosis and potential for misclassication of notied cases as treatment of TB.48,49,50,51 clinically diagnosed (vs. bacteriologically- conrmed) within the national TB surveillance Surveillance, Monitoring and Evaluation system. Fifth, there are unrealistic outcome-based targets, not consistently grounded by eld reality. The enhancement of the national surveillance system, Finally, there is limited capacity for epidemiologic based on NIKSHAY, since the 2015 JMM was analysis and using data for action throughout the commendable and unprecedented. NIKSHAY was various levels of the national TB programme. readily available and used by all RNTCP staff, and witnessed at all eld visits during this JMM. Most staff used the NIKSHAY mobile phone application, or Recommendations using RNTCP-supplied e-tablets. NIKSHAY was used 1. Build and mentor a strong surveillance, for real-time reporting and recording of key variable epidemiology, and monitoring and evaluation (e.g., name, age, sex, address, treatment start date, workforce. Further investments in TB laboratory results, HIV status). The use of NIKSHAY surveillance staff and systems for accurate, for real-time treatment adherence documentation complete, and timely information that ensures was lagging and, in most instances, delayed by up to high-quality, effective service delivery, one month. monitors performance, and detects and responds to community transmission. A We observed gaps in a few key surveillance areas. network of national-, state-, and district-level First, data verication, particularly for accuracy, is TB Surveillance Units should be established by not consistent nor regular throughout the country. 2020. Augment the surveillance network with There is no plan in place to check for data technical assistance to help address emerging verication, or timeliness of entry. Second, we priorities, building communities of practice, observed duplicative systems of recording using local data for local action, and rapidly information (e.g. laboratory and treatment hard- responding to outbreaks. copy registries), and nearly all eld visits reported back the maintenance of both paper-based and 2. Use local data for local action; create process electronic records. This often doubles recording indicators that are vital for larger outcomes. A and reporting burdens, and opens the surveillance network of National-, state-, and district-level system to potential errors and/or duplications. TB Surveillance Units (noted above) should Third, there is an expanding and evolving develop processes for ensuring and maintaining accurate, complete, and timely
48Prasanna T, Jeyashree K, Chinnakali P, et al. Catastrophic costs of tuberculosis care: a mixed methods study from Puducherry, India. Glob Health Action. 2018;11(1):1477493. 49 Sarin R, Vohra V, Singla N, et al. Identifying costs contributing to catastrophic expenditure among TB patients registered under RNTCP in Delhi metro city in India. Indian J Tuberc. 2019;66(1):150-157. 50Shewade HD, Gupta V, Satyanarayana S, et al. Active case nding among marginalised and vulnerable populations reduces catastrophic costs due to tuberculosis diagnosis. Glob Health Action. 2018;11(1):1494897. 51Veesa KS, John KR, Moonan PK, et al. Diagnostic pathways and direct medical costs incurred by new adult pulmonary tuberculosis patients prior to anti- tuberculosis treatment Tamil Nadu, India. PLoS One. 2018;13(2):e0191591.
18 information in NIKSHAY. This team 3. Develop user-friendly, virtual “workspaces” should assess local data for trends in and data visualizations to prompt local epidemiology, service delivery, monitors public health action. NIKSHAY should performance, and detects and responds to include modules that prioritize contact community transmission (e.g., outbreaks). investigation information, TPT surveillance, Formal surveillance data integrity plans and post-treatment surveillance. and processes at the national, state 4. Accelerate alignment and streamline and district levels should be established all health information systems and by 2020. These plans should include applications. (Prioritize TB LIMS) processes for data validation and 5. Phase out paper-based recording systems verication. to eliminate duplication of effort.
19 2. Findings and Recommendations
The following ndings, observations, and ambition of the RNTCP and GoI in addressing subsequent recommendations are the product of this issue – a full 97 percent of additional the two-week intensive 2019 WHO-GoI JMM. notications for 2015 to 2020 are projected to These observations and recommendations are come from private sector providers (Table 3). framed around the four pillars of the NSP, 2017- Therefore, NSP success requires private 2025 (Build, Detect, Treat, Prevent), and provided provider engagement success - across the for each of twelve thematic areas. entire diagnostic and treatment cascade. This requires a doubling of the national TB 2.1 Build response – converting a partial program (mostly covering the public sector) to a full 2.1.1 Partnerships and Private program (covering both public and private Provider Engagement sectors), and include all the necessary It has been estimated that up to 70 percent of expansions in capacity for fund ows, human TB patients in India seek care from private resources, logistics, patient support systems, providers. The NSP targets indicate the and monitoring of outcomes.
Table 3: NSP’s Baseline and Targets for Total TB Patient Notication and Total TB Patient Notication from Private Providers Baseline Target OUTCOME INDICATORS 2015 2020 2023 2025 1. Total TB patient notication (in millions) 1.74 3.6 2.7 2 2. Totale patint Private providers notication (in millions) 0.19 2 1.5 1.2 Source: National Strategic Plan for Tuberculosis 2017-25: Elimination by 2025
The NSP also outlines the various approaches necessary, and the associated sub-targets in this effort, which can be seen in Figure 13 below.
Figure 13: Reaching TB Patients in the Private Sector
Source: RNTCP
20 Private provider engagement (PPE) in India was f. Guidance for contracting these and other historically a combination of two efforts: (1) services was launched during the second engagement of private medical colleges, which week of the 2019 JMM was generally successful and continues to date; g. Plan is in place to contract for ~350/750 and (2) pilot engagement of other private providers districts within the coming nancial year prior to 2018, which produced some good results and lessons but relied heavily on donor funding, 3. RNTCP direct engagement and did not persist (or expand) after projects a. Primarily using existing RNTCP staff ended. Domestic investments in PIPs and PPSAs (Public-Private Mix (PPM) coordinator to have facilitated private sector engagement but direct and motivate, TBHVs to track have not been expanded to scale. patients) b. So far has yielded ~2/3 of private The main models for PPE more recently and their notications characteristics are: c. In the JMM team’s assessment, this is 1. Universal Access to TB Care (UATBC) currently a weak model that needs a. Three major sites (Mumbai, Patna, strengthening Mehsana) starting in 2014 d. Can be supported by Schedule H1 drug b. Vouchers for program drugs and (i.e., drugs that are only sold by diagnostics allowed tracking of patients prescription of medical practitioners) through the cascade notication: where operational, the H1 c. Use of call center for notication and system can identify patients who can then adherence support be assigned to an HV d. Full patient cascade e. Supported by NIKSHAY – and some hospital record systems may become 2. Private Provider Support Agency (PPSA) interoperable with NIKSHAY a. Evolved from the UATBC approach f. Overall, the remaining tasks beyond b. Main model being pursued now and in the notication (Universal Drug Susceptibility near-future plans Testing (UDST), HIV, and Diabetes (/DM) c. Like UATBC, signicant HR for provider screening, outcomes, etc.) still have engagement, linkages, and patient notable gaps in performance support. In the JMM team’s judgement, it is essential to have such intensive support Achievements when there is a high density of private The RNTCP has made notable progress in private providers (e.g., urban) and/or low ratio of provider engagement. Achievements to date are public staff: TB patients listed below: d. Like UATBC, the concept is outsourced • Interface agency approach (PPSA) management, and the intention was to • Gazette Notication for Mandatory TB improve diagnostic processes and use Notication program diagnostics and drugs • Improved NIKSHAY e. In reality, current PPSAs rely primarily on physicians’ own diagnostic processes (only • Establishment and Use of the Call Centre 25% of PPSA notications are • Incentives for TB Notication bacteriologically conrmed (BK+)) and on • NIKSHAY Poshan Yojana (NPY) patients buying market drugs (only 7% of PPSA notications use program FDCs)
21 Additionally, private sector notications have producing both results and lessons for the future, increased drastically (Figure 14) to reach over half a and 145,000 and 35,000 private sector patients million nationally. This major achievement has have beneted from the use of public sector CB- greatly improved surveillance and awareness of the NAATs and xed-dose combination (FDC) drug true TB burden, and made important inroads on programs, respectively. More recently, 48 new bridging the cultural and programmatic divide PPSAs have been contracted on an output-based between public and private sectors. To help drive nancing arrangement through domestic budget – this effort, 48 patient provider support agencies since this is a recent effort, these PPSAs are not yet (PPSAs; described further below) have been producing results. operating using input-based nancing and
Figure 14: TB Patients Notied from the Private Sector, 2012-18
Source: RNTCP
Table 4: TB Patient Notication from the Private Sector and Other TB Continuity of Care Indicators
22 Figure 15: Heat Maps Depicting the Variation by State of Private Provider TB Case Notications and Private Provider TB Drug Sales
23 Challenges and Opportunities Shift #1: Output-based contracting Challenges: Output-based contracting means that service • Less than 80% of privately notied patients providers are paid for the results (e.g., notications, (even in PPSA) currently don't benet from volume of testing, achievement of quality of care programme services52 measures, and successful treatment outcomes) rather than for inputs (e.g., stafng costs, • Weak government capacity for contract computers, transportation, training, or other management commodities). It is commonly used in health • Especially, unreliability of GoI payment systems globally in both public and private systems (noted during JMM site visits, but not yet – and its increased use is also an important part of quantitated comprehensively) the evolution of health systems as countries grow • Limited experience of potential economically. Examples in India include PMJAY, implementers in performing PPSA functions which pays hospitals for each package of care • Data challenges: outcomes, transfers, provided. And many low- and middle-income duplicates, etc. countries adopt output-based contracting and results-based nancing to contract Opportunities: Nongovernmental Organizations (NGOs) to • Excellent NSP and high-level commitment deliver public health programs (screening, to ambitious PPE maternal care, etc.). • Introduction of digital data and adherence The rationale, or expected advantages of output- technologies based contracting, include: • New Partnership Guidance and pending • More accountability of the implementer for Technical Support Units (TSUs) the outcome • Existing engagement models • More exibility to the implementer on • Increased enforcement of mandatory having innovative ways to implement notication / Schedule H-1 in some areas • Reduced micro-management by public • Emerging private business models: program and less time spent on rules on consolidation, chains, e-pharmacies, etc. inputs, approaches, and processes related • Expansion of Pradhan Mantri Jan Arogya to implementation Yojana (PMJAY) • Emerging Articial Intelligence (AI) tools for The rst step to implementing output-based X- ray reading and predictive analysis contracting is identifying services appropriate for • CTD's collaboration with AI partners output-based contracting (e.g. the quantity of services must be easy to measure). For TB, these Main Recommendations and other issues are addressed in the newly issued Guidance Document on Partnerships, which is a The JMM team applauds India's level of ambition exible but critical guide to the way forward on and effort in this area, but also recognizes the vast contracting both PPSAs and other subsets of TB amount of work still remaining to achieve quality services. PPE at scale. To analyze this in more depth, we now examine two big shifts that the JMM team believes Output-based contracting raises a number of risks – are necessary to move this overall effort forwards: examples of these potential risks are outlined in the Table 5 below, along with mitigation steps that have 1. Moving to output-based contracting been put in place or need to be pursued. 2. Improved models to get beyond notication
52BK+, UDST, FDC, NPY, PP incentive, public health actions, treatment support, patient information etc.
24 Table 5: Examples of potential risks and corresponding mitigative steps for transitioning to output- based contracting.
Risk(s) Mitigation Insufcient budget under PPM, PPSA contracting Ongoing advocacy for fund availability. line at both state and national level.
Limited government capacity to: Build government capacity. - Scope specications and assess market, to Provide contract templates in guidance and create negotiate a reasonable contract; additional tools as needed. - Stick with output-based design and avoid Increased contracting, nancial management and micromanagement; monitoring and evaluation (M&E) staff via the - Avoid procurement and contracting delays planned rollout of the TSUs. that could lead to gaps in services or delay Consider centralized contracting for some settings. payment to nancially fragile Implementing Partners (IPs) (historically National Health Mission (NHM) mechanisms to move les have been slow).
Limited capacity of IPs to estimate, plan, and Build capacity on the guidelines, different deliver required services. contracting models, and how to design and submit proposals under these new models. Consider national purchasing of private lab and drug services, especially for use in areas without experienced implementers. Add a project management system to NIKSHAY so that every implementer doesn't need to create their own such system.
You get what you pay for: a forgotten indicator = a The guidance document(s) include(s) all the neglected area. relevant and proposed indicators.
Danger that payment targets could motivate the Implement regular and spontaneous audits, and submission of bad data monitoring processes (household visits, drug rells, etc.) that can be triangulated against the main reported outcome.
Since transitioning from input-based contracting to output-based contracting is such a signicant shift in mindset, a deliberate approach to change management is crucial. A suggested framework for such a process is below (Figure 16).
25 Figure 16: Example framework for shifting from input- to output-based contracting.
Shift #2: Improved models to get beyond For both the PPSA and RNTCP direct engagement notication models, improving the models requires: 1. More complete notication: In PPE, there has been an invaluable shift from donor-funded projects to nationally owned efforts, a. Schedule H1 drug monitoring can identify but some elements of quality have been lost or non-notied TB patients. The caveat: H1 is require strengthening, as seen by the low only truly operational in 7-10 states, and performance on indicators beyond notication. there is a need for simpler tools to link the Access to donor or publicly funded diagnostics and H1 and NIKSHAY systems; drugs was a critical component of UATBC not only b. “Soft” engagement: Indian Medical to reduce the nancial burden on patients, but also Association (IMA) to disseminate to improve the quality of diagnosis and care and to messages to its members, advocacy, and track patients through the treatment cascade – if a monitoring of outcomes. program is paying for the commodities, it can “see” 2. Tracking patients until treatment outcome: into the operation of the program. This public a. Schedule H1 (above) and/or vouchers (see supply of commodities was somewhat lost in many below) can indicate progression of of the subsequent PPSAs, but the JMM team treatment; recommends a strong effort to re-establish a focus b. Auditing system are needed to verify in this area. A number of options for this are outcomes; outlined below, and the JMM team supports the continued exibility, as expressed in the Guidance c. To track TB patients after transfer out, the Document on Partnerships, on encouraging local use of Aadhaar unique identity numbers decision-making that aligns such choices to the will be critical, and/or TB Health Visitor local situation. Indeed, the use of output-based (TBHV) or PPSA staff can nd out directly nancing puts more of this decision-making in the from patients hands of the implementing organizations. 3. Diagnostics and drugs: For PPSAs, RNTCP can
26 also consider national purchasing of private lab about private sector stock-outs, the avoidance and drug services, especially for use in areas of such stock-outs can be one of the payment without experienced implementing partners who metrics in the contract. Establishing such a may struggle to put together the many requisite scheme requires the following: elements for a strong PPSA. (See below) a. Negotiate a nal sales price with pharmaceutical companies, including the Drug Access Options: cost of operating the supply chain, and The JMM team notes the heavy emphasis in the distribution markups (note: these costs in Guidance Document on Partnerships on the public sector supply chain are “hidden” programme-supplied FDCs. This will be under other budget line items); appropriate in some settings but does run the risk of b. Use existing private pharma supply chain interruption in supply or stockouts leading to to get drugs to selected pharmacies; mistrust of the public sector by private providers and c. Distribute vouchers to physician providers; risks to private patients, poor contract performance d. Pay pharmacies via voucher. (since the public sector did not hold up its end of the contract), and survival and funding of the overall Diagnostic Access Options: scheme. The JMM team therefore recommends research, in at least some locations, of the last three Similar themes emerge in the area of access to options listed below, which make use of the private diagnostics (and in both areas, the suggested sector supply chain either partially or completely. approaches can be strengthened via Direct Benet Transfer (DBT) payments to patients and providers). 1. Private patient collects program drugs from For diagnostics, there are insufcient CB-NAAT primary health centre (PHC) (only viable if machines, lab technicians and chest X-ray (CXR) private patients are willing to shift into relying capacity in the public sector, so the JMM team does on drugs provided by public services). not consider it viable to use only public diagnostic 2. Program (or PPSA) places a full course of drugs capacities. with the provider; regular calls by TBHVs (or 1. Public purchasing of private lab services – with PPSA staff) to check progress (a challenging embedded cost of staff, machine, and option for supply chain management since cartridges. For cartridges, these can be India does not use patient-wise boxes). purchased by the private sector under the 3. Place program drugs in local private Initiative for Promoting Affordable and Quality pharmacies, or Jan-Aushadhi (initiative to TB Tests (IPAQT) concessionary price (currently make quality drugs readily available in patients pay 1600-2200 rupees ($USD23-30), dedicated stores). The program then pays the but it should now be the public sector that picks pharmacy 100 rupees per month per patient up the ultimate cost (e.g., via vouchers). for their dispensing services. This scheme is 2. Use of the national free diagnostic scheme: in already operational in Mumbai and Mehsana. private labs that are co-located with district 4. Place program drugs in the regional stores of hospitals, the public sector pays for services, pharmacy chains, and pay the chain both for including the cost of the private lab organizing the operation of the local supply chain and for sputum transport. dispensing. 5. Use online pharmacies, especially in sites most RNTCP Direct Engagement: chemists have stopped stocking anti- There are a number of recommendations that are tubercular treatment (ATT). specic to RNTCP direct engagement, since this 6. Vouchers for drugs that ow through the model has limited staff: private supply chain. If there are concerns
27 1. Additional staff recruitment: States and primary care sector, including AYUSH and districts require budgeting guidance on asking other registered medical practitioners (e.g., for more staff to manage both public and World Health Partners (WHP) experience) private patients. c. Improve performance by using indicators 2. Document and disseminate existing models across the full cascade of diagnosis and care. for linking patients identied via Schedule H1 2. PPSAs and other partnerships: drug notication to TBHVs. a. Contract TSUs as soon as possible; provide 3. For tracking patients: Set the expectations that extensive training and handholding on (a) all patients (public and private) in a TB Unit application of new Guidance Document (TU) are the responsibility of the public TU on Partnerships; adjust guidance staff, and (b) TBHVs call (check in) with notied frequently in light of experience. private TB patients at least once a month. See b. CTD/National Technical Support Unit also Schedule H1 drug and voucher discussion (NTSU) to monitor timeliness and above to help track patient progress. completeness of payment to IPs, and 4. Leverage professional associations for resolve problems promptly as required. advocacy, awareness and further education. c. External funding partners to consider co- 5. Limited contracting of the most challenging pieces. funding, to de-risk the GoI payments to Ips. 6. Build capacity of PPM coordinators, Senior d. Make maximum use of the Call Centres on Treatment Supervisor (STS) and TBHVs. notication, voucher validation, follow-up calls to patients53 . Additional Recommendations: 3. CTD to provide guidance on strengthening the The ambition and approaches outlined here are RNTCP direct engagement model. already present in the NSP, with the exception of the 4. Strengthen processes to verify reported shift to output-based nancing. Thus, the JMM outcomes (particularly on treatment success). recommendations focus on strengthening the 5. Ensure that all NIKSHAY improvement cycles existing programmatic directions rather than consider functionalities for engaging private introducing a signicant change in direction – but providers. with the recognition that important NSP elements 6. Public sector to reimburse the purchase of require considerable work. Thus, in addition to the privately-supplied molecular diagnostics and suggestions above, the JMM recommends the FDCs, capitalizing on efciencies in private following: supply chains. 1. Clarify ambition level: 7. Empanelment of selected private hospitals as PMDT providers, and inclusion of these a. Aim for full coverage, using drug volumes facilities in supply chain for Second Line Drugs as the denominator. (SLDs) programs. b. Aim for more intense coverage, reaching 8. Use and expand Schedule H-1 drug reporting more providers to catch patients earlier. to identify TB patients, and improve systems to This prioritization of early detection should link from Schedule H1 to NIKSHAY so that include extending rapid molecular programme services are extended to such diagnostics to the “bottom of the pyramid” clients.
53E.g., the use of the call center in Patna enabled them to use a staff to patient ratio of 1:32 versus the 1:15 seen in other efforts.
28 9. Medium to long term: Work with PMJAY to test diagnostics. mechanisms for including outpatient TB services in social health insurance. Consider 2.1.2 Multisectoral Engagement and using fee for service payments for TB under Accountability PMJAY, since this aligns with the current use of The NSP (2017-2025) presented well-dened DBT for specic payments, and with both the key strategies for multisectoral engagement, positive and negative lessons in other Asian 54 though they were spread across a number of countries. sections of the strategy. These included: 10. Conduct regular assessments: prescription • Working across ministries/stakeholders in audits on quality of prescribing; standardized “Mission mode”; patients on quality of diagnosis and treatment practices; time and number of providers to • Proposing TB impact modelling on social reach care; proportion of private diagnoses determinants; who are truly TB. • Addressing social determinants through 11. NTSU to ensure cross-learning visits to multi-sectoral approach; promote a learning agenda on PPSAs. • Mapping of key populations and strategies for 12. Scale up bundled models of chest X-ray AI, some populations; NAAT, Integrated Digital Adherence • Prioritized locally-dened groups for active Technology (IDAT) and electronic pharmacies. case nding (ACF) within urban, rural and tribal areas Key Messages The NSP also included suggested actions for Notifying TB patients is an important gateway, but corporate sector involvement and urban TB control, does not produce the desired public health impact – and which are addressed in another section of this and risks encouraging complacency. We must also report (see sections on Urban Tuberculosis and extend the full range of programme services55 in a Health Systems Strengthening, respectively). veriable way. Effective notication needs to be dened as notication linked to care (complete and During the 2019 JMM, the teams looked at successful treatment). progress made on multisectoral engagement, 1. Both major models need extensive support related to the points above and commitments made and adaptation: at the UNHLM on TB in September 2018, related to a. Performance-based contracting is bold multisectoral accountability, and major points and needed. It requires urgent contracting regarding multisectoral collaboration and high- of TSUs by March 2020, and rollout of the level review recommended in the Multisectoral Guidance Document on Partnerships, Accountability Framework for TB (2019). This tools, capacity building, digital systems, Framework was produced at the request of the and efcient payment and contract World Health Assembly and the United Nations management measures. General Assembly. Given the time constraints, b. RNTCP direct engagement model requires members of the JMM were not able to meet with documentation, guidance, and tools. counterparts in other Ministries during its two-week review. Therefore, this brief assessment relied on briengs provided by CTD leadership and staff, and 2. Strongly consider using public funds to relevant written documents, as well as impressions purchase privately supplied drugs and gained during some eld visits.
54Wells WA, Stallworthy G, Balsara Z. How tuberculosis programs can navigate the world of social health insurance. Int J Tuberc Lung Dis. 2019 Jan 1;23(1):26-37. doi: 10.5588/ijtld.18.0289. 55BK+, UDST, FDC, NPY, PP incentive, public health actions, treatment support, patient information etc.
29 Further, the NSP calls for “mission-mode” actions. multisectoral actions, including the By denition, a “mission mode” high-level national groundbreaking TB elimination plan for TB elimination effort would require clearly dened Kerala and for Himachal Pradesh as well objectives, scopes, implementation timelines and TB-free city examples. milestones, measurable outcomes, and service - A National Multisectoral Action levels. This is yet to be fully realized within and Framework on a TB-Free India provides beyond the health sector to enable accountability an excellent annex on other potential and fulllment of vision and goals towards ending state-level schemes for further TB by 2025. The Prime Minister has made bold providing TB patient support including commitments and the MoHFW has set forth social benets available beyond TB and approaches to aim to meet those commitments outside of the health sector. through the NSP and additional measures. - Some state teams saw outstanding efforts in place working with tribal Achievements development authorities in reaching • The MoHFW has established an Inter- some tribal populations by using Ministerial Committee for TB with 25 human resources and budgets ministries participating so far. It has set its available through these authorities and TORs, held two meetings and has the coordinating activities through RNTCP intention to create a joint operational and general health staff. working group. - Work with Railways appears well • With help from partners, the RNTCP has developed, as well as with some already developed and published a a industries. National Multisectoral Action Framework • The existence of major new Government- on a TB-Free India. This document outlines wide initiatives with ample resources, high- key efforts planned, particularly with level support and momentum, including regard to health workplaces and corporate Ayushman Bharat, Public Distribution contribution and engagement. An System (PDS), supplementary nutrition operational plan for this document is the programs, Smart Cities, Ujjwala Yojana, next step in fully operationalizing the key Swachh Bharat all provide major activities. opportunities for integration of, and • Memorandums of Understanding (MOUs) collaborations on, objectives for ending TB. have been signed with the Ministries of Defence (MoD); Railways; and Ayurveda, Challenges and Opportunities Yoga & Naturopathy, Unani, Siddha, Sowa As these are relatively early days for many elements Rigpa and Homoeopathy (AYUSH) for TB of multisectoral engagement, signicant activities. challenges were also noted under each of the areas - Special initiatives have already been noted above. launched with the Department of Post • Important progress has been made in the (DoP), Ministry of Labour & TB response because of highest-level Employment, Ministry of Panchayati Raj, engagement and commitments made and Ministry of Women and Child through increased budgets. Yet some of Development (MWCD) for TB-free the structures needed to enable a mission- workplaces. mode effort with actions and accountability • There is a wide array of state- and district- still need to be established and activated. level good practice examples of • Lack of information and clarity of the
30 accountability of the Inter-Ministerial a. This Board should include the highest-level Committee. participation from central and state levels, • With 25 ministries engaged, the focus of and from all major stakeholders including the collaboration now appears diffuse. civil society representation. • While the rst round of MOUs is an b. An operational body should accompany important step, there appears to be an this high-level board to help manage exclusion of some of the top priority regular interactions. Lessons learned from ministries. the successful eradication of Polio in India, • Contributions to ACF efforts in some areas and other successful elimination efforts, have relatively low yield, suggesting a need indicate that regular government divisions to shift strategies to better identify and cannot pursue these efforts through target populations for ACF activities. existing management structures alone. • While it is commendable that a National c. This TB Elimination Board could also serve Multisectoral Action Framework on a TB- a critical need for a periodic review body. Free Indiaa exists, there may be some This would help India full its commitment missed opportunities. to have a high-level accountability mechanism as set out in the political - It was difcult to assess whether the NSP declaration of the UNHLM. elements on modelling on the social determinants of TB were taken forward, 3. Functionalize and strengthen existing Civil and whether actions had been Society Forums. These Forums seem to exist at advanced on mapping key populations national and state/district levels but they need and interventions. to be activated and robustly operated to drive scaled-up action and as another key level of - This is a signicant element of baseline multisectoral accountability. work that can contribute to robust planning for multisectoral action. 4. Consider formalizing a TB multisectoral accountability framework within the MoHFW. Recommendations The core of the framework could be the TB Elimination Board. 1. Enter full “mission-mode” within and beyond a. This would further help strengthen the health sector. As suggested and clearly measures already taken for enhanced articulated in the NSP, “mission-mode” actions multisectoral engagement. are needed to enable accountability and fullment of vision and goals towards ending 5. Provide more information and clarity are TB by 2025. needed on accountability of the Inter- Ministerial Committee, including who the a. Using the support of the Prime Minister’s Committee is accountable to and how it will be bold commitments, the MoHFW now needs made robust in its actions. to take action on activities already set forth in the NSP and additional measures to a. It could report to the overall high-level TB meet those commitments. Elimination Board (see more below). 2. Establish a functional TB Elimination Board. b. Roles and responsibilities need further As envisioned in the NSP, a whole-of- clarication, including how this government approach, including multisectoral Committee relates to actions to be taken at engagement, is needed to overcome the state- and district-level. Further, critical and persisting bottlenecks in budgetary responsibilities also need implementation. clarication.
56The last 2015 JMM included TORs for addressing key populations while the 2019 JMM did not.
31 c. Its operational plan will need to clearly contribute to ending TB given their scope and state immediate and medium-term potential: including, Ayushman Bharat, PDS, deliverables and dene performance supplementary nutrition programs, Smart indicators. Cities, Ujjwala Yojana, Swachh Bharat. d. There needs to be a clear secretariat/focal point within the MoHFW. Key Messages 6. Given the limited capacity to support the 1. Drive multisectoral action, based on the right multisectoral engagement so far, a focused to health, via a TB Elimination Board and intensive effort with a few ministries that drive state/local counterparts, and inter-sectoral budgetary commitments and accountable Committees, operational plans (with actions may produce results that can, as rst ambitious and achievable deliverables for examples, drive much greater commitments priority sectors, with indicators and from more ministries thereafter. accountability, and stakeholder engagement. 7. For ACF activities, focused high-priority This should be done in early 2020. multisectoral engagement with relevant 2. Engagement of stakeholders within and ministries, specically with the Ministries of beyond health, and within and beyond Home Affairs (MHA), Mines, and Labour & government, especially civil society and Employment, will likely increase systematic independent voices are essential. screening efforts, reporting on results, and 3. India can and should be a global pathnder action taken for diagnosis and care based on for multisectoral accountability. the results. a. Key populations (e.g. miners/people 2.1.3 Health System Strengthening working in dust-generating industries and The NSP (2017-2025) explains a number of key associated communities; prisoners and strategies for health system strengthening (HSS). detainees; etc.) should produce higher The JMM chose to group strategies to focus on ve yields. main areas: health nancing, governance, b. Consider publishing special reports on procurement, nancial ows, and HR. Each section actions taken among focused populations below is organized under these main themes. and tribal populations nationally. 8. To successfully enter mission-mode across all Achievements sectors, an increase in human resources (HR) Health Financing: and nancial support from key ministries • There is strong political commitment at the beyond health will be needed. These highest levels that is matched by nancial resources should be carefully measured and commitment. monitored on a periodic basis (at least yearly). • A rapid budget increase from 2015 to 9. Revisit the National Multisectoral Action 2019 was quickly implemented to support Framework on a TB-Free India through a the ambitious goals of the NSP (2017- national consultation to assess whether its 2025). The RNTCP budget more than major focus on the workplace can be doubled since the launch of the NSP expanded to further address other (Figure 17). multisectoral challenges. This consultation should include key non-governmental • Innovative and results-based nancing for stakeholders working on health across sectors high impact NSP interventions have been and affected people and communities. identied (i.e. private sector scale-up and DBT). 10. Take action to explicitly state how major national initiatives/programmes are and can
32 Figure 17: RNTCP Budgets and Expenditures, 2014 to 2019
Source: RNTCP Programme Data, 2019.
Governance: Financial Flow: • The NSP clearly outlines key governance • In 2018-19, 71 percent of the annual budget interventions and structures that need to be in (Rs. 3140 crores) was spent as per the data place to end TB by 2025. made available during the JMM. This includes • Multiple expert groups are in place to assist in 83 percent of grant-in-aid provided to and the restructuring and expansion of the CTD. spent by the states (Rs. 1017.19 crores • Emphasis has been placed on increasing expended against the release of Rs. 1224.64 engagement with the private health sector and crores to states). civil society organizations (CSOs). • The electronic Public Financial Management System (PFMS) was rolled out to all the districts Procurement: to improve the efciency of district-level • Seven of the ten positions for Procurement and accounting. Supply Management (PSM) experts at the national level have been lled. Human Resources (HR): • The NIKSHAY Aushadhi programme has been • HR levels better aligned to the need and to developed and deployed at all levels. block level TB units • A government order was issued to mitigate • In 2014, there was one Senior Treatment acute local drug shortages by facilitating Supervisor (STS) per 4.13 lakh population; in emergency drug procurement for up to 25 2019, there is one STS per 2.74 lakh percent of the states’ total annual drug population. requirement for all drugs. • Workload Assessment for undertaking the new • Efforts have been made to begin expanding initiatives outlined in the NSP is in process and access to quality TB drugs supply for the nearing completion. private sector. • Training contents, methodology, and tools • Successfully using domestic budget streams for have been updated with new modules and procurement of molecular diagnostics, contents. including reagents, for the rst time. • A performance-based incentive system has been designed and approved to help address the implementation gaps in performance of frontline workers.
33 Challenges and Opportunities Figure 18: NIKSHAY Aushadi report on the percentage of state drug stores (SDS), district Health Financing: drug stores (DDS), tuberculosis unit (TU) drug • Lack of assessment of NSP cost and budgetary stores, and peripheral health institution (PHI) needs past 2021. drug stores active. There is a noticeable decrease in stores from the national to peripheral level • No system in place to monitor out-of-pocket and catastrophic health expenditures for TB. • Continued gaps in coordination with the . National Health Authority (NHA) to better implement AB-PMJAY schemes for TB patients.
Governance: • While interventions are clearly articulated in the NSP, there is a lack of implementation at all required levels.
Procurement: • Continued issues regarding tender failures Financial Flow: and long lead times for procurement. The • Insufcient, incomplete and untimely fund ow lead time for the Central Medical Services from RNTCP budgets to states. Society (CMSS) can be anywhere from 13 to 15 months, while the Global Drug Facility (GDF) • Burn rate and budget release varies by states is typically six to eight months. (Figures 19 and 20). • Ongoing challenges with low stock or • Marked delays (range of 52-262 days) in shortages of necessary lab and drug supplies release of the rst installment of the budget. (e.g. unavailability of adequate buffer stocks, shortages of SLDs (cycloserine) and other anti- 19: This graph shows the wide Figure range in TB drugs (rifabutin, pyridoxine). the burn rate of 2018-2019 by region. • While NIKSHAY Aushadi is able to generate a myriad of useful reports to support drug quantication and inventory management, there is a lack of capacity at all levels to use, interpret and act on available data. • Absence of a central level agency for post- dispatch quality assurance for more than 12 months • Persisting lack of or insufcient infrastructure of drug stores in some states (Figure 18). • Central, state and district level warehouses continue to house expired medicines in their already limited space. • In some states, there continues to be a lack of formalized, reliable transportation mechanisms for state to district/sub-district level transfer.
34 Figure 20: This graph shows the range in the percentage of the 2018-2019 budget released by region.
• Inefcacies in monitoring budget and example, untimely submission of audit reports expenditures. At the state level, excel sheets by state and delayed appointment of auditor separate and independent from the PFMS are rms by NHM persists. used to track nancials. Human Resources: • Lack of capacity for implementing and • High vacancy rates of key positions at all monitoring important nancial systems. For levels, including the general health system and example, technical staff (i.e. STS, state RNTCP (Figures 21, 22, 23, and 24). tuberculosis laboratory supervisor (STLS), etc.) Ø Some project implementation plans (PIPs) are responsible for accounting entries and included proposals to recruit contractual DBT transactions. staff but this was not approved. • Delays in effective auditing processes. For
Figure 21: The graph above represents the vacancy rate (%) for state-level positions.
35 Figure 22: The graph above represents the vacancy rate (%) for district-level positions.
Figure 23: The graph above shows the number Figure 24: The graph above shows the number of approved positions for the culture and drug of approved positions for district-level sensitivity testing (CDST) labs and the number accountants and the number of actual district- of actual lled positions at the CDST labs. level accountant positions lled.
CDST labs HR Status District Accountants HR Status
*39% vacancy *27% vacancy
• The Terms of Reference (TOR) for staff at the personnel, gaps persist. For example, a state, district and sub-district level are not needs assessment has not been completed representative of the expanded, ambitious at all levels and e-training modules are not scope of the NSP. yet operational. • State level decision on salary scales leads • A marked lack of capacity at the State to inequity among states. Further, these Tuberculosis Training and Demonstration scales are often ill-aligned with market Center (STDC) perpetuates weak state and rates leading to lack of interested, qualied district/sub-district level capacity to applicants support the increasing programmatic • While some strides have been made in demands of the RNTCP to provide quality ensuring that adequate training of assurance, supervision, and monitoring.
36 Recommendations mechanism, in addition to the CMSS, to expedite procurement of drugs and Health Financing: diagnostics and reduce the excessively long 1. Complete a costing exercise through 2025 for lead times. the NSP 2017-25 as soon as possible. 2. Further integrate the NIKSHAY Aushadhi and a. In order to end TB by 2025, this exercise will NIKSHAY softwares to minimize duplication need to take into account all activities of efforts and inefciencies at the service including scale-up of relevant activities delivery level. required to reach this ambitious goal. a. Engage specic TA and technical partners b. Additionally, consider the commensurate to guide and support enhancements and nancial resources that may be required integration of NIKSHAY Aushadi. with increased PPE. 3. Prioritize conducting a needs assessment on, and 2. Obtain and regularly review TB expenditure upgrading of, the supply chain infrastructure estimates from public health expenditures and focusing on drug stores at all levels. national health accounts. 4. CTD should immediately (as soon as possible 3. Periodically measure and monitor the out-of- but no later than June 30, 2020) establish and pocket and catastrophic health expenditures disseminate guidelines with specic for TB. instructions on disposing and writing off of 4. Further strengthen coordination with NHA to anti-TB drugs to drug stores at all levels. be able to address nancing issues particularly 5. Research and implement a formalized on AB-PMJAY in-patient and potentially transportation mechanism that optimizes the outpatient packages for TB patients. supply chain management at the state level of 5. Build capacity at national and state level for drugs and other supplies to the transition from input- to output-based strategic district/subdistrict level. purchasing using TA from other partners, donors, and/or stakeholders as necessary. Financial Flow: 1. Disseminate a formal communication from Governance: MoHFW and RNTCP leadership mandating 1. Expedite the implementation of the the use of ePFMS at the state level and beyond governance structures described in the NSP at in order to systematize nancial reporting as all levels. This should include the introduction soon as possible. and use of TB elimination board(s) (see more 2. Mandate states to provide up-to-date under the Multisectoral Accountability and information on nancial contributions for the Engagement section). next scal year (FY) by the end of the nancial a. This should include effective monitoring year (April). and accountability frameworks. 3. NHM to appoint auditors in a timely fashion. 2. Rapidly employ methods of further Following which, there should be regular strengthening governance for efcient private submission of auditor’s reports and audited Ucs. sector engagement (see more under the Partnerships and Private Provider Engagement Human Resources: section). 1. Prioritize lling of existing vacant key positions (e.g. DR-TB, Lab, Accountant, Logistics & Procurement: Procurement, and PPM Coordinators) at all 1. Consider creating an alternative or back-up levels with qualied candidates.
37 2. Create and hire the additional required As a matter of utmost urgency, the JMM urges positions at all levels – national, state, district, the GoI to address HR shortcomings by and eld – to implement the expanded and updating RNTCP stafng requirements at all ambitious scope of the NSP. levels – national, state, district, and eld – (to 3. MoHFW leadership should engage state level include, but not limited to, quantity, skills mix, authorities to update salary and stafng salary scale, quality of in-service training of structures of RNTCP staff to accommodate the staff at all levels) by April 2020 and prioritizing implementation of activities. recruitments of positions at all levels by 4. Strengthen staff capacity at all levels by: December 2020. a. Performing training needs assessment at 2. There are unacceptable lag time delays in all levels (i.e., CTD and states). procurements. An alternative procurement mechanism must be developed while also b. Monitoring and reporting of CTD and state supporting the full deployment and utilization level implementation of approved CTD of NIKSHAY Aushadi to realize efciency gains and STDCs training plans. by June 30, 2020. c. Outsourcing of training as needed to 3. The continued increase in TB allocations by the ensure national coverage of quality Ministry of Finance are commended. In order training, to include the development and to meet the SDG target by 2025, it is important implementation of in-person and distance- to sustain, and in some cases continue to based training modalities. increase, funding levels for TB, as supported d. Including specic training on patient by accurate, robust costing exercise(s) of the centered care. This should consist of NSP from 2020 to 2025. It will be particularly building the capacity of staff at all levels to important to ensure that the most innovative provide counseling and responsive, aspects of the NSP are adequately funded. supportive care that is sensitive to the 4. The full transition of states to using PFMS (by principles of human rights and the April 2020) to expedite timely expenditure and persisting prevalence of gender, ethnic, auditing reporting to help improve budget and socioeconomic discrimination and execution and consecutively NSP stigma (see more in the Advocacy, implementation. Explore TA options offered Communication, and Community by various partners in improving PFMS Engagement and Ownership section). utilization. 5. Prioritize capacity building of the STDCs to execute their key functions. 2.1.4 Tuberculosis in Urban Populations a. Ensure that continued monitoring and The NSP recognizes urbanization in India as a evaluation of the STDCs is implemented in driver of the persisting TB epidemic noting that order to quickly course correct existing and epidemiologically, urban areas in the country are add new activities as needed. typically characterized by higher prevalence of TB b. Employ the use of TA as necessary to ensure with higher Annual Risk of TB infection (ARTI), and that STDCs are functioning effectively and rural areas are characterized conversely. The NSP efciently. acknowledges that ‘weak public health infrastructure and the crowding out effect’ in urban Key Messages areas coupled with weak referral and outreach 1. The absence of a well-prepared HR workforce severely limits access of the poor to urban health continues to be a major bottleneck in services in general and TB services in particular. The achieving the goal of a TB free India by 2025. NSP conrms that synergy of TB services with existing health service delivery in urban areas
38 through the Urban Health Mission will ensure provides an example for service delivery in optimal use of scarce resources and allow for complex and very large urban settings. integration. Several strategic interventions are This model should be customized for and identied within the NSP that include governance implemented in other similar contexts structure, planning, private sector engagement, across India. social mobilization, TB within urban primary care services, strengthening of referral services, active Challenges and Opportunities case nding in urban slums, involvement of While many great strides have been made in medical colleges, community-based surveillance addressing the unique challenges of TB in urban and collaboration and partnerships with other settings, some areas of challenge persist. stakeholders, especially convergence with other • Governance and Accountability: Health ministries and departments. departments within urban local bodies (cities with a population greater than Achievements 50,000 people, including all state- and The RNTCP has made remarkable progress in district-level headquarters) do not directly integrating TB control within health departments in report to the state health department. urban populations in the country. These departments are accountable to • The urban PHCs and Community Health their local bodies and the municipal Center (CHCs) now include ‘treatment commissioner of the corporation, who is centres’ that provide a dedicated space and also the chief executive supporting staff for TB service delivery. administration of that local body. • The programme leverages the ongoing Coordination should happen through the slum and vulnerability mapping (this is one state-level NHM leadership but this is not of ten thrust areas of the NHM across the happening across all states. country) for active case-nding. • Migration: Economic Survey, 2017 • The PPSA model for engaging the private revealed that inter-state migration is sector has been prioritized and rolled out in increasing. Economic circumstances and 48 cities. job seeking behaviors account for this rise • For urban settings, the programme in state-to-state mobility. National Sample provides dedicated HR to support patients Survey, 2007 -2008 (NSS, 2007-08) data and their treatment as well as to improve suggests that there were about 18.5 million community awareness of TB – one TBHV is inter-state migrants in 2011, of which 11 provided for every 100,000 population million were estimated to be in the 20 to and this adds to the general health staff 29-year age group. There is also evidence already provided through the National of rural to urban migration, with these Urban Health Mission (NUHM) to support migrants staying for longer periods in their service delivery in the urban PHCs and new location. The JMM teams reported that CHCs. migrant populations were an area of challenge and concern to the RNTCP • TB is also a part of the health and wellness across states, with a need for focused centres within NHM providing greater technical assistance and guidance on how visibility and access to TB services for to manage these groups. patients, communities and health providers. • The Mumbai model – a mega-city with The upsurge in migration and the absence of wide access to TB service delivery – affordable housing has resulted in an expansion of
39 slums in urban areas. It is estimated that 31 encouraged to invest in areas such as percent of India’s population now lives in urban education, poverty, health, gender areas and about 21 percent of the urban equality, and hunger. An additional population lives in slums. This translates to about amendment in 2019 requires companies 62 million people across India living in urban that do not fully spend their CSR funds to slums. Migrant labourers living in urban slums are disclose the reason(s) for non-spending a vulnerable and key sub-population that need and to carry forward any unused CSR funds education on, and access to, TB services. to the following year. In 2018, companies spent an estimated 47 percent more on Opportunities: CSR as compared to 2014-2015; • Capitalizing on multi-sectoral companies contributed about 7,536 crores engagement. Within the NUHM, the INR (1 billion USD) to CSR initiatives with Ministries of Housing and Urban Affairs the healthcare sector receiving about 25 (MHUA) and Women & Child Development percent. (MWCD) are working together to implement programs relating to wider Recommendations determinants of health like drinking water, Governance: sanitation, school education, etc. NHM 1. Continue to leverage NHM leadership at state leadership also provides oversight and level to engage the RNTCP within urban local coordination of the two sub-missions bodies at the national, state, and district level. National Rural Health Mission (NRHM) and 2. High-level advocacy to prioritize TB Free India NUHM. Prioritizing TB and using the within mega-city corporations at the existing platform of inter-ministerial commissioner and additional/joint collaboration would increase awareness of commissioner level ofces. Examples of TB and promote access to TB services. activities include: sensitization meetings; Additionally, there needs to be a concerted creation of platforms at different levels that effort to further expand the inter-ministerial include the corporation leadership; working network to facilitate cross-sectoral with the Ministry of Housing and Urban Affairs learning. Examples include: (1) working to help monitor progress of TB control, with the Ministry of Finance to coordinate followed by regular quarterly reviews as and potentially assume responsibility for appropriate. DBT to alleviate the programme’s bottlenecks and workload, and (2) 3. Intensify the frequency of convening of coordinating with the MHUA to assist in partners and scale of the implementation ensuring that the full continuum of TB response in the mega-cities with a special services are available to migrant focus on ensuring sufcient HR and nancial populations throughout the spectrum of allocations in proportion to the burden of their mobility. disease, and on strengthening epidemiological surveillance (including geo- • Identifying opportunities for, and making mapping) especially for high-burden drug- use of, Corporate Social Responsibility resistant TB (DR-TB) mega-cities. (CSR). Particularly in urban settings, there may be more possibilities for CSR. Following an amendment passed April Operational: 2014 to the Companies Act, 2013, India is 1. Consider expanding use of Aadhaar unique the world’s rst country to legislate identity numbers, perhaps integrating these as mandatory CSR contributions. As part of a unique patient identier within the NIKSHAY their CSR compliance, companies are system. This will allow for easier monitoring
40 and tracking of urban and migrant patients one of the pillars of WHO’s End TB Strategy, and is seen by various health providers. particularly pertinent for India, where millions of 2. Targeted interventions in slums and other new cases occur annually and more than 400,000 areas with vulnerable populations (mobile TB deaths occurred last year. Studies suggest that populations, homeless, etc.) to ensure access a signicant proportion of patients incur high out- to TB services, notication of TB patients, and of-pocket costs and even catastrophic expenditures treatment support for TB patients with special when seeking services, even where TB care is focus on transient or migratory patients. available free of charge. Enabling patient/people- 3. Expand guidelines on programmatic centered prevention and care continues to be an management of DR-TB (PMDT) to include enormous challenge for India as it seeks to end the guidelines on addressing migrant TB epidemic by 2025. This is an area that offers populations, and coordinate with the relevant tremendous opportunities to improve outcomes for ministries (including the MoUD), securing patients, their families and communities. Patient additional resources from interested donors as support systems are fundamental to integrated needed, to support the integration of TB patient-centered care. services for migrant populations in urban settings. TB continues to disproportionately affect key, 4. Extend contact management to workplaces vulnerable populations. For example, poverty- and non-relatives in shared housing to stricken and poor communities are more account for the particularly crowded nature of vulnerable to the disease because of greater workplaces and prevalence of shared housing exposure to TB infection in their communities, in urban areas. malnutrition, overcrowding, indoor air pollution. 5. Further promote and ensure adherence to Further, these communities also face geographic, airborne infection control (AIC) practices economic, educational, and/or cultural barriers to across the board but especially in urban not only accessing but also seeking and complying settings (e.g. in public transport). with care. Additionally, among these communities you nd marginalized populations like migrant 6. Promote policy change for mandatory/ workers, who often develop the disease working in voluntary leave for those patients who are locations distant from home and require special smear or culture positive in workplaces, attention, and tribal people, who often live in schools and colleges. Explore ways to remote and inaccessible locations. mitigate risks associated with discrimination, stigma, patient rights, etc. The key strategies outlined in the NSP on patient support systems are: Key Messages • Implementation of TB treatment services in Urban populations are large, complex, and require health facilities and communities. targeted interventions and multisectoral - Develop a patient-centered plan that coordination in order to successfully end the TB includes: i) initial and frequent follow up epidemic. With the rise of inter- and intra-state counseling of patient and family mobility and movement, particular attention must members ii) supervision of treatment be placed to address the specic needs and through treatment supporters iii) locally challenges posed by migrant and vulnerable managed nutrition support iv) screening populations; these will often require unique, and for adverse reactions, treatment innovative interventions. interruptions, co morbidity management v) linkages to social 2.1.5 Patient Support Systems support schemes Integrated patient-centered care and prevention is - Decentralization of treatment services
41 through information and accommodative system to ensure payments to communication technologies (ICT) maximum number of people, NIKSHAY was support. adapted to address rising challenges which - Extend patient support services for included some instances of misappropriation patients in private sector which are the (estimated at less than one percent). Some of these same as for patients in the public sector updates included tagging each beneciary to a mentioned unique bank account number, and moving from • Regular and long term follow up and facility to individual identiers for program staff. rehabilitation of all treated TB patients Achievements The strategies above refer to the educational needs DBT: of the patients and the need for supportive • The launch of DBTs is ground breaking supervision. Since the last JMM in 2015, the issue because it enables direct payments to TB of nutritional support in India’s patients has gained patients, irrespective of any identity or traction. In 2017, the RNTCP released a Guidance other requirements. The consecutive Document for Nutritional Care and Support for extension to tribal populations, treatment patients with active tuberculosis in India, which supporters and private providers is recommends that a nutritious diet, adequate in commendable. calories and proteins, is required as an adjunct to the therapy of TB patients in India. In 2018, the GoI • In the rst year, more than 2 million launched a DBT scheme – the NIKSHAY Poshan patients received at least one instalment of Yojana, and provided a monthly benet of Rs. 500 incentives, equating to about 55 million to enable both private and public sector TB patients USD being dispersed. to afford a nutritious diet. The RNTCP also has • A basic deduplication module, all four NPY implemented ICT based adherence monitoring (99 payments modules, tribal scheme, Directly Observed Treatment, Short-course treatment supporter, and payment to (99DOTS)) in selected states and locations, and private providers were developed and made a call center operational. These are positive deployed in NIKSHAY. These have since steps. Further, in 2018, the RNTCP released the been veried by the Independent results of a study on State Initiatives on Patient Verication Agency (IVA) as a part of the Support Systems for TB elimination in India, which World Bank credit to the TB program. documents the various initiatives of cash assistance, nutritional support, and livelihood assistance being Adherence Support Systems: implemented in different states in India. This is also • Adherence support system have been part of the Multisectoral Engagement Framework of integrated into NIKSHAY with a single the RNTCP. unied interface for rell monitoring and different digital adherence technologies For the purposes of this section, the JMM chose to (ICT), including 99DOTS, Medication Event focus on DBTs and adherence support systems. As Reminder Monitors (MERMs), Operation background, DBTs for patients were rst initiated in ASHA (OpASHA) and virtual/video directly April 2018 via NIKSHAY version 1. Due to early observed treatment (VDOT). challenges, DBT payments were incorporated into a • Integrated Digital Adherence Technologies NIKSHAY version 2 launched in September 2018. (IDAT) tools have been deployed in key sites This is the rst time that direct payments to patient across the country to understand bank accounts were initiated, and there has been acceptability and implementation needs. an initial learning phase. Initially built as an
42 Challenges and Opportunities differences in initial and subsequent payments across public and private sectors DBT: (Table 6). Delays in payment from the time • Timeliness and coverage: There are the patient is notied is also a challenge.
Table 6: Shows the DBT cascade (Patients notied from January through June 2019).
Drug Sensitive TB Public Private Bank details available of those notied 83% 43% Bank details validated of those notied 68% 34% 1st Incentive paid of those notied 52% 22% Drug Resistant TB Public Private Bank details available of those notied 82% 80% Bank details validated of those notied 58% 58% 1st Incentive paid of those notied 50% 49%
• Equity: Access to benets in remote and comprehensive and do not include tribal areas remains a challenge (no bank information on gender, ethnic, and accounts, cooperative banks etc.). socioeconomic discrimination and • Adequacy: It is not clear if the amount stigma. offered for nutritional and nancial support • Nutritional assessment, counseling and via NPY is adequate. support: • Impact on core function of patient - Persisting high prevalence of severe supervision in RNTCP: The STS is unable to undernutrition and related spend adequate time focusing on core comorbidities in TB patients, particularly patient supervision functions due to drug-sensitive TB (DS- TB), requires competing responsibilities on supporting immediate further attention and action - enrolment for DBT. - such as use of body mass index (BMI) to identify those at high risk for drug- Adherence Support Systems: induced hepatotoxicity and death, and • Lack of adequate counseling for patients in need of specic support for nutritional with drug-susceptible tuberculosis needs recovery. strengthening. • Patient supervision for adherence: - Currently, per RNTCP mandate, only NIKSHAY is currently not used for entering MDR-TB receive the information on the rell monitoring and dosing disease treatment and prevention by a implementation data. The data is currently counselor. entered on treatment cards by health care workers, resulting in the need for paper - Patients with drug-susceptible documents and treatment cards. tuberculosis do not have access to an Additionally, limited information on patient assured system of patient education adherence for patients notied by private supplemented by patient information sector providers. material on disease treatment and prevention during the course of • Deployment of digital adherence treatment. technologies: With the exception of the deployment of 99DOTS in Gujarat, there • Current counseling practices are not has been limited deployment of ICT and
43 IDAT tools. A dashboard showing to inform revisions in payment. treatment adherence digital options has 4. Evaluate the use of program staff involvement also been available in other states, and in DBT (e.g., STS) by: should enable comparative adherence on a. Reviewing ndings of the recently initiated multiple technologies for a number of TB time motion studies for different program patients linked. Early data suggest that personnel (STS); patients can greatly benet from innovative adherence support options and switching b. Explore alternative or outsourced agencies protocols and support to take medicines. options to address the observed gaps. • Lack of disability assessments at the end of TB treatment and linkage to social welfare Adherence Support systems: schemes. Many patients with extensive 1. Enabling treatment adherence: pulmonary tuberculosis are unable to a. Provide TB patient counselling support to all return to their previous occupations patients and families (in their local languages) because of extensive lung damage. Some at the point of diagnosis and in the continuum types of extrapulmonary TB can also be of care. Counselling should be human rights- disabling. based and include information on disease prevention, treatment and adherence, and Recommendations social benets (including DBT) as well as The JMM team has proposed recommendations information on gender, ethnic, and based on the challenges faced during the initial roll socioeconomic discrimination and stigma out period of the past 18 months. associated with TB. i. Capacity of staff at all levels must be built to DBT (via NPY): accomplish this level of patient support. 1. Patient (Equity and Access): Ensure timeliness b. Strengthen community-based patient of rst and subsequent payments to ensure support by the health system (ASHA, MPW availability of monies to patients who need it and STS) supplemented with ICT and IDAT. the most (vulnerable populations); when they Establish and link these with other need it the most (timeliness). Do not delay community patient groups and blended initiation of treatment for the purpose of DBT ICT adherence support systems. Convene requirements. a national meeting on deploying 2. Recommended NIKSHAY improvements: appropriate adherence support that are a. Consider integrating the use of Aadhaar based on patient choices/preferences and authentication, but do not exclude in its in-line with local needs. absence. c. Optimize the use of NIKSHAY to monitor b. Initiate centralized DBT payments at the rell and follow-up review adherence national level concomitant with measures information. for real-time entries. d. Patient nutritional assessments should be c. I m p l e m e n t p r a c t i c e s t o p r o v i d e conducted and dietary counseling transparency and communication to modules (e.g. mobile apps58 ) consistent patients around payments. with WHO Guidelines on Nutritional care 3. Deploy patient cost study to assess and and support for patients with tuberculosis address out-of-pocket expenses. should be made available to healthcare Continuously monitor and review patient and workers so that they are educated on the nutritional outcomes following DBT payments link between nutrition and TB, and can
Like the N-TB app (Android/IOS).
44 inform patients on best practices for that move within the health system. The nutrition recovery. RNTCP should consider a patient transfer 2. Social Benets: module which will provide seamless access a. States should be encouraged to provide to treatment initiation. social benets and nutritional support i. This is particularly important in the case beyond NPY (Hybrid model) in keeping of migrant workers who require to be with the current best practice document transferred quickly (see section on on State Initiatives on Patient Support Tuberculosis in Urban Populations). Systems for TB in India. b. Develop task lists in NIKSHAY for linking, i. Explore other options for nutritional tracking pediatric contacts with pop-up support delivery including PDS. messages (see section on Childhood b. The MoHFW should provide access to Tuberculosis). comprehensive inpatient care without cost c. Consider post-treatment follow-up. for all TB patients under Ayushman Bharat, and continue its work towards outpatient Key Messages packages. 1. In order to end TB by 2025, there needs to be a c. Implement formal patient disability comprehensive patient-centered care and assessments at the end of TB treatment and support that prioritizes patient literacy, risk link patients to social welfare schemes as assessment, community-based adherence necessary. support tools, and nutrition (DBT + direct 3. Patient Screening: nutritional support). a. With a view to reducing mortality, 2. DBT is an important initiative with potential to implement a triage tool for severity reduce catastrophic costs and improve patient assessment to identify severely ill patients outcomes, but its implementation should be and support their access to care which is redesigned and realigned to enable currently limited because of paucity of beds programme staff to carry out their core for TB at the district. function in core patient support and care activities. i. A triage tool based on nutritional status, vital signs and presence of anemia has 3. Patients need disability assessment and been suggested in the RNTCP rehabilitative services at the end of treatment, document on nutritional care and to enable positive long-term outcomes for support. patients and their families. b. Implement a differentiated care approach for patients with comorbidities and 2.1.6 Community Engagement, complications to improve treatment Advocacy, Communication, and Social outcomes (see sections on Comorbidities Mobilization and Childhood Tuberculosis). The designated JMM group reviewed the progress c. Implement simple systematic relapse in implementation of the strategic interventions surveillance via phone calls made to listed under the chapter on Advocacy, patient cohorts at regular intervals to Communication, and Social Mobilization in the ascertain if relapse has taken place over a NSP, 2017-2025. It is apparent that a massive two-year period. social movement is urgently required to achieve 4. NIKSHAY Improvements: Prime Minister Modi’s bold, unprecedented, and a. Develop a patient transfer module to ambitious target of ending TB by 2025. An ensure initiation and tracking of patients important rst step towards this will be the effective
45 integration of this thematic area within all the four recognized, and there is better community pillars of the NSP: Detect, Treat, Prevent, and Build. engagement in TB prevention and care. - A differentiated approach in engaging Below are the key messages and ndings, including communities and key population groups achievements and persisting challenges, and will need to be implemented, including actionable recommendations, from this mission’s in active case nding campaigns. eld observations, and inclusive team discussions. - Community engagement needs to move to the next level of community Achievements: ownership. • Political Commitment – At the highest level, the Prime Minister’s Ofce is actively Challenges and Opportunities leading and monitoring the ght to end TB • Political Commitment – The full potential of in India. all elected representatives, including MPs, - The domestic budget for the RNTCP has MLAs, and Gram Panchayat members, is more than tripled with this commitment. yet to be realized to capitalize on Prime • State initiatives – The commitments by Minister Modi’s leadership and several States for TB Free status, combined commitment (see Multisectoral with national efforts to end TB, have been Engagement and Accountability section). widely publicized by the leadership in some • State initiatives – Most states have not been states. The creation of state and district able to set up accountability mechanisms elimination boards in a few states for ending TB (see Multisectoral establishes an accountability system for this Engagement and Accountability section). goal (e.g., in Kerala). • TB Forums – Forums have not been made • TB forums – The structure of TB Forums is functional at all intended levels. dened for national, state, and district • Communications– Continued engagement levels. with media and ongoing campaigning - TB forums need to be supported to measures. ensure that they are functional and - Implementation of communication effective. campaigns needs to be ongoing, rather • Communications – There is improvement than in short, infrequent, bursts, and in the content of communication material effective monitoring and impact on TB with campaigns bearing high-prole evaluation needs to inuence new public faces (e.g., Bollywood celebrity communication strategies and content. Amitabh Bachchan). - Engagement of media has been • TB Champions – TB survivors and reactive or patchy, and needs to become champions are playing increasingly proactive. important roles in the TB response. - High impact campaigns are largely - Building the capacity of TB survivors to operated from Central level and often become champions, and of TB affected not adequately tickled and adapted at communities to play a larger role in State and peripheral level. decision making and patient support, is • Community engagement – Challenges in the next step in actualizing the effective community engagement continue leadership potential of these crucial to persist; specically, there is a lack of actors. rights-based approaches and legal • Community engagement – The importance interventions, and untapped potential in of engaging the community is being community monitoring of service quality.
46 • Gender and stigma continue to be huge Development Fund in tribal areas); and issues. d. Ensuring participation of the Panchayati • Human Resources – There continues to be Raj Institutions (PRI) in district and sub- limited capacity at district, state, and district level TB Forums. national levels to effectively implement 3. Implement, monitor and evaluate the impact community engagement, advocacy and of communication campaigns by: communication activities. a. Following the principles of rights-based, multilingual, culturally appropriate, age- Recommendations: appropriate, and gender sensitive 1. Implement TB Forums at the national, state communication; and and district levels, and ensure their b. Outsourcing the design, implementation, effectiveness by: and evaluation of communication a. Conducting regular meetings (e.g., campaigns to dedicated and professional quarterly) aimed at identifying problems in creative agencies. need of solutions and providing updates on 4. Address the persisting gender gap by: progress made; a. Ensuring equitable participation of women b. Ensuring community ownership by in RNTCP TB responses and decision designating civil society co-chairs along making, including in TB Forums; and with the government ofcials; b. Rapidly reviewing and implementing the c. Ensuring diversity in the TB forums in terms gender response framework. of gender and key populations; 5. Eliminate stigma and discrimination related to d. Empowering forums to contribute to TB by: program quality improvement and a. Developing a comprehensive strategy to assurance through ongoing capacity understand, mitigate, and eliminate building of their members; stigma and discrimination; and e. Monitoring governance, actions, and b. Ensuring continued measuring and outcomes; monitoring of stigma reduction. f. Ensuring adequate funding; and 6. Strengthen community mobilization and g. Learning from, and adapting, initiatives of ownership of TB responses by: proactive states/districts across India a. Empowering communities through making progress towards TB elimination participatory trainings on treatment (e.g., Kerala). literacy, rights, counselling, peer support, 2. Engage in high-level advocacy with the and funding; National Parliament and State Assemblies b. Providing communities with tools for (e.g., Telangana) by: monitoring services (e.g., Apps); a. Introducing TB laws based on the principles c. Addressing specic needs of key of human rights; populations (e.g., migrants, tribal b. Establishing, where not yet implemented, a populations, children) using vulnerability TB Committee/Sub-committee under the mapping techniques; Health Committee; d. Linking community engagement to all four c. Encouraging Members of Parliament (MP) pillars of the NSP (Detect, Treat, Prevent & to review TB as a priority in their Build) and by monitoring the outcomes; constituencies, and to consider the use of e. Preparing communities for active or MP funds and available resources to enhanced case nding; address local needs (e.g., District Mineral
47 f. Learning and scaling up best practices population groups, to meaningfully contribute from other programs (e.g., Polio, HIV, to advocacy, planning, implementation, and others); and monitoring of the TB response; g. Developing and including an indicator on 2. Invest in establishing TB Forums at all levels, community engagement in State and including sub-districts, making them effective District Score Cards. agents for quality improvement and assurance 7. Address human resource gaps and develop along the care continuum; the capacity of RNTCP staff: 3. Conduct round-the-year communication a. Speed up recruitment of planned social campaigns that are strategically designed by scientists and community mobilizers at outsourced expert agencies to inuence national, state and district levels; positive behaviors and improved awareness; b. Build capacity of staff to effectively engage 4. Systematically align towards promotion and with communities and key population protection of human rights, gender equity, and groups on issues of stigma, rights, age and provision of differentiated care for key gender; populations; c. Build capacity of staff to collect and 5. Eliminate stigma and discrimination towards respond to feedback from community persons with or affected by TB, and towards monitoring of services; their families; and d. Outsource activities to NGOs under 6. Advocate for a rights-based TB Law to be partnership guidelines as needed; passed by Parliament, and for the e. Obtain technical assistance to augment establishment of a Parliamentary Sub- and compliment the technical capacity committee on TB. available at the national, state, and district levels; and. 2.1.7 Research and Innovation f. Publish all RNTCP guidelines and From review of the NSP 2017-25, the importance of frameworks through an open web re-invigorating TB research in India particularly for consultation to allow for input from all optimizing services, informing policy, and stakeholders. developing new tools is clearly evident. For many years, TB research was largely conned to major Key Messages: studies by national institutes, research supported by national and state networks, and research funded Create and foster a nation-wide social movement, by external donors. Over the past 3 years, the similar or bigger to the ‘Swachh Bharat’ campaign landscape of TB research has substantially shifted; in India with the same level of resources and details Indian TB researchers have more funding in place, to end TB by doing the following: opportunities that ever before (see Table 759 for an 1. Empower communities, especially key illustrative list of sources for funding research).
Table 7: An illustrative list of potential sources of funding for TB research in India grouped nationally and internationally. National Sources (e.g. national and state governments, local organizations, etc.) RNTCP (CTD, State TB Cell, OR committees, NTI) ICMR—India TB Research Consortium ICMR— Task Force studies, Intra-mural funds
59This table was authored by the writers of this section and is meant to be illustrative and not exhaustive in nature.
48 Dept of Biotechnology/ BIRAC Dept of Science and Technology- CSIR State Health Budgets Intra-mural Funds of National Institutes (AIIMS, PGIMER etc.,) Indian Institute of Technology (Internal Funds) Ministry of Tribal Affairs (MoTA)
International Sources WHO The Union Global Fund FIND-India USAID UNITAID Bill and Melinda Gates Foundation India Health Fund (Tata Foundation) NIH Pharmaceutical Companies (J&J, Eli Lilly) US-CDC Wellcome Trust TB- REACH (Stop TB Partnership)
One of the most noteworthy changes in the Indian institutional strengths. With a budget of more than TB research landscape is the establishment of the Rs 120 Crore and multiple studies currently India TB Research Consortium (ITRC) as an underway, the ITRC has been increasingly active extramural program of the ICMR. This since its inception. domestically-funded, extramural program was • The NSP details some very specic research originally envisioned as an independent entity, but activities of which many have been ultimately remained within the Department of completed or are currently underway Health Research in order to capitalize on (Table 8).
Table 8: Status of Research Activities Proposed in the NSP, 2017-2025 Source: Multiple Proposed Activity Status (as of Nov. 2019) Implementation research for active case nding among Incomplete: massive ACF activities but key populations little research being done, and what is done is not yet informing policy. Implementation research for demonstration of resource Incomplete optimization for implementation of newer diagnostic algorithms
Conduct operational research to determine the Planned: by ITRC, 3 studies pending to feasibility of chemoprophylaxis / preventive therapy in start different risk groups (contacts of TB / DR-TB, etc.)
Initiate testing/evaluation of at least 3 new diagnostic/ Started: ITRC - Truenat/AG, culture in prognostic tests (preferably of Indian origin) for bottle; C-Tb diagnosis of TB, DR-TB & latent TB
49 Initiate pilot of at least 3 novel regimens for drug- DSTB: 2HRZC/2HRE, High dose RIF, sensitive and drug-resistant TB in through and adjunctive Tx. Implementation research for those already piloted XDRTB: BEAT TB (9BDLzC) elsewhere and through clinical trials for completely novel regimens MDR: 9BCLzLv (regimen might change). Stream 2 under RCT. (Adaptive trial)
Initiate testing of at least 1 candidate vaccine in Indian Started: VPM0001/Aso1 vs Mw population Placebo in contacts; VPM0001 in cases.
Initiate at least one large scale genetic susceptibility Not Started study, preferably from the same sample of that of TB prevalence survey
Initiate a TB elimination project through implementation Started: Kerala, Ernakulam, Idduki, research in at least 3 districts in the country Chennai
Perform. feasibility studies for uptake of new tools Started: TrueNat, Xpert including replacement of smear microscopy with molecular diagnostic methods at the Microscopy level
Strengthen Operational Research through an Not started but proposed: National OR institutional mechanism at NTI committee and TOR; National Research Center.
Perform Operations Research for feasibility of Not Started introduction and scale up of IGRA
Perform operational research on TB/DM to determine Not Started best treatment strategies, regimens and durations.
Build capacity for tuberculin production/identify new Started: C-Tb tuberculin or sub-unit Antigen for TST
In order to effectively reach the diverse populations remote populations, these innovations have across the country, continued innovation and remained largely compartmentalized and hidden adaptation are key. This means moving beyond with very limited scale-up or uptake into broader available NSP and technical guidelines. In other policy and practice. words, the program itself must remain uid and dynamic at all levels. Flexibility and innovation In the following sections, the JMM authors grouped have been encouraged at the national level, but program challenges and opportunities, and appear to be lacking at the local-, grassroot-level. recommendations under ve broad research and While there have been some incredible micro-level innovation categories: institutional structure and innovations as local programmes struggle to capacity; operational research (OR); case nding implement new policies and reach isolated and and detection; treatment; and prevention.
50 Achievements completed vulnerability mapping as a baseline analysis for potential activities. Institutional Structure and Capacity: • Interesting and promising studies on • Positive shift in TB Research landscape with vaccines and prevention are currently an increase in potential funding sources. underway. • NSP outlines specic research activities, - RATION study: a randomized control and many of these activities have been trial (RCT) that is using food as vaccine initiated and are ongoing. among household contacts; and • Some States (e.g. Gujarat and Karnataka) - Two multisite vaccine RCTs. have been able to articulate state-level needs and target OR activities against Challenges and Opportunities them. Institutional Structure and Capacity: Operational Research: • Persisting administrative barriers stie • National-level priorities have been research and scale-up of innovations. identied and updated in 2017 by the ITRC • With the launch of new activities and for OR. initiatives (e.g., PPE, DBT, ACF, contact tracing, NIKSHAY), the capacity and Case Finding and Detection: management ability of the RNTCP appears • CB-NAAT has been scaled-up to district- strained. Integration of new tools requires level facilities. a degree of RNTCP-led implementation science and this is not happening. • In 2018-2019, nationwide ACF campaigns were conducted. For the most • Innovations at the national level are part, these efforts were community-led difcult to recognize, capture and screenings of geographical areas that integrate into the program. At the local public healthcare workers perceived as level innovations are not adequately containing the largest number of high-risk scaled-up or included into broader policy individuals. and practice. • A dramatic increase in the number of TB • While collaborations have been proposed notications from the private sector. with Brazil, Russia, India, China and South Africa (BRICS) and six meetings have been • After a decades long gap in surveillance held in the last two years, no clear plan knowledge, the First the First National Anti- forward has been proposed or publicized Tuberculosis Drug Resistance Survey as a result of these efforts. (NDRS) nally claried the nature of anti-TB drug resistance in India, for rst- and • The inception of a National Research Cell second-line drugs. within the National Technical Institute was initially proposed ten years ago but it has Treatment: yet to be approved and launched. This Cell is intended as a solution to the • The RNTCP programme has nally shifted perpetual challenge of securing to daily dosing for the basic TB regimen no operational research (OR) funding, lack of longer insisting on universal use of labor- capacity for OR and dissemination and use intensive DOT. of ndings to inform updated evidence- based policies.
Prevention: • There have been expressions of interest in • Some states (e.g., Kerala, Chennai) have the creation of an open data system to
51 encourage researchers to mine and utilize detection and the need to aggressively the wealth of existing data generated by reduce transmission dwarfs the case RNTCP and Partner agencies. nding and detection accomplishments thus far. Operational Research: • Inadequate tools and strategies in place to • Lack of state-level OR focal points with the efciently and effectively screen high-risk capacity for OR planning, training, and populations at scale. The diagnostics funds to implement programmatically- currently being developed and/or relevant OR. In many cases, eld visit evaluated in India are not likely to meet the teams observed that this responsibility was country’s needs. left to a designated ofcer, the State or • Lessons learned and best practices from Zonal OR chairmen, and consultant, and the nationwide, large-scale ACF activities there were limited capacity building have not yet been synthesized, reviewed, or efforts. ultimately feedbacked into policy • From the materials reviewed and recommendations. observations made by the team, limited • Even with the availability of new and investments and progress made on the innovative case-nding tools (molecular national-level OR priorities particularly in: diagnostics, CDR, AI algorithms, C-Tb), RNTCP management, addressing the insensitive smear microscopy continues to socioeconomic impact and catastrophic serve as the primary diagnostic test for costs of TB and integration into universal most cases of presumptive TB. health coverage schemes (e.g., State • Lack of capacity in detection of Isoniazid insurance programs). (H) resistance at the point-of-care level • While there are national-level OR persists. As a result, only a small priorities, it is important that priorities are proportion of the total estimated H- identied at the state-level. Field visit resistant TB has been detected and treated. teams observed that, in many cases, states - Similarly, only a small portion of sporadically, if at all, attempted to clearly children and extrapulmonary TB articulate needs and match OR priorities patients have been successfully respectively. screened for drug resistance. • The incredible potential of the electronic • While private sector notication has data system, NIKSHAY, remains largely increased, the program has not yet untapped. For example, OR could help internalized those notications or reached address the continued widespread gaps in those patients with comprehensive public data and its quality and lack of health actions. This results in the lack of participation by general health staff. equitable access to care and services for - Secondary analysis of program data is private sector TB patients. limited to annual reporting. - While vast data streams are converging Treatment: into NIKSHAY, this wealth of information • Ongoing clinical trials offer promising is largely inaccessible to researchers. pathways to incrementally improved treatment for extensively drug-resistant TB Case Finding and Detection: (XDR-TB) and rifampicin-resistant TB (RR- TB), but those trials will not yield a single • The extremely wide gap between early case transformative regimen for all patients
52 detected with RR-TB. The NDRS articulated (LTBI) (i.e., household contacts under 6 a denominator for different forms of anti- years of age and PLHIV). TB drug resistance. • Continued uncertainty on the strategy to • Persisting challenges in treatment use for any expansion (e.g., test and treat monitoring and adherence, especially for vs. just treat), and new globally approved TB patients notied by private sector regimens (e.g., 3HP) are pending providers. There is an inability to reach the additional clinical research in India which privately treated TB patients with program- may further delay introduction. procured drugs, and effective • AIC remains an issue in health care management of RR-TB and other drug facilities despite the completion of several resistance. pilots and the roll out of national • While many options both physical and guidelines. Part of the challenge is that digital (e.g., 99DOTS, call center intrinsic managerial nature of AIC support, ICT, IDAT, MERM) were interventions but another other issue is the provided by the programme, these have lack of suitable tools (e.g., the low cost and not been made available to staff and maintenance of LED ultraviolet air patients for use. germicidal irradiation (UGVI) xture made • There is a gap in implementation research in India) for scale-up mostly. on the programmatic deployment of new • Lack of linkage between vulnerability regimens. studies and surveys to prevention efforts. • Uptake of new regimens at the eld-level is lower than expected. This issue remains to Recommendations be systematically evaluated because it has Instructional Structure and Capacity: not yet been adequately addressed by 1. Improve ITRC-RNTCP linkage: reexive training and advocacy alone. a. Articulate India’s TB elimination needs with • Ongoing challenges in both the design and specic TPP to ITRC. adequacy of the subsidy (for nutritional support) are present in the DBT program b. Refresh the ITRC pipeline with RNTCP- (see the sections on Health Systems driven needs, including cessation of things Strengthening and Patient Support that are not considered a critical path to TB Systems). Implementation deciency in elimination. private sector TB patients is also an issue. c. Consider creating a dedicated technical cell and/or set of program ofcers to Prevention: support researchers through administrative processes, along with terms of reference to • TB prevention as a recognized and encourage and facilitate translation of intentional programmatic activity has yet to ndings into evidence-informed policies. launch at scale. Intrinsic challenges in the detection of incipient disease limit the value 2. Leverage the Model Rural Health Research unit of “targeted testing and treatment of latent (MRHRU) for intensied TB surveillance. There TB infection,'' as immunoreactivity (via the are 18 such units across the country under the TB skin test (TST), interferon gamma Department of Health Research. These units release assay (IGRA)) remains a poor have dedicated staff who are engaged in predictor of risk of disease progression. research based on local needs. These MRHRUs can serve as surveillance centers for • Low uptake of chemoprophylaxis, even TB at no additional cost. among the groups who are recommended for empiric treatment of latent TB infection
53 Operational Research: 8. Develop approaches and rapidly scale-up 3. Update RNTCP OR agenda with genuine digital CXR screening by leveraging AI tools. priorities, and issue calls for proposals against 9. Develop and deploy decentralized complete top needs. Clarify ownership on driving rapid DST (e.g., next-generation sequencing operational research and implementation (NGS), etc.). science, as there is overlap between ITRC and the RNTCP OR mechanisms. Perhaps ITRC is Treatment: best for complex studies/managing 10. Urgently fast-track trials for simpler, safer, prospective surveillance sites where shorter regimens for all forms of TB. Consider interventions can be embedded and quickly the following starting with RR-TB as the model tested. RNTCP ownership may be and employing an adaptive and pragmatic advantageous for state/local OR to identify design that includes pediatrics, patients with limitations in the cascade of diagnosis and comorbidities etc. care, and improve program management/ 11. Develop and validate a non-sputum biologic efciency. marker of cure for use instead of time/dosing 4. Empower the NTI based National Research for clinical trials, and adapt for program use. Cell to help manage the knowledge needs for 12. Evaluate the reasons for low uptake of newer TB elimination with an independent and fully- drugs/regimens and identify measures to staffed secretariat equipped to: rectify them. a. Conduct innovation identication 13. Identify and assess patient-centric approaches evaluations and feedback into policy; to improve treatment adherence by b. Provide TA to States on OR needs and introducing new digital treatment support priorities and calls for proposals; tools and by building on the experience of the c. Build OR capacity development for rst-generation products that failed to scale researchers; and (see section on Patient Support System). d. Create an IT platform for transparent processes and funding ows. Prevention: 14. Improve the utility of vulnerability mapping by Case Finding and Detection researching best methods and then scaling up 5. Make a concerted national effort to develop intervention efforts and deploy a TB triage and screening test by 15. Establish an optimal ACF and preventive investing in both research and evaluation of treatment strategy inclusive of efcacy/ already available global candidates. This is effectiveness of treatment, durability of considered the highest priority research need. protection and models on impact of 6. Conduct formative evaluation(s) of ACF intervention on TB disease and deaths at local campaigns, and develop differentiated level by developing surveillance sites in high guidelines. These guidelines should at transmission settings (large community minimum include information on when to cohorts) and then following them prospectively conduct activities, whom to target, how to (without treatment) to identify prole(s) most screen in different groups and/or settings, and predictive of disease. These cohorts may then when/where not to use ACF. also be used for intervention studies. 7. Optimize the diagnostic algorithm currently 16. Evaluate the predictive value of incipient recommended by public sector providers disease (C-TB, signatures of risk and across all sectors. progression/ outcomes). 17. Evaluate relative efcacy of AIC options, and
54 develop better indigenous low cost UVGI • The Union xtures. • Bill and Melinda Gates Foundation (BMGF) 18. Fast-track research on safe and effective • Stop-TB-Partnership (including through the vaccines and contribute to early adoption. GDF and TBREACH • GF (e.g. JEET project implemented with Key Messages CHRI, CHAI, and FIND) The JMM recommends urgently revising the ITRC • World Bank pipeline to RNTCP’s needs; evaluating the current TB • Parliamentarian Forum - GCAT elimination efforts at the state- and district/sub- • Community Empowerment organizations district-level (e.g., Kerala, TB-free cities) to inform (e.g. GCTB SATB, GHS, etc.) scale-up of best practices; directly supporting OR to address gaps and challenges in the private sector • Support for Research through Niti Aayog, cascade of care (e.g. detection, adherence); CDC, Wadhwani AI, TISS, IIPH etc. improving the DBT and social support package(s) and their processes, and then monitoring economic Achievements impact, catastrophic costs, and cost-effectiveness to • An expansive network of technical experts identify priority areas for investment and allocation of supported by domestic and donor resources; and investing in identifying a scalable resources with a vision to continue model for UHC integration and TB package in AB- expansion PMJAY. Additionally, developing and rapidly • To date, all of the recommendations from deploying a TB triage or screening test(s) and a non- the WHO technical support network (TSN) sputum point-of-care diagnostic test to be used in assessment report have been effective ACF and prevention strategies will be critical implemented. These changes include the if India is to meet the Prime Minister’s commitment to expansion of the consultants network, an reach the 2030 SDG target by 2025. increase from 80 to 148 technical consultants are in place, including 26 at 2.1.8 Technical Assistance to End CTD and 8 regional consultants, and Tuberculosis in India transition to domestic funding of the TSN. India is enriched with a large pool of technical TB • There is also an appetite for focusing experts as is evident by the fact that more than 60 support to priority technical areas (e.g., percent of the countries globally have received TA PPE, DR-TB, TB surveillance) by using the from an Indian national for their TB programs at new regional consultants in conjunction least once. A variety of technical committees on with the continued TA from WHO and other various thematic areas function at the national level development partners. provide the RNTCP with policy and operational guidance. The program is also receiving TA through Challenges and Opportunities a variety of mechanisms and sources (see • Continued space challenges and 60 illustrative list below). constraints at the CTD. • National Institutions • There are additional areas in need of • TB Association of India technical-managerial assistance beyond • Medical Colleges what the network has offered. • WHO (e.g. RNTCP TA project) • USAID partners (including Karnataka Recommendations Health Promotion Trust, WHP, REACH, 1. Considering the magnitude of the growing SHOPS+, THALI, Challenge TB, FIND) operations and needs, technical assistance
60This is meant to be an illustrative list that may not be exhaustive of all current, past, and future TA sources.
55 needs to continue to be expanded and scaled- 4. C o n s i d e r p r o v i d i n g TA b e y o n d t h e up geographically and in technical areas with RNTCP/CTD to strengthen PPM, universal additional continued resources to increase health coverage, output-based contracting, coverage in order to end TB by 2025. and include other Ministries (e.g., Ministries of 2. Provide infrastructural support (e.g., ofce Information Technology, Planning, Urban space) to accommodate the present and future Development, etc.) to help them support TB expansion of the network. elimination by 2025. a. With the proposed expansion, space will 5. Development and deployment of an likely continue to be a challenge in national information system that compiles all available and sub-national units. This issue needs to technical assistance experts (ensuring to be addressed proactively. include areas of particular expertise). This 3. Ensure that existing and expanded TA remains mechanism could serve as a pool of short- and focused on relevant thematic areas and has long-term national and international the capacity to address new themes as they consultants that would allow the TB program to emerge. quickly respond to TA requests. Partners providing TA support could facilitate this a. The JMM team recognizes that WHO activity. contributes value in TA based on their core competencies, role, and experiences. A list Key Messages of emerging or additional thematic areas has been identied by JMM that will need The JMM team applauds the efforts made by the technical-managerial assistance and GoI in ensuring the availability and use of TA. By should leverage expertise from WHO and implementing suggested recommendations (i.e. other development partners to facilitate expansion and domestic funding) for strengthening smooth implementation. This list includes: the TSN, an important step has been made in (more information on each area listed advancing effort to a TB free India. The next step is below may be found in other sections of the to ensure that TA is focused on the emerging needs report). and technical areas of the program (see list above for list of emerging needs). To sum up, in order to i. Epidemiological intelligence units (at all levels) end TB by 2025, the JMM recommends the ii. Prevention expansion, both geographically and technically, of iii. DBT, nance, project implementation plan technical assistance that is supported by sustained (PIP) preparation (state- and district-levels additional resources. iv. Community mobilization v. Addressing Social determinants, e.g. 2.2 Prevent nutrition/housing etc. 2.2.1 Preventive Services vi. Operational/Implementation Research The NSP 2017-25 has dedicated an entire section vii. Quality of care for TB patients including on TB preventive services and clearly outlines adherence monitoring, post treatment strategies for its expansion including: monitoring and care, social support, etc. • scale-up of TB preventive therapy (TPT) viii.Stigma and discrimination among contacts of TB patients; ix. TB in urban populations (particularly in • addressing social determinants of TB slums and migrant workers) through multisectoral collaboration; and x. Tribal TB • scale up of AIC through activities and xi. Procurement and SCM innovations. xii. Laboratory network services
56 • Some potential interventions include: the RNTCP revised their targets for TB preventive certication of health facilities for AIC treatment. The new targets are to provide TPT to compliance; facility risk assessment; 7.5 million eligible individuals by 2022 and cough corners; personal protective continue the rapid scale-up by providing TPT to at equipment for staff and periodic least 5 million eligible individuals in expanded screening for TB signs and symptoms; target populations in 2022 and beyond (Figure 25). separate infection prevention facilities for infectious drug sensitive (DS) and DR Achievements TB patients; ongoing monitoring • Since 2017, and particularly in 2019, there dashboards or checklists for AIC has been a marked increase in coverage of practices etc. TB preventive services among child household contacts of TB patients Following the UNHLM on TB in September 2018, (Figure 26). Figure 25: Shows the new TPT coverage targets.
• Some progress has also been noted in households of notied TB patients were household contact investigation to reach visited with 378,000 child contacts child contacts of TB patients for TPT identied and 247,000 (65 percent) child provision. In 2019, close to 40 percent of contacts received TPT (Figure 27).
Figure 26: Shows the progress made in TPT coverage among child household contacts.
57 Figure 27: Shows the progress made in household contact investigation among child household contacts.
Figure 28: Illustrates the progress made in TPT coverage among PLHIV.
• Since 2017, national TB and HIV programmes have also demonstrated momentum in improving the coverage of TPT for PLHIV (Figure 28). Close to 52 percent of PLHIV on treatment have received TPT by 2019.
58 • RNTCP is also currently testing operational TB and HIV programs; feasibility of the WHO mobile application - Low coverage of TPT among PLHIV in Chhattisgarh to strengthen recording newly enrolled in care (Figure 29); and reporting of cascade of care for TB - Low coverage of household contact preventive treatment. investigations; • Some sporadic examples of good practices - Restricted eligibility criteria for TB of AIC were also observed. For example, preventive treatment; TB screening among healthcare workers - Shorter regimen of TB preventive using CB-NAAT in Chhattisgarh, treatment has yet to be implemented; vulnerability mapping, cough corners, AIC awareness campaigns and distribution of - Lack of policy to fast-track “coughers” in home AIC kits in Kerala. waiting areas in secondary and tertiary care hospitals; Challenges and Opportunities - Non-existent contact investigations for TB patients detected and notied from • While important rst steps were taken by private sector; and the program to start TPT interventions, some gaps remain: - Missing information due to gaps in cascade data (in NIKSHAY and/or - Low priority given to TPT by the national patient records).
Figure 29: Illustrates the low coverage of TPT among PLHIV newly enrolled in care.
• Similar to TPT, crucial rst steps were made - Triage and fast tracking of symptomatic in AIC, but there are persisting gaps: persons limited to HIV care sites; - Low priority given to AIC by national TB - Absence of consistent supply and use of and HIV programmes and the general personal protective equipment (e.g., health system; N95 particulate respirator masks) (only - Lack of implementation of AIC seen in MDR-TB centres); and interventions at health facilities; - Inadequacy of health care workers
59 (HCWs) screening practice and data on of TB preventive treatment and follow-up to TB among HCWs complete the course of preventive treatment. Recommendations b. Aggressively promoting engagement of 1. Secure the funding and resources to support peripheral health institute (PHI) staff, the planned rapid scale-up of expanded community structures/initiatives, etc. evaluations to benet from TB preventive c. Providing additional human resources at services by reaching 5 million per year and district- and state-level to support, cover all eligible individuals by 2022 (and supervise and monitor implementation. beyond) with TPT by RNTCP. The MoHFW and 6. Expand the scope and coverage TB preventive NHM should make available and approve the treatment services so that it is in line with the increased budget necessary to support: milestones of UNHLM (2022) and India’s expansion of contact investigation to ALL target to End TB 2025 by: household and other contacts; mapping of a. Start a nationwide catch-up campaign to target populations; roll-out of shorter achieve universal TPT coverage for all preventive treatment regimen; increased LTBI PLHIV in care and child (under ve-years of testing; the increase in human resources age) household contacts of notied TB needed to support TPT efforts; demand patients. The ultimate goal is to achieve generation for interventions; implementation this universal coverage (including those of AIC; consistent availability of IC precautions notied by the private sector) among these and personal protective equipment. two eligible groups by 2021. 2. Establish a TB prevention cell at national- and b. Consider immediate expansion of the state-level to coordinate implementation and target population for TB preventive monitoring of TB preventive services. This treatment in line with the latest WHO includes providing additional dedicated staff guidelines with the goal of achieving at the TB unit level to coordinate, supervise nation-wide TPT coverage among all and monitor expansion of TB preventive eligible contacts by 2022. treatment services and systematic i. Start implementation of TPT for implementation and monitoring of AIC household contacts ve-years of age measures. and younger in select demonstration 3. Integrate TB preventive services in all ACF districts and/or union territories to efforts at health facilities, in communities and generate country experiences by rst among vulnerable populations. and second quarter of 2020. Within a 4. Integrate TB preventive services into all efforts subset of the target population in for public-private initiatives (e.g., JEET, PPSA) demonstration sites, conduct systematic to ensure systematic contact investigation and LTBI testing and X-ray to generate local linkage to TB preventive treatment for all data on the burden of LTBI and eligible individuals. determine the need for a systematic LTBI 5. Strengthen household contact screening and testing policy for further scale-up. In evaluation by: these demonstration districts national a. Developing and providing a package of programme should consider nancial incentives for service providers outsourcing of collection of blood (public and private) to ensure access to specimen, transportation and testing public transportation and to necessary while skin-test-based technology laboratory tests, complete coverage of becomes available for programmatic household contact investigation, initiation use.
60 c. Establish mechanisms for TPT adherence implementation of administrative and support and adverse events monitoring to environmental measures such as: ensure prompt action and management of a. Leveraging ongoing initiatives (e.g., scale- the rare adverse events. up of health and wellness centres under the d. Build staff capacity for counselling to Ayushman Bharat scheme and initiatives address the specic needs of healthy adult by the NHM such as Kayakalp) and contacts and other target populations by promote inclusion of AIC as a criterion for providing training, job aids, and other awards. supportive tools. b. Consider launching a sustained national e. Expand the coverage and monitoring of TB campaign for cough hygiene (e.g., preventive services to other WHO implement mass media, awareness recommended clinical risk groups (e.g., programmes in education institutions). patients on dialysis, anti-TNF treatment). c. Developing and rolling out an updated 7. Rapidly adopt and expand implementation of implementation guide and supportive shorter rifamycin-based TPT regimens (e.g., standard operating procedures on AIC (to 3HP, 1HP, 3HR, 4R) include information on patient ow, a. Considering the rapid scale-up of engineering measures at health facilities, molecular diagnostics, the National etc.). programme should explore TPT for d. Promoting innovations (e.g., AIC helpdesks contacts of DR-TB patients based on drug to help identify and fast-track presumptive susceptibility patterns of index cases. TB patients). b. The National programme should also e. Ensuring compliance with national AIC consider procurement of technology-based guidelines at the RNTCP supported tools for adherence support to support the facilities (e.g., laboratories, MDR-TB wards, shorter regimen treatment (e.g., ICT, IDAT). others) by leveraging infection control Lack of availability of Pyridoxine (vitamin committee meetings. B6) should be promptly resolved to prevent f. Taking a leadership role in coordinating common adverse events associated with H and monitoring AIC compliance in all use, but should not be considered a health care facilities. bottleneck in starting TPT. g. Develop and disseminate information, 8. Strengthen monitoring and evaluation by education, and communication (IEC) ensuring that data is systematically captured specic for AIC and TPT (e.g., promoting on cascade of care for TPT in the NIKSHAY routine cough hygiene, fast-tracking platform and scaling up digital tools like LTBI presumptive cases). mobile application and contact register. These 11. Strengthening measures to protect HCWs by efforts should also include mechanisms to implementing: assess TPT completion and monitor TB among a. Mandatory, systematic screening HCW for HCW. TB as a part of overall health checkups at 9. Employ the help of TB survivors and recruitment, annually and as needed. champions to generate TPT demand. b. Large coverage of free access to CXR, CB- Operationalize and leverage the newly NAAT, and additional tests for TB infection released Guidance Document on Partnerships (TST, IGRA). for advocacy and implementation of TPT activities. c. A referral and follow-up process to ensure for HCWs who are screened positive for 10. S t r e n g t h e n A I C t h r o u g h e f f e c t i v e latent TB are provided at least one course of
61 shorter TPT regimen followed by ongoing 2.3 Detect surveillance for emergence of TB symptoms. 2.3.1 Case Finding, Diagnostics and 12. Continue research and fast-track adoption of Laboratory Services new products and innovations: Within this thematic area, we discussed the a. Engaging the ITRC in designing and implementation of the NSP 2017-25 strategy for 1) validating new vaccine candidates the early and complete detection of all TB patients (including the two candidates (VPM1002 including intensied case nding strategies and and MIP) that are currently in Phase III trials. addressing high risk populations, and 2) the b. Continuing to support vaccine research provision of diagnostic services with a focus on and fast-track clinical trials and necessary revised laboratory expansion plan, planning for regulatory approval procedures so that the scale-up of new diagnostics within the revised products could progress through all stages Technical and Operational Guidelines for TB of validation. Control in India(all forms) in both adults and children and public-private partnerships for c. Fast-tracking validation and roll out of LTBI laboratory testing and specimen transport. diagnostic tests (e.g., C-TB, NGS, IGRA). d. Approving rifapentine for programmatic Achievements use. • All diagnostic tests for all forms of TB are e. Addressing concerns around the high available free of direct cost in the health background rate of H resistance. The system at all levels. National programme should consider • TB patient notications have steadily using shorter rifamycin based regimen improved over the past three years – from (e.g., 4R), enhancing coverage of drug both public and private sector health sensitivity testing of index cases (including facilities. patients notied by private sector) and generating evidence around use of index • Many states are meeting or exceeding case DST-guided preventive treatment targets for patient notication in the public regimen among eligible contacts. Data sector. collected from implementation may inform • The presumptive TB case rate has been global guidance for the management of steadily increasing over the past three contacts of drug resistant TB cases. years. • In 2018, approximately 189 million Key Messages persons were screened for TB during active The JMM team recognizes that the program has case nding investigations and 47,307 TB taken signicant strides in ramping up TB patients found. prevention services, including aligning its targets • Microscopy services appear to be with UNHLM goals and rolling out of TPT to PLHIV adequate. Microscopy services have been and child household contacts. In order to reach a expanded and further decentralized from TB free India by 2025, the JMM team recommends 1 per 100,000 to 1 per ~65,000 an increase in funding and resources with specic population. External quality assessment attention to support the scale-up required of both consists of blinded rechecking and on-site TPT and AIC activities to meet these ambitious evaluations (OSEs). targets. • There has been a dramatic expansion of molecular testing from 620 sites in 2015 to 1530 sites in 2018. The Truenat MTB and
62 MTB Plus test have been evaluated and are with RR-TB additional DST should be being deployed to increase further done for at least uoroquinolones. molecular testing capacity. - In many states, 60 to 70 percent of • All diagnostic tests for pre-treatment eligible notied patients diagnosed in evaluation are available free of direct cost the public sector received a CB-NAAT, at the nodal and district DR-TB Center. but only 15 to 25 percent of eligible notied patients in the private sector Challenges and Opportunities received a CB-NAAT. The completeness of contact investigation as a tool - Patients are required to do three or four for active case nding and identifying candidates visits to get a diagnosis (smear) and for preventive therapy coverage are variable. eventually submit a sample for CB- While contact investigations for patients diagnosed NAAT. in the public sector were usually done, contact ¿ Patient-important turnaround times investigations for patients diagnosed in the private (TAT) (from diagnosis to receipt of sector were often lacking. Household contacts laboratory test results) can be greater younger than six years of age were not consistently than two weeks for a test that takes two placed on TPT (as detailed in the Prevent section hours. above). - Many newly diagnosed smear-positive • Documentation of contact investigations, patients are not monitored to ensure their laboratory evaluations, and outcomes they submit a specimen for CB-NAAT. were often incomplete. Patients are simply referred to another • Universal DST DMC for sample collection with no - The denition of universal drug follow-up to determine if they actually susceptibility testing (U-DST) used by received the test. A process is needed to RNTCP should be reviewed as well as the track patients. method for calculating the percentage • Adequacy of laboratory infrastructure to of patients receiving a DST. The current address the diagnostic demand RNTCP denition of U-DST is actually a ¿ Human resources – lack of qualied measure for universal rapid molecular staff, training, retention, salaries, testing for detection of TB among all competencies.
notied patients (not bacteriologically ¿ The FIND support for many laboratory conrmed patients) which makes India’s technicians (LTs) in intermediate success less impressive. That is, a CB- reference laboratories (IRLs) and DST NAAT result of Mycobacterium laboratories ends on March 31, 2020; tuberculosis (MTB) not detected is not there is no clear transition to state logically different from a culture result of support of these lab positions. In the no growth – neither is a drug- Ajmer IRL for example, FIND supports susceptibility test and those patients 10 positions. should not be included in the calculation ¿ Vacancies in laboratory positions are for U-DST. common. For example, only seven of ¿ Note that the WHO denition of nine sanctioned LT positions in the universal DST is that all Ajmer IRL are lled. bacteriologically conrmed patients ¿ Senior TB Laboratory Supervisors (STLS) should undergo DST for at least are responsible for supervising up to 20 rifampicin ®. Among those detected microscopy centers and several do not
63 have vehicles and reimbursement of operations, constantly testing and adopting travel costs is often quite delayed. newer transformative ways of facilitating
¿ Salary structure is not adequate to diagnosis and maintaining TAT is a address the required competencies of challenge for the program. Effective the sanctioned positions and attract implementation of a new diagnostic suitable qualied personnel. Salaries algorithm across public and private sectors for TB laboratory workers are not will require augmentation of laboratory competitive in the marketplace. capacity. • Budget – although funds are allocated, • Precise role of PHI microscopy centres funds are not available to purchase (MCs) is unclear – some PHI MCs have supplies and reagents. There are issues insufcient number of samples to maintain with disbursement and underutilization of prociency. The number of PHI MCs to approved funds. supervise also places a large burden on - Procurement of laboratory STLSs. consumables and reagents is not taking • Rapid molecular diagnostic services: NAAT, place regularly and in a timely manner. FL-LPA/ SL-LPA, Gene Sequencing (NGS/Pyro sequencer) ¿ In some sites visited, the State had been unable to purchase reagents for • Inadequate molecular testing capacity: ~4 years which has led to the use of CB-NAAT instruments are overburdened in expired reagents. It is noteworthy that some sites, but some sites do less than 150 MGIT, CB-NAAT and LPA kits are tests a month. provided centrally by other sources • Not all CB-NAAT sites follow the national (FIND, GoI) and procurement and algorithm with respect to the priority of distribution has not been an issue. testing – 1) U-DST 2) key populations (e.g., - Maintenance and calibration of CB- PLHIV, children), 3) smear-negative, X-ray NAAT, MGIT, and HAIN instruments and suggestive of TB, 4) other presumptive TB. BSCs were being conducted and Offering CB-NAAT indiscriminately (i.e., documented through a central annual without a rigorous risk assessment) to all maintenance contract (AMC). Other persons suspected of having TB when they than instruments on the central AMC present to the CB-NAAT site is thought to be (e.g., UPS), funding for maintenance contributing to overutilization of CB-NAAT and calibration was inadequate in some and interfering with priority testing. states. Additionally, AMCs were lacking • In some states, chest X-ray is underutilized. in some states. In other states, X-ray services are not - Inadequate laboratory capacity available for hard-to-reach populations. contributes to missed opportunities for • A high proportion of clinically diagnosed early diagnosis and places a burden on patients are in the private sector – up to 80 an already overburdened nodal TB lab, percent of notied patients. This has on patients, and on community workers implications for DST as well as assessing needing to reach diagnostic services the quality, accuracy and completeness of (CB-NAAT, microscopy, underutilization TB diagnosis and patient notication. of chest X-rays). In general, TB • Sample transport mechanism diagnostic capacity and easy access • In several states, less than 40 percent of needs strengthening. specimens were received within the target • Ensuring sustainability of laboratory time of 72 hours of collection.
64 • This contributes to a high rate of quantitative errors). contamination of cultures (e.g., more than • Key performance indicators (KPIs) from IRL 20 percent for MGIT cultures) which in turn also have inconsistencies, more than results in delays in receipt of test results 10,000-line probe assays (LPAs) conducted because of the need to repeat culture and with no invalid results of errors. subsequently delays in initiation of • OSEs are being conducted but monitoring appropriate therapy. of the implementation and effectiveness of • Specimen transport occurs only once or the recommended corrective actions is not twice a week in some sites. This contributes being done routinely. to the overly long patient-important TAT • STLSs in some states have not been (from diagnosis to receipt of laboratory test provided with vehicles per national result) (e.g. more than two weeks to get a guidelines; this greatly impacts ability to result for a test that takes two hours). monitor laboratories. • Poor specimen transport creates travel burden and expenses for patients. Recommendations • In some areas, patients are referred to a Priority: testing facility rather than referring 1. Ensure that laboratory support for contact specimens. Some patients are required to investigations is readily accessible, contacts travel 50 to 60 kilometers. are comprehensively and promptly identied • Lack of MOU at state level for specimen and tested/evaluated, and quality results are transport. consistently documented to assess the yield of • Biosafety additional TB cases identied, as well as • Direction airow was inadequate or non- contacts with latent TB infection in need of TPT. existent in several of the visited facilities, 2. Urgently seek nancing opportunities to ll key which resulted in inadequate protection for stafng gaps and update salary and stafng workers, the community and the structure. environment. 3. Take advantage of the considerable testing • Biomedical Waste Management capacity available in the private sector and Guidelines (2018) were not implemented engage private sector laboratories for end-to- in all laboratories. end operations (turnkey model) including • AIC procedures were inadequate in the specimen collection, transport, reex testing, health care facilities visited, especially in- pre-treatment evaluation and providing patient waiting areas. reports within stipulated TAT for patient • Laboratory Information Management management. System (LIMS) and integration with 4. Focus ACF and intensied case nding (ICF) NIKSHAY efforts on vulnerable and high-yield • LIMS is just being implemented and populations, institutions and individuals, and seamless integration into NIKSHAY is not use sensitive screening and detection tools. yet realized. 5. Design and implement an efcient specimen • External Quality Assessment referral and results reporting system that is responsive to local epidemiology and • Blinded rechecking is being conducted. geography and minimizes patient-important However, results are concerning in some TAT. states in that very few laboratories were found to have any errors (including 6. Accelerate implementation of U-DST by
65 expanding rapid molecular testing capability reactivated TB) through efcient utilization and localization of iv. Using sensitive tests (digital chest X-ray, existing and new NAAT instruments and CB-NAAT) to detect patients during engaging private sector laboratories for the ACF/ICF screenings – do not rely on provision of molecular testing. smear only. v. Providing guidelines and training to Specically Actionable: ensure that screening and follow-up are completed correctly. Monitor the 7. Contact Investigation is an excellent quality of screening. opportunity to detect additional TB patients. vi. Evaluating cost efciency and cost a. Contact tracing must be done promptly benet of ACF/ICF and early case and systematically. detection. b. Programs must monitor and supervise 1. Note the benets of ACF are more quality and completeness of contact than case detection (e.g., raise tracing. community awareness). c. Hold the program accountable for vii. Including screening for TB in multi- completeness and quality of contact disease screening efforts in the tracing, perhaps by including an in-state community and vulnerable populations. scoring system. 9. Efcient specimen transport can improve TB d. Ensure that contact investigation of detection. pediatric TB patients to identify the source case is done for all pediatric TB cases. a. Be patient centric – refer specimens not patients. e. Repeat contact tracing at the end of treatment and during follow-up to detect b. Monitor and document KPIs for specimen newly developed cases and document referral and results reporting, especially treatment outcome. TAT. Initiate corrective actions to minimize TATs for referral for NAAT, LPA, culture, and f. Ensure availability of testing (e.g., IGRA) DST. and follow-up (TPT) for contacts. c. Perform a network optimization study of the 8. The yield of ACF and ICF is low and the specimen referral and results reporting screening is resource intensive. system. a. Focus ACF and ICF efforts on vulnerable i. Use network planning, simulation or and high yield populations, institutions and optimization tools for design and individuals by: planning with an emphasis on access i. Identifying and mapping vulnerable to services and patient ow through populations, institutions and the diagnostics cascade. individuals ii. The optimal specimen referral pathway ii. Ensuring that vulnerable individuals in may vary by geography and local high-yield settings be screened (e.g., epidemiology and infrastructure. health care facilities, shelters, old age d. Explore the use of the PPSA model to homes, refugee camps, correctional facilitate specimen collection and transport facilities and other high-risk locations, for NAAT and other testing (e.g., LPA, such as specic workplaces) culture, DST) iii. Including follow up of treated patients e. Streamline the specimen collection process as a high yield population to be actively by: screened (i.e. identify relapse and
66 i. Minimizing the number of visits needed to i. Program can learn from the experience get a diagnosis and NAAT of the National AIDS Control ii. C o n s i d e r i n g 1 ) c o l l e c t i n g Organization (NACO) who has specimens for smear microscopy; successfully contracted a private 2) storing all specimens while laboratory network that is fully smear testing is done, and 3) for equipped to do high volume testing of any newly diagnosed smear- viral loads among HIV infected patients positive patient, sending the stored across the country. specimen to the CB-NAAT site ii. Outsourcing may be particularly useful iii. Conducting training to ensure for specialized tests such as IGRAs. capacity and competency for iii. Build capacity for certication and collection of quality sputum monitoring and ensuring the quality of specimens and specimens from testing in private sector laboratories. children and presumptive Include IRLs in engaging laboratories extrapulmonary tuberculosis (EPTB) and monitoring of quality. Consider for intended use are available. institutionalizing the quality assurance iv. Ensure the availability of adequate mechanism of laboratory services for numbers of specimen collection the private sector, irrespective of free containers suitable for the intended service provision. The EQA system for use (e.g., Falcon tube for CBNAAT ELISA test in the private sector specimens). conducted by the HIV laboratory 10. Laboratory Capacity must be increased to network may be a model ad resource. meet the demands of the new TB diagnostic c. Ensure timely reporting of test results to algorithm and emphasis on rapid testing. patients and providers. a. Urgently seek nancing opportunities to ll i. Deploy diagnostics connectivity to improve key stafng gaps and update salary and reporting and monitoring of TAT. stafng structure. d. Emphasize quality, reliability and safety in i. Current stafng and salary structure the laboratory as well as the adequacy of (under NHM) are inadequate and do facilities, infrastructure and utilities. not match the skills and competencies i. Conduct and document annual training needed to address the laboratory or refresher training in biosafety for all supported need for the ambitious laboratory staff. plans of the NSP and to attract ii. Ensure that national biosafety and waste qualied personnel. management policies and procedures ii. Ensure existing experienced and are implemented in all laboratories. trained laboratory staff at IRLs and iii. Ensure that basic occupational health National Reference Laboratories services and annual TB screening of (NRLs) are absorbed with state HCWs are available in all facilities. programs as guided by GoI. e. Ensure the availability of adequate b. Engage private sector laboratories for end- numbers of well-trained competent to-end operations (turnkey model) laboratory staff in existing laboratories and including specimen collection, transport, planned new laboratories. reex testing, pretreatment evaluation and i. Take advantage of e-tools to ensure the providing reports within stipulated TAT for uniformity of training. All training must patient management. be accompanied by competency testing
67 and certication. CXR with CB-NAAT testing. f. Forecast diagnostics and laboratory f. Expand use of mobile digital CXR vans to requirements in-line with the new improve access to X-ray services in hard-to- algorithm and ensure a regular supply of reach areas. reagents and consumables. Improve 12. Accelerate U-DST for all notied patients in efciency and capacity for procurement both the public and private within state-level teams. a. Improve access to and capacity for NAAT g. Conduct a diagnostic network optimization by: exercise for existing instruments and testing i. Expanding NAAT testing capacities - capacity (NAAT, LPA, culture) to assess the add instruments and optimize NAAT need for additional laboratory capacity, instrument placement and utilization and optimize access to diagnostic services. ii. Creating mechanisms for outsourcing h. Expand capacity of conducting extra- molecular tests to private sector pulmonary tests like imaging, laboratories in areas where RNTCP histopathology, cytology at least one in capacity is over-utilized or not available each district - either through public or iii. Ensuring that NAAT sites follow the private sector. priorities in the national testing i. Evaluate the utility of noninvasive algorithm. Give priority to testing for U- procedures and alternative biological DST and for key populations specimens (e.g., stool) for diagnosis of TB iv. Conducting rst line-LPA testing in in children). accord with national diagnostic testing 11. CXR is an important entry point into the TB algorithm. diagnostic algorithm. Especially with respect b. Sensitize private sector providers to the to triaging smear-negative presumptive TB importance of submitting specimens for patients and children for further testing (e.g., DST. CB-NAAT) as well as screening during ACF/ICF. c. Consider providing incentives for submitting specimens for U-DST. a. Standardize CXR utilization through clear standard operating procedures for TB d. DST Algorithm and capacity must also screening, diagnosis and treatment address DST for the new drugs (e.g., BDQ). monitoring. e. IT enabled patient support systems could b. Dene the role of and access to timely tele- also be a choice for ensuring complete radiology. Expand X-Ray reading capacity coverage of U-DST. through tele-radiology, training of medical Key Messages: ofcers and use of articial intelligence 1. Minimize patient-important TATs (time from enabled tools. diagnosis to taking action on a test result) to c. Clearly dene the role of CXR as a triage avoid delays in diagnosis and initiation of tool for NAAT in the national testing appropriate therapy as well as loss to follow. algorithm and implement. 2. Use a systems approach to develop a robust, d. Enforce and monitor adherence to CXR patient-centric diagnostic system that algorithms. emphasizes access to quality-assured rapid e. Develop systems to track CXR conducted, molecular tests and ensures the timely ow of CXR abnormal, and referral for further specimens and information. testing and to track linkage of abnormal 3. Prioritize conducting, documenting and
68 monitoring systematic contact tracing. Hold - Expand contact investigations and use programs accountable for completeness and of TPT. quality of contact tracing, perhaps, by - Develop epidemiological strategies to including contact tracing in-state scoring identify transmission of infection in system. critical populations and geographical 4. Focus ACF/ICF on vulnerable populations and zones. individuals and use sensitive tests to improve - As tools become available, consider yield. Make ACF more efcient and less methods and strategies to identify and resource consuming. treat subclinical, or incipient, TB. • Implement or expand a surveillance system Additionally, the team would like to highlight the for DR-TB in order to better understand and new ideas or strategies presented in this section that address trends in the epidemiology of DR- are beyond the current NSP: TB in the various regions of the country. • To increase TB case detection, implement a phased replacement of smear microscopy with NAAT as the initial diagnostic test for 2.4 Treat all persons with presumptive TB. 2.4.1 Treatment Services for Drug - This is mentioned in the NSP and would Sensitive Tuberculosis require 8,000 NAAT instruments. In this section the team examined the current - Cost estimate: about 50 million USD to implementation and gaps of treatment of drug test 20,000,000 presumptive TB sensitive TB (DS-TB) strategies as presented in the patients - 15 million USD for NSP. The subsections below specically focus on six instruments and 32 million USD of the nine proposed activities in Chapter 7 of the annually for cartridges. NSP: Treatment Services. These focus areas are: - Acid-Fast Bacillus (AFB) smear adherence and monitoring, care cascade microscopy will still have an important monitoring, private providers, patient empowerment, role in treatment monitoring, clinical support, and pharmacovigilance. screening for NTM, and as triage test in some settings. Achievements - The role of chest X-ray as a triage tool for NAAT should be clearly dened and • The RNTCP programme has adopted implemented in the national testing global recommendations on treatment of algorithm. DS-TB. In 2018, the country eliminated the ‘Category II’ regimen for Previously • Rapid and reliable laboratory testing is a Treated TB patients. With this move, the patient right programme is now providing an all-oral - Increase community awareness of the regimen for all DS-TB patients, and has TB diagnostic pathway and been able to address the issue of adverse opportunities to seek care – promote events arising due to injectable use. care seeking behaviors and reduce • The Programme has also worked towards patient drop out. empowering TB survivors by conducting - Create demand from private sector mentorship training for them and clinicians for access to rapid testing. developing their capacity as “TB • Emphasize prevention of infectious TB – Champions”. These Champions have stop TB before transmission occurs been playing an increasing role in
69 treatment support for TB patients. They are ¿ It has been noted that most supervisory strong, credible, and vocal advocates who staff, including the most crucial not only support but also own the cause of position of STS, are nding it difcult ending TB. States and Districts have also to devote time to monitoring and enacted TB forums in which TB patients, or supervision of programme activities their families are represented, and due to being burdened with tasks administrators directly interact for related to DBT. feedback about diagnostic and therapeutic • While long-term follow-up of patients at services. 6-, 12-, 18- and 24-months post • Furthermore, engagement with the private successful completion of treatment is sector has increased which has enabled already a part of the National Policy, it is better adoption of RNTCP policies and not being implemented. better provision of public health action by • A need to also conduct long-term contact the programme for patients seeking care in investigations was observed as it is known the private sector. This has also led to a that TB occurs in both adult and children signicant increase in the notication from family members and contacts of infective the private sector. TB patients, with the maximum probability of disease in the rst two years following Challenges and Opportunities exposure. While great strides have been made, there are • Insufcient prioritization and persisting programmatic challenges. Based on the implementation of adherence technology. eld visits and inputs from various experts, the - Lack of clarity among eld staff on DOT group has identied the following challenges in the procedures, including frequency of implementation of NSP 2017-25 focus areas. DOT. After the introduction of a daily regimen for DS-TB, daily DOT is Adherence and Monitoring: required but this is not happening at the • Lack of sufcient monitoring and eld-level. supervision by programme managers and - In addition, multiple options for supervisory staff continues to be an adherence are now available and the ongoing challenge in implementation of choice is expected to be made by the policies. peripheral staff in concurrence with the - Certain aspects of the treatment of DS- patient. TB patients such as the need for ensuring - Insufcient or slow uptake of IDAT in the that patients actually consume their states the JMM team visited. ICT based medicines, is highly dependent on the adherence technologies have also been supervision of treatment supporters in introduced, but their adoption is the community and institutions. dependent on the states. Supervisory staff must ensure that the support being offered by treatment Diagnosis and Care Cascade supporters to the patients is sufcient Monitoring: and as per patient needs. • Quality and frequency of staff training is - There is a dearth in monitoring the highly variable. availability of medicines, timely and - The team observed that many practices complete lling up of records, NIKSHAY did not comply with RNTCP prescribed entry. guidelines (e.g., non-adherence to the
70 diagnostic algorithm, difculty in Pharmacovigilance: identication and management of • Limited capacity for proper identication, adverse events). management and reporting of adverse - Additionally, it was noted that the quality events (Aes), especially for FDCs. of training was not being measured. Many quality issues such as delay in Recommendations obtaining laboratory results and consequent delay in initiation of Adherence and Monitoring: treatment were also noticed by the 1. Outsource or provide TA to address the burden group. These system issues in the care of DBT at the state- and district-level. In order cascade of a TB patient (e.g. detection, to enable better supervision and monitoring of treatment, prevention of TB care) need activities, technical and supervisory staff of to be addressed through regular good- RNTCP to be freed from DBT related tasks. quality training. 2. Implementation of a monthly review of STS, STLS, and or medical ofcer TB control (MOTC) Private Providers: by DTOs using a checklist should also be made • No system is in place to track treatment mandatory. adherence, compliance and outcomes of 3. Generate a geo-map to illustrate location and patients in the private sector. In India, most availability of supervisory staff. Consider patients in both rural and urban areas tend providing tools (e.g., tablets) for this exercise to seek care from a private provider, which from the national-level. signies a need for better strategies for 4. Ensure that long-term follow-up (for up to two private sector provider engagement in years) post-treatment is being observed. ensuring universal access to quality TB care Additionally, both children and adult contacts for all. should also be followed up for two years to enable early detection and treatment of TB Patient Empowerment: disease. • The programme has supported the a. Using the Kerala model for contact establishment of a TB Champions network investigations as an example, consider but continued scale-up and induction of employing the use of a patient-based effective TB forums at all levels is not yet register for recording the prescribed long- realized. term follow-up of patients and contact for two years. Clinical Support: 5. Prioritize the implementation of adherence • Lack of implementation of the diagnostic technologies by: algorithms across all facilities. The JMM a. Ensuring the availability of DAT at the state- team observed this at many of the facilities level. visited. b. Tailoring adherence technologies to • Absence of proper progression of patients, individual patient needs by using a whose weight increased by more than ve combination of DAT and traditional kilograms, through weight bands adherence support mechanisms as • An observed need for decision making needed. support systems for healthcare providers at i. Consider employing a checklist to all levels was noted. enable staff at the treatment centres to work with the patients to nd the right
71 combination. The JMM team suggested taking into consideration the patient’s that mechanisms should be prioritized medical and practical needs, personal into three categories/mix of choices, and agency. interventions: d. Building capacity of all treatment 1. First priority: Digital adherence supporters, especially community and technology (99DOTS for DSTB/ family-based treatment supporters, MERM for DRTB & Pediatric TB) in through the PHI. This could include addition to family members as informational brochures in local treatment supporters (followed by language(s) on basic TB knowledge, once a week supervisory visit to transmission, treatment, and role of DOT patient’s home by supervisory staff to highlight the importance of adherence, of the PHI). and integrated into the general health 2. Second Priority: Community based system based on PHI. (involving ASHA or other community member) institutional Care Cascade Monitoring: treatment supporter depending on 6. Implementing quality training both at time of the distance a patient has to travel. onboarding and regular intervals thereafter at This option may be applicable for all levels. patients who are not eligible or not a. Consider structuring onboard training as willing to use DAT. modules to cover the various key topics. 3. Third Priority: In cases like sick and b. Realize the potential and optimize bed-ridden patients or children, a utilization of e-platforms (e.g., ECHO, family member could be assigned Swasthya e-Gurukul) for training. with the responsibility to be the 7. Employ the quality improvement (QI) model to treatment supporter for the patient. help staff identify problems, build a team, In these cases, too, supervisory visits conduct root cause analyses, and begin the by PHI staff would be required to plan, do, study, act (PDSA) cycle on a biannual build the capacity of the family to basis (Figure 30). offer DOT. a. Performance should be measured on a run c. Ensuring that a joint informed decision chart with course correction every three to (between the patient and provider) is made
Figure 30: A visual representation of the PDSA cycle.
72 six months if no signicant progress is reference. recorded. 16. Develop a ‘clinical decision support’ (CDS) Private Providers: tool and integrate into the NIKSHAY system. This tool can help address the lack of standard 8. Explore the feasibility and consecutively diagnostic algorithms and assist staff in support the establishment of System for TB prescribing the correct regimen. An Elimination in Private Sector (STEPS) Centres in additional indicator of clinical decision all private healthcare facilities (i.e., Kerala), support can also be considered for data entry along with a formal evaluation to inform its into NIKSHAY. expansion to other states. 9. Optimize the role of JEET staff for PPE including Pharmacovigilance: empowering staff to suggest potential PPSA mechanisms for PIPs. 17. Build and further strengthen the capacity of eld workers and treatment supporters to 10. Better utilization of JEET staff for engagement identify symptoms of possible Aes. with private practitioners and proposing other PPSA mechanisms through the PIP. 18. Implement regular trainings, sharing of case studies and e-training sessions (e.g., through 11. PPSA mechanisms will need to support private ECHO/Swasthya e-Gurukul), to enable providers mapping, referral for medical ofcers to better identify and manage diagnostics/treatment/public health action to AEs due to FDCs. the public sector, training of private providers on RNTCP protocols, and NIKSHAY reporting, 19. Establish clear pathways of referral for AEs for and ready access to free FDC for privately the treatment supporter. A model referral treated TB patients. pathway may be recommended by the programme which should then be adapted to Empower patients: local settings by the district/sub-district-level, 12. Support the scale up of the network of TB keeping in mind the practical feasibility. Champions using NGOs and other partners. 20. Develop and disseminate clear information to a. Important to ensure the neutrality and the states, districts and PHIs on the availability independence of the network of of loose drugs for rst-line-treatment that may Champions. be used in the event of AEs due to FDCs. b. Consider strengthening the role of TB Champions as peer-supporters for TB Key Messages patients cared for in private and other 1. Ensure treatment adherence and strengthen its sectors. supervision and monitoring using new digital 13. Leverage the reach of TB Champions to adherence technologies. interact with high-risk populations and 2. Strengthen and sustain high-quality training patients that have a history of adherence for staff at all levels. issues. 3. Effective PPE in the management of DS-TB 14. Harness the experience of TB Champions to management along the care cascade from inform policy makers about how to better mold case nding to treatment outcome. service delivery for specic patient groups. 2.4.2 Programmatic Management of Clinical Support: Drug-resistant Tuberculosis 15. Beyond training(s), build capacity of staff with India is one of the twenty countries listed by WHO resources and materials (e.g., ready with the highest estimated numbers of incident reckoners, pamphlets, job-aids) for easy MDR-TB cases. The First National Drug Resistance
73 Survey (NDRS) (2014 – 2016) has been completed. percent, and among all patients 6.2 percent (Table Any drug resistance among new patients was found 9). This translates into an estimated 130,000 to be 22.5 percent, among previously treated (77,000-198,000) individuals suffering with MDR- patients 36.8 percent, and among all patients 28 TB/RR-TB emerging each year in the country. percent. MDR-TB among new patients was 2.8 percent, among previously treated patients 11.6
Table 9: Results of 1st National DRS survey, 2014-2016
New TB patients Previously treated DST results (95% CI) patients (95% CI) DST results 3065 1893 4958 Susceptible 2374 (77.46%) 1196 (63.18%) 3570 (72.01%) (75.93 – 78.92%) (60.96 – 65.36%) (70.73 – 73.25%) Any drug resistance 691 (22.54%) 697 (36.82%) 1388 (28.02%) (21.10 – 24.10%) (34.64 – 39.04%) (26.77 – 29.29%)
Any drug resistance 691 (22.54%) 697 (36.82%) 1388 (28.02%) (21.10 – 24.10%) (34.64 – 39.04%) (26.77 – 29.29%)
MDR 87 (2.84%) 220 (11.62%) 307 (6.19%) (2.28 – 3.49%) (10.21 – 13.15%) (5.54 – 6.90%)
MDR + any second line 6 (6.90%) 5 (2.27%) 11 (3.58%) injectable agent (SLI) (2.57 – 14.41%) (0.74 – 5.22%) (1.80 – 6.32%)
M D R + a n y 21 (24.14%) 46 (20.91%) 67 (21.82%) uoroquinolone (FQ) (2.57 – 14.41%) (15.73 – 28.89%) (17.33 – 26.87%)
Extensively drug 2 (2.30%) 2 (0.91%) 4 (1.30%) resistant TB (XDR-TB) (0.28 – 8.06%) (0.11 – 3.25%) (0.36 – 3.30%)
Source: https://www.tbcindia.gov.in/showle.php?lid=3315 Achievements • Laboratory capacity has continued to be The RNTCP initiated services for DR-TB patients in scaled up, with 1,530 CB-NATT (i.e., 1,180 2007, and has in recent years made great strides GeneXpert, 350 TrueNAAT) units available since that start. Many new initiatives have been across the country (vis a vis NSP 2019 introduced to improve DR-TB care. target of 1835), 64 laboratories conduct LPA testing (vis a vis NSP 2019 target of 54), • The updated 2019 RNTCP PMDT and second-line drug susceptibility testing guidelines are aligned with current global (SL-DST) is available in all States. The recommendations. “Universal” DST (i.e., revised integrated DR-TB diagnostic testing of all TB patients for R resistance) algorithm recommends testing of all was initiated in September 2017 and notied TB patients for R and H resistance, scaled-up to the entire country from and all RR-TB patients for uoroquinolone January 2018. (FQ) and second line injectable (SLI) (Figure 31).
74 Figure 31: Revised integrated DR-TB diagnostic algorithm.
• There is country-wide access to treatment between 6 to 17 years - a cumulative regimens with new and repurposed drugs total of 321 patients have been enrolled (FQ, linezolid [LZD], clofazimine [CFZ]). up to September 2019. Namely: • The 2019 guidelines recommend that the - Bedaquiline (BDQ) containing regimen number of standard regimens for the - a cumulative total of 7,965 patients various DR-TB patients be reduced from the have been enrolled up to September current 11 to 3 (6-9 months regimen for H 2019; mono-/poly-resistant patients; 9 to 11 - Shorter treatment regimen (STR) for DR- months STR regimen; a 18 to 20 months TB patients - a cumulative total of fully oral longer regimen containing new 46,129 patients have been enrolled up drugs for those RR-/MDR-TB patients to September 2019; ineligible for the STR – currently available - Regimen for H-resistant cases a in 7 states [Delhi, Gujarat, Kerala, cumulative total of 18,904 patients Karnataka, Puducherry, Tamil Nadu and have been enrolled up to September West Bengal]) (Table 10). Once all the 2019; and necessary capacity building has been completed, the regimen will be rolled out - Delamanid (DLM) containing regimen is to the remaining states. The choice and available in 7 states (Chandigarh, design of treatment regimens for children Kerala, Karnataka, Lakshadweep, is as for adults. Orissa, Punjab and Rajasthan) for adults and in all states for children aged
75 Table 10: Standard regimen for initiating treatment of RR-/MDR-TB or H mono- or poly DR-TB
Regimen class Intensive phase Continuation phase
H mono/poly DR TB (R resistance not detected and H resistance)
All oral H mono-poly DR-TB Regimen 6 Lfx R E Z
RR-/MDR-TB
Shorter RR-/MDR-TB regimen 4-6 Mfxhd Km/Am Eto 5 Mfxhd Cfz Z E Cfz Z Hh E
All oral longer RR-/MDR-TB regimen 18-20 Bdq(6) Lfx Lzd Cfz Cs
Source: 2019 RNTCP PMDT Guidelines
• In 2019, an estimated 67,241 RR-/MDR-TB patients will be notied (85 percent of NSP target). However, this equates to just 52 percent of the estimated overall MDR-/RR-TB burden as per WHO. 89 percent (59,945) of the notied patients were placed on treatment (Figure 32).
Figure 32: An illustration of the MDR-/RR-TB patients notied and initiated on treatment as compared to the targets.
• In 2019, 15,721 Hr-TB patients were notied (just 16 percent of NSP 2019 target, Figure 33)61
61Note that the presented totals for 2019 are annualized estimates based on data available up to September 2019.
76 Figure 33: This graph illustrates the number of Hr-TB patients were notied and initiated on treatment as compared to the NSP targets.
• Treatment is largely ambulatory, with the of U-DST to patients notied from the private management and care of DR-TB having been sector, free diagnostics and drugs, availability decentralized to the district level of patient support mechanisms, and access to predominantly. To date, there are 151 nodal new drugs in coordination with the DR-TB centres and 526 district DR-TB centres. N/DDRTBCs. The nodal DR-TB centres are primarily • States and districts have been provided with responsible for the initiation of DR-TB who are the local purchase of SLDs in the event of any ineligible for the STR, and managing patients drug supply chain issue in order to ensure who either have complicated disease and/or uninterrupted availability of SLDs for the DR-TB serious adverse events during their treatment. patients. Active drug safety monitoring and • Support structures for patients have been put in management (aDSM) mechanisms have been place. There is counseling provided to the introduced in partnership with the patient and family via professional counseling Pharmacovigilance Programme of India services through nodal DR-TB centres, for (PVPI). Initially a cohort event mechanism was cough etiquette and other aspects of AIC, implemented at the BDQ Conditional Access information on the disease and treatment, and Programme (BCAP) sites for the rst 600 linkages to social protection schemes, along patients treated with BDQ containing with travel support for travel for sample regimens. Subsequently, the intermediate collection, pre-treatment evaluation and package for active TB drug safety monitoring adverse event management. Financial and management (dened by WHO as support via NYP of Rs. 500 per month is reporting of all serious adverse events and AEs provided until completion of treatment. of special interest) was endorsed by RNTCP for • The private sector has been engaged in roll-out to all sites treating DR-TB patients. various aspects of the diagnosis and treatment • Despite the many achievements of RNTCP in of DR-TB patients, ranging from the provision regard to the provision of PMDT, the reported
77 treatment outcomes overall to date remain resistant patterns, reported 71 percent poor. The reported treatment success rates in success. Patients enrolled in later years on the the 2016 patient cohort were 48 percent for STR and on the Hr-TB regimens had better- MDR-/RR-TB patients enrolled on the reported success rates, although 58 to 60 conventional MDR-TB regimen, and 31 percent for the STR is lower than expected and percent for the treated XDR-TB patients (Figure the program intends to analyze reasons for 34). However, patients treated under the the same. BDQ-CAP initiative, who had more extensive
Figure 34: This graph shows the trend in the treatment success rate for DR-TB from 2012 to 2018.
• Of the PMDT related recommendations proposed research topics were “partially from the JMM 2015, two have been achieved” overall (see section on Research completely achieved, 12 have been and Innovation). partially achieved and/or are ongoing62 Those recommendations related to
62Completely achieved (2): Consider revisiting treatment duration as per the WHO 2011 PMDT guidelines; The RNTCP should continue to procure SLDs at the Central level for the entire country. Partially achieved (12): The JMM recommends that the RNTCP carry out a study to understand the drivers of the DR-TB epidemic; The RNTCP should strengthen the e-health management information system between diagnostic facilities, programmatic units and treatment centres; The RNTCP should address the factors associated with unfavourable treatment outcomes and should - i. continue building capacity to offer DST at diagnosis in all TB patients, with prompt initiation of appropriate treatment, ii. promote and monitor STCI in the private sector, iii. modify treatment according to DST results, iv. ensure timely payments of enablers and incentives as per existing policy and offer nutritional interventions to patients and their families where appropriate, v. strengthen adherence monitoring and support via counselling, pharmacovigilance and community engagement, vi. explore and implement alternative patient adherence support systems, vii. implement scale up linked to local capacity for earlier detection and move towards universal DST as per the NSP 2012-2017; viii. introduce new drugs as per WHO recommendations (BDQ and DLM); The MoHFW should strengthen the mechanisms for engagement of all uninvolved medical colleges in RNTCP’s PMDT activities, and enable private providers to have access to RNTCP’s network of rapid diagnostic laboratories; The MoHFW should support better linkages for MDR-TB patients and families to social support schemes such as the RSBY, etc.
78 Challenges TB patients during the Q1 to Q3 2019 had • Whilst the recent national DRS survey a SL LPA test conducted. Challenges were quantied the level of DR-TB burden in the observed in sample collection, country, the drivers of the DR-TB epidemic transportation, and TAT of results versus remain little understood. The targets laid implementation of the current (2017) out in the ambitious NSP are challenging in diagnostic algorithm. TATs were reported themselves. However, they need to be in weeks or even months for rapid even more ambitious if the actual DR-TB molecular based tests (with test times of 90 epidemic in India is to be tackled. minutes [CB-NAAT] and 36 hours [LPA]). The implementation of the 2019 • Many of the challenges faced by RNTCP in diagnostic algorithm will require a implementing PMDT are cross-cutting, signicant increase in laboratory capacity, being impacted by many different areas of especially of the rapid molecular tests (CB- the health systems and partnerships. NAAT and LPA), and DST for the new and Human resources and their development repurposed drugs. It will also need to be remain a major cross-cutting issue for both revisited based on the recommendations the public and private sectors. This relates of the NTEG - Diagnostics group, the new not just to adequate numbers of staff, but guidelines of CDC/ATS/IDSA and the also their job responsibilities, and capacity. upcoming WHO recommendations / With the adoption of the updated 2019 guidelines. PMDT guidelines, there will be a huge challenge related to their dissemination, • Delays in pre-treatment evaluation and training and implementation. initiation of treatment were observed during the eld visits. There was variable • The terminology and implementation of availability of the SLDs across the states, “Universal DST” as practiced today is with uniform unavailability of pediatric somewhat misleading, being conducted friendly SLD formulations. on notied cases and a select group of presumptive cases rather than on all the • The percentage of patients enrolled on presumptives (see Figure 31). Bdq-containing treatment regimens out of those who were eligible, was low and the • Also, although at a national level, it was reason for this was overall unclear reported that over 50 percent of notied TB although resistance by clinicians to initiate cases had been tested for resistance to at patients on the new drugs was observed by least R, this varied across locations and some eld teams. sectors. For example, in Gorakhpur district, the overall gure was given as 45 • Quality assurance (QA) systems under the percent (Q1 to Q3 2019). However, the local drug procurement mechanisms were levels amongst those patients notied from unclear, and the agent tasked with such the public and private sector were activities is not appointed. Drug stock signicantly different with that of private management and storage at state and sector patients much lower (64 versus 17 district level were observed to be sub- percent) – this nding was seen more optimal. widely than just in the Gorakhpur district. • It was observed in certain sites that the • Although improving, only 70 percent management and care of the DR-TB (29,217 / 41,611) of the notied RR-/MDR- patients had not been completely
79 decentralized. The respective teams were 2. A better understanding of the burden of DR-TB in however unable to explore this issue further the private sector is also required and RNTCP to gain a better understanding of the needs to explore how this can be assessed. reasons for this. But at other sites, issues 3. Institutional strengthening of DR-TB spaces: were observed with infrastructure at the national-, state- and district-level with capacity district hospitals, training and linkages for building, ensured stafng, mentoring, pre-treatment evaluation. monitoring and reporting linkages. • There were consistent concerns from the Specialized tertiary level institutions to be observations of the JMM from the eld introduced at the top of the proposed tiered visits, related to supervision activities and network of DR-TB care institutions. the monitoring of the quality of patient 4. Use of modern technologies and methods care. The supervisory staff were observed (e.g., use of e-platforms, blended learning, to be heavily engaged in more etc.) for capacity building (both via pre- and administrative processes (e.g., DBT in-service training), mentoring and monitoring distribution) to the detriment of eld of said activities. supervisory activities. 5. Align and streamline health information • The quality of patient care, taking in systems between diagnostic facilities, various aspects such as counselling, programmatic units and treatment centres to laboratory investigations, treatment ensure timely transmission of all relevant adherence, adverse events monitoring and information/data, with complete linkage and management, follow-up examinations integration to NIKSHAY and NIKSHAY and patient support, was observed to be of Aushadhi. concern. As yet, the integrated DR-TB 6. Fast-track U-DST for all notied TB patients, module is not available in NIKSHAY. Also, while ensuring availability of diagnostics and the nodal DR-TB centers do not have access scale-up of laboratory capacity, including the to the patient related information and required LPA capacity, for implementation of district level data, which creates challenges the 2019 integrated algorithm in line with the to monitoring the progress of patients. envisaged scale-up of DR-TB diagnosis and • A nal challenge is linked to the reality of treatment. the rapidly evolving global landscape in 7. To ll access gaps, engage with the private regards to DR-TB diagnosis and treatment. sector network of laboratories for end-to-end The country needs to keep pace with such operations (turn-key model) including global developments and the changes specimen collection, transportation, reex rapidly fed into the country’s national sequential testing as per national algorithm, policy, medical education and health testing for pre-treatment evaluation and systems, with timely dissemination to all providing reports with timely TAT for patient relevant providers. management, in line with the STCI. RNTCP can learn from the experience of NACO on the Recommendations outsourcing of viral load testing to private 1. The RNTCP to conduct a study to better sector laboratories. understand the drivers of the DR-TB epidemic 8. Ensure uninterrupted availability of quality in India. Whole genome sequencing should assured SLD, including pediatric formulations, be applied appropriately to support said study “new” drugs and regimens, and repurposed and surveillance activities. drugs, in the public and private sector, using
80 domestic funding. Perform frequent f. Assessing implementation of aDSM forecasting and quantication exercises at activities and revising guidance on aDSM least for six monthly procurement planning as required. Use of modern technology to which needs to be supported by frequent strengthen peer-led learning and decision- assessment (once in two months) of drug making mechanisms of the management consumption trend and SLD stocks in pipe- of adverse events in DR-TB patients during line. treatment. 9. Ensure quality of local drug procurement g. Strengthening the linkages between the mechanisms, including urgent hiring of in- routine service facilities and the network of country agent. specialized referral centres for surgical 10. Initiate in-country discussions regarding intervention, management of DR-TB in licensing under the Patents Act of the “new” EPTB DR-TB with co-morbidities, Pediatric drugs (e.g., BDQ and DLM), allowing for TB, etc. generic manufacture and supply, and for h. Widen coverage under Ayushman Bharat reducing prices and improving access. to include TB patients requiring 11. Ensure strict adherence and monitoring of hospitalization for longer than 24 hours. Schedule H1 drugs. Consider prescription i. Two-year post-treatment follow-up of audits from the private sector. successfully treated DR-TB patients to 12. Introduce quality improvement tools to detect relapse at an early stage. monitor and ensure quality of care, to include: j. Expedite DR-TB module integration into a. Conducting urgent situational assessment NIKSHAY, grant access to NIKSHAY to of the decentralization of DR-TB care, and nodal DR-TB centres, ensure optimum use taking appropriate actions as identied to of NIKSHAY for monitoring of patient complete this process and subsequently management. monitor activities. 13. Prioritize introduction of new drugs and/or b. Clearly outlining the work functions of each regimens for DR-TB treatment via feasibility level of DR-TB care management, ranging and/or implementation assessment under from peripheral centres to nodal DR-TB programmatic conditions (i.e., “Deploy, centres. Evaluate, Adapt and Scale-up”), with the c. Tracking, monitoring and supporting priority on building the evidence base for an all patients, both in the public and private oral shorter treatment regimen for DR-TB sectors, from timely diagnosis (including patients. provision of required DST), prompt 14. Pilot/conduct operational research for LTBI initiation of the optimal treatment treatment among contacts of conrmed DR-TB regimens, to completion of treatment with patients. appropriate follow-up during and after 15. Use the in-country opportunities to learn from treatment. the best practices from the different states and d. Introducing quality improvement tools to districts: monitor and ensure quality of care for a. Provision of free diagnostic services via the patients. This should include an NHM “Free Diagnostics Initiative” – it assessment of the quality of supervision by should be expanded to cover the tests the RNTCP supervisory staff. required for pre-treatment evaluation and e. Considering additional nutritional support follow up of DR-TB patients through the public distribution system. b. First Referral Units through NHM – could
81 support pre-treatment evaluation implementation of new regulations, c. Community engagement legislations, gazette notications, and policy d. Best practices from BDQ-CAP project recommendations being released from time to time by the programme. i. Engagement of PVPI for aDSM ii. Monitoring and follow-up Key Messages iii. Dissemination of drug safety nding 1. Signicant achievement at the policy level but among physicians challenges remain at the implementation e. Availability of e-platforms such as the level, especially regarding quality of care for ECHO platform and peer-led learning and the DR-TB patients. decision-making mechanisms. 2. Human resource shortages and development 16. Convene regular national level deliberations are cross cutting issues. on evidence-based recommendations by 3. The DR-TB landscape is rapidly evolving - the WHO and other international bodies for country needs to keep pace uniformly with inclusion in the national PMDT guidelines – global developments and the changes fed create recommendations as a “living timely into the country’s medical education document” to enable the timely review and and health systems updates of selected sections as new evidence becomes available, and make these available 2.4.3 Comorbidities and Childhood to the country’s health and education systems, to be disseminated widely, implemented, and Tuberculosis monitored. In the WHO’s Global TB Report 2019, the gure 17. Document and disseminate the RNTCP’s below is used to illustrate the TB co-morbidities as PMDT related experiences by publishing related to SDG indicators. The report also goes on information that can be referenced and to breakdown the number of TB cases attributable shared with the broader global community. to the top ve risk factors: HIV, Diabetes, Smoking, Harmful Alcohol Use, and Undernourishment 18. Consider the establishment of an additional (Figure 35 and 36). monitoring cell at National level to monitor the
Figure 35: Indicators in the SDGs associated with TB incidence
Source: WHO Global TB Report 2019
82 Figure 36: Number and percentage of TB cases Attributable to Five Risk Factors, India 2018
The NSP 2017-25 lists a number of key strategies on addressing TB co-morbidities (see text box below).
Key strategies for co-morbidities in NSP (2017-25). Implementation frameworks
National framework for collaborative TB-HIV activities-2013, updated for upfront CB-NAAT- 2015
Four-pronged strategy on TB/HIV focusing on prevention, early diagnosis & treatment, Supervision & monitoring & implementation in special situations -Colocation of diagnostic & treatment centres -Upfront use of CB-NAAT for PLHIV -Daily FDC for Anti-TB treatment -H prophylaxis therapy -Single window delivery of TB and HIV services
National Framework for joint TB- Diabetes collaborative activities-2017 National Framework for joint TB-Tobacco collaborative activities-2017
Guidance document: Nutritional care & support for patients with TB in India- 2017
Guidance document on TB-HIV Linkages for Targeted Intervention (TI) & Link Worker Scheme- 2018
Guidance document on HIV & TB intervention in Prisons and other Closed Settings-2018
Framework for collaboration with Ministry of Social Justice and National Drug Deaddiction Programme under MoHFW (planned)
83 Achievements The program has made signicant strides in implementing activities (Table 11).
Table 11: This is a list of indicators that shows the percentage achieved against the targets set in the NSP.
• Collaborative frameworks for TB and • Efforts are underway to reach key priority comorbidities (TB/HIV, TB/DM, populations through targeted TB/tobacco, TB/nutrition are in place, with interventions. the framework on alcohol and drug addiction outstanding. Challenges and Opportunities • There has been a steady increase in uptake TB/HIV: of collaborative activities – with particularly • Persisting high TB/HIV mortality rate (12 impressive gains on HIV-associated TB percent compared with 3 percent of all new resulting in an 84 percent reduction in and relapse TB patients from the 2017 mortality since 2010. cohort) and late presentation of PLHIV to • Single window services for TB/HIV have care (average 150 CD4 cell count on been rolled out within ART centres, CB- enrollment, Agra) (Figure 37). NAAT rolled out as the rst TB diagnostic • Plans to adopt WHO recommendations on test for PLHIV and 99DOTS ICT adherence lateral ow urine lipoarabinomannan rolled out for TB/HIV patients. assay (LF-LAM) is an opportunity to • 73 percent of DMCs are co-located with incorporate latest 2019 WHO diabetes screening facilities. recommendations on LF-LAM and scale- • Nutritional support through nancial up nationwide. incentives for all patients in all States and • Ongoing HIV mortality audits should in-kind schemes provided in 16 states provide further information on TB/HIV (mainly for DR-TB patients and patients deaths including reasons for mortality. from poor areas).
84 Figure 37: Trends in the treatment outcome of TB/HIV patients from 2010 to 2017.
• Continued gaps in cascade from TB screen facilities/districts) and long turnaround to diagnosis among people attending HIV time from sample collection to treatment care (Figure 38). start reported (two weeks). Just over three • Inconsistent knowledge of the “4S” TB quarters (22042/28544) of new and symptom screen among staff and patients relapse cases diagnosed in 2018 were with interviewed in ART clinics. GeneXpert. • Plans to strengthen QI by RNTCP and Figure 38: The TB cascade of care National AIDS Control Program (NACP). among PLHIV. • Multi-disease platform facility of CB-NAAT supporting strategic placement in all ART centres/PPTCT clinics for early infant diagnosis of HIV, HIV viral load monitoring and viral hepatitis. In this context, it is crucial to continue to assess the need for new modules to meet these diverse laboratory diagnostic demands. • Limited coverage and/or reporting of HIV testing and ART services among TB patients in private sector (UP: 14 percent known HIV status and 8 percent of ART coverage in 2018) • Partnership guidelines/MOUs with NACP could be more conducive to encourage HIV testing by private practitioners and diagnostic facilities. • Area for strengthening data linkage • Limited CB-NAAT access (in particular for between ART services, NIKSHAY and PLHIV attending the 39 ART centres that are private sector. linked to CB-NAAT sites in other • ART services are still centralized, including
85 drug distribution, particularly in states that • Health and Wellness Centres under do not have a high burden of HIV. Ayushman Bharat provide an opportunity • 36 percent coverage of ART among TB for ART decentralization. patients reported through NIKSHAY in the • Plans for integration of data systems of public sector at district and state levels both programmes (UP), although high coverage reported by • Room to expand coverage of TB/HIV NACP – reconciliation of ART data at interventions among high risk groups and district or state level, limited. key populations (Figure 39). • Plans for further decentralization of ART services and for differentiated service delivery - opportunity to promote further decentralization of ART to CHCs at sub- district level in states not deemed high HIV burden.
Figure 39: TB cascade of care among prison inmates and HRGs.
• HIV testing among people with • The policy on HIV testing among presumptive TB in the public and private presumptive TB patients is in place and the sector is only implemented in two thirds of RNTCP and NACP plan to scale up across districts and coverage in these districts is the country. limited. • Unavailability reported for certain key • Studies in India show as high a yield of HIV drugs, such as cotrimoxazole, pyridoxine testing among people with presumptive TB and rifabutin for PLHIV on second-line as among people with conrmed TB. ARVs.
86 • Linkage of procurement, supply and comorbidities for diabetes (including management (PSM) systems. blood sugar values), tobacco cessation, • Lack of systematic joint planning and baseline nutritional status in TB patients limited capacity to conduct regular joint (Figure 40). This was evident from TB/HIV supervision. NIKSHAY in public and even more so in the • Parallel data systems for TB and HIV, whilst private sector. Opportunities: transitioning from paper-based to • Building on the TB/HIV scale-up electronic, requires staff to complete experience, consider targeted approach multiple formats, including for informed by mapping of joint/multiple comorbidities – resulting in short-cuts, burden to scale up activities. poor quality and data on comorbidities not • Plans for cross-ministerial collaboration to always captured in both systems. enhance food security and scale up • Plans for integration of data systems community-based nutrition interventions. • Plans for unique patient identiers • Plans for incorporation of nutritional screening and counselling as part of Other comorbidities: NIKSHAY mobile application • G a p s i n t h e c a s c a d e o f T B / • Plans to establish linkages between call noncommunicable disease (NCD) co- centres and tobacco and TB programmes morbidity screening and co-management. to enable counselling support, and for TB and DM management services. • Low coverage and/or reporting of screening with high drop-off rates for referral or co-management of the
Figure 40: Screening of TB patients for potential co-morbidities (i.e. blood sugar, tobacco usage, alcohol consumption).
87 • Suboptimal implementation/ placement of CB-NAAT for multi-disease documentation/monitoring of TB screening testing in all clinics providing ART and in diabetes services (6 percent), Tobacco prevention of parent to child transmission cessation centres (outside of the 16 districts services. where there are focused interventions and 4. NACP and RNTCP to continue roll-out of co- screening rates are reported to be 100 located, integrated TB and HIV testing and percent), and nutrition rehabilitation treatment services, through select PHC/CHC centres). and Health and Wellness Centres under • Ongoing plans to strengthen QI by RNTCP Ayushman Bharat at sub-district level, while • Coordination mechanisms and joint ensuring access to at least one district “Single supervision mechanisms need to be Window Service” in districts not qualied as established or strengthened for diabetes, high HIV burden districts. Both NAP and tobacco, alcohol across all States and RNTCP must strive to strengthen universal Districts. screening services for people with HIV and • Plans to strengthen collaboration through people with TB. setting up TB-comorbidity committees at 5. RNTCP, NACP and National Programme for national, state and district levels. Prevention and Control of Cancers, Diabetes, • Screening for depression/anxiety among Cardiovascular Diseases and Stroke MDR-TB patients not routinely conducted. (NPCDCS) to conduct joint surveillance of the joint/multiple burden of TB, NCDs, and HIV • While counsellors are in place for MDR-TB and, building on experience of scale-up of patients, capacity to screen for depression, TB/HIV activities, identify most at-risk anxiety and mental health conditions was populations (age, sex, geography and special limited. populations) and set targets to drive scale-up • Planned scale-up of the Framework for of collaborative action. collaboration with the Ministry of Social 6. RNTCP, NACP, NPCDCS and National Tobacco Justice and National Drug Deaddiction Control Programme (NTCP) to put in place programme under MoHFW provides an mechanisms that facilitate the implementation opportunity to scale up screening for and recording and reporting of screening and mental illness also. co-management of HIV, diabetes, tobacco • Parallel data systems for TB and NCDs - no and alcohol use and malnutrition in TB linkage between the data systems for TB patients, notied by private providers. and NCDs, resulting in difculties in 7. RNTCP, NACP, NPCDCS and NTCP to increase reconciliation of data and in understanding capacity to conduct joint monitoring and the true joint burden. supervision, and introduce quality improvement Recommendations measures for TB and comorbidities across the 1. RNTCP and NACP to urgently address cascade of screening, diagnosis, care and shortages of cotrimoxazole, rifabutin, and prevention services in both public and private pyridoxine and put in place measures in 2020 sectors. to improve forecasting and procurements to 8. RNTCP, NACP, NPCDCS and NTCP to avoid drug shortages. collaborate to link information management 2. RNTCP and NACP to adopt and scale up LF- systems with the same unique identiers to LAM guidelines (WHO 2019) as part of the ensure integrated case-based management advanced disease package of care for PLHIV. and pharmaco-vigilance, integrated 3. RNTCP and NACP to consider strategic procurement and supply management of
88 commodities, and systematically phase out for collaboration with the Ministry of Social paper-based systems. In the interim phase, Justice and National Drug Deaddiction parties to strengthen recording and reporting programme under MoHFW, strengthen the of collaborative activities, including data capacity of counsellors and personnel selected reconciliation at clinic, district and state levels to deliver drug and alcohol screening activities in both public and private sectors. to deliver screening and counselling for 9. RNTCP and NACP to continue efforts to scale mental illness also. up collaborative TB/HIV activities within targeted interventions and to this end, Key Messages systematically engage and build the capacity 1. Understand the burden of TB and co-/multi- of networks of PLHIV to assist in collaborative morbidities, set targets and take integrated action. action to scale. 10. RNTCP, National Viral Hepatitis Control 2. Understand the cascade and linkage gaps, Program (NVHCP) and NACP to consider and barriers in accessing care, and work assessment of joint burden of TB and viral across the health system and with communities hepatitis and leverage the collaborative to improve quality of delivery and recording TB/HIV platform to incorporate targeted and reporting of integrated services in both integration and referral of services for public and private sectors. screening and management for viral hepatitis among TB patients as and where deemed 3. Continue the momentum of decentralization necessary. of ART services and colocation of TB and HIV treatment to sub-district level to allow more 11. RNTCP and NACP to conduct operational patient-centred care for patients with HIV- research to a) identify root cause of high associated TB. TB/HIV mortality during TB treatment, b) to conduct patient pathway analysis for TB and comorbidities and c) include comorbidities 2.4.3a Childhood TB within a catastrophic patient cost survey. India is among one of the countries with the highest 12. As part of plans for scale-up of the Framework burden of TB where about 342,000 incident cases of pediatric TB are estimated to occur every year
Figure 41: National trends in pediatric TB case reporting.
Trend in Reporting of pediatric TB cases
89 accounting for 31 percent of the global burden. implementation of DOT, family members are The case detection rate in India for children is 39 being trained and empowered to serve as percent. The country has wide geographical treatment providers for children with TB. variation in the TB epidemic with the magnitude • Launching a scheme of providing monthly several local epidemics remaining hidden due to nutritional support as part of the NPY in 2018 inadequate data and surveillance systems. This with the aim of addressing the high proportion indicates the potential for missed cases particularly of malnutrition among TB Patients. A digital from most privately-treated patients. payments infrastructure via accountable electronic benets transfer is being expanded Achievements for all TB patients. The following section describes summaries of • Updating the current RNTCP Pediatric TB observations as per the 4 pillars of the RNTCP Guidelines (2019) that recommends Bacillus Calmette-Guerin (BCG) vaccination for all Build: newborns under the universal immunization Recognizing the need to address the burden of programme; rapid molecular testing for TB childhood and adolescent TB, India has instituted a diagnosis of childhood and adolescent TB; series of strategies in the TB NSP (2017-25) cost-free child friendly daily drug formulation; including: and extensive TB preventive therapy for at-risk children. • Establishment of a focal point and a national Childhood TB working group with terms of • Notication of TB among children varies reference and representation from academics, across states with a range of ve to eight practitioners, and other stakeholders. percent (expected is more than 10% of total TB) indicating underreporting and • Development of Pediatric TB guidelines for use underdiagnosis (Figure 42). by public and private practitioners with a plan for evaluation of implementation in 2021. Figure 42: Progress in the number and • Roll out of the national digital information percent)among total TB) of pediatric TB Patients system (NIKSHAY) for recording, reporting and monitoring of TB related information for prevention and care as well as monitoring drug supply chain management. • Increased engagement of the private sector providers. The RNTCP works with the Indian Academy for Pediatrics for the development and updating of pediatric TB guidelines and building capacity for pediatricians and medical ofcers. Private pediatricians and Prevent: other care providers treating TB in children are The JMM team identied the following in reviewing also engaged and able to contribute to the TB the current implementation of prevention notication system. methodologies: • Engagement of community health workers is • Contact investigations - mainly widely practiced through structures such as implemented through engagement of Rashtriya Bal Swasthya Karyakarm (RBSK) for community volunteers (incentivized) but contact screening, referral of samples for CB- also carried out at health facilities. The NAAT, referral of symptomatic cases, and community volunteers apply the treatment support. To advance the
90 symptomatic screening criteria to refer been included in the programme. suspected cases to the referral network However, due to limited capacity of health while keeping registers. They also provide care providers and lack of point-of-care support for treatment - providing TPT for non-sputum based sensitive diagnostic eligible children. tests for children, TB is often missed or • BCG vaccination is carried out by a diagnosed very late. universal immunization programme with a • CB-NAAT is being offered free of charge national coverage of 92 percent. for diagnosis among children with • No AIC interventions practiced in public or symptoms suggestive of TB. Over 1.6 private facilities. There is also indication of lakhs presumptive TB cases were tested in low awareness of infection control practices 2018 under the programme. However, (e.g., routine use of cough etiquette), use of testing is limited due to inadequate inadequate protection of children and capacity of HCWs to identify presumptive family members or close contacts in TB in children and to collect samples using households or community settings where gastric lavage. open TB cases including MDR cases cohabit • CXR is available at hospitals but is (see text box). underutilized for diagnosis at health facilities. Children suspected of TB are Stories from the Field often not referred for CXR. A community health worker who spoke with the • Weak integration with other programmes JMM team members relayed the story of a family (e.g., MCH, HIV, nutrition, others) limits the who had multiple cases of childhood TB. Patient potential for early detection of TB cases 1 was an 18-year-old diagnosed with TB. One though the potential for comorbidities is year later, Patient 2, the younger (16 years old) very likely. sibling of Patient 1 was diagnosed with TB. Then Treat: three years later, Patient 3, the mother of Patients The JMM team observed the following in the 1 and 2, was diagnosed with TB. The community implementation of childhood treatment regimens: health worker noted that she had provided care for all three family members through treatment • The national childhood TB working group support. Though there is a chance for new works closely with the TB programmes with infection from multiple sources which could have dened TORs and has developed pediatric caused the subsequent infection in the other TB guidelines to be used at both public and family members, this case may also highlight the private facilities. potential gaps in AIC which allows the • Though training sessions on childhood TB transmission to continue for years within the are conducted at regular intervals, the same family, or missed opportunities for early reach and scope of the training is outpaced case detection, treatment, and prevention. by the demand and need. • There is limited capacity of child health care providers, especially at the peripheral Detect: levels of the health delivery system. Given The JMM team identied the following in reviewing the challenge in early detection and quality the detection methods in childhood TB: of care, studies show that children with TB • In order to enhance case nding, novel present late in the course of TB disease methods of sample collection such as resulting with high mortality (see text box). gastric lavage and induced sputum have • New child friendly avored dispersible
91 formulations of daily FDCs have been Survival and predictors of mortality in implemented across the country since childhood TB cases in a tertiary referral January 2018. However, the supply of TB hospital these drugs is not consistent and stockouts have been reported in some states. In In a retrospective study on mortality in childhood addition, Cotrimoxazole Preventive TB in a tertiary referral hospital, researchers Therapy (CPT) and pediatric formulations found that out of a total of 2163 admissions, for MDR-TB are not routinely available. 1380 patients where childhood TB cases (under Reasons include delay in procurement and 15 years of age) requiring admission. A total of regulatory issues in the process of approval 74 of those childhood TB admissions resulted in of use of drugs for pediatrics. death with a mortality rate of 5.36%. Of the 74 deaths 43 (58.1%) occurred in the rst week of Stories from the Field admission out of which 7 (9.4%) deaths occurred During a eld visit, the JMM team that visited on day 1, 9 (12.16%) deaths occurred on day 2 Chhattisgarh met with a 19-year-old who was while 28 (37.84%) deaths occurred from day 3 to treated for TB two years ago and completed 7 of admission to hospital. The study highlights treatment. When discussing his educational the importance of early diagnosis and timely status, he reported that he had dropped out of treatment to reduce mortality. school two years ago when he was rst diagnosed with TB. When asked why he did not Source: Prof (Dr) Sangeeta Sharma, Head of return to school upon completion of his Pediatrics, National Institute of Tuberculosis and treatment, he noted that he did not feel Respiratory Diseases, Sri Aurobindo Marg, New comfortable when people spoke about his illness Delhi, India and he felt that his friends do not want to spend time with him anymore. The conversation • Inadequate number of trained healthcare highlights the need to address issues of stigma workers for quality pediatric TB care. and discrimination in children and adolescents with TB through age-appropriate psychosocial • Suboptimal involvement of private sector in support to ensure school enrollment and better addressing pediatric TB burden. TB treatment outcome. • Lack of childhood TB specic advocacy, communication and social mobilization (ACSM) activities Challenges and Opportunities • Inadequate representation of children and Build: adolescents in operations research • There is a paucity of targets and indicators for child and adolescent TB. Previous Prevent: surveillance activities excluded children thus • Contact investigations not routinely no comprehensive data to inform planning implemented. and programming targeting specic needs • Inadequate integration or linkages with of children and adolescents with TB. other programmes (MCH service • Lack of comprehensive data on contacts platforms, HIV, nutrition, others) leading to investigations/reverse (or source) contact missed opportunities for screening. investigations, prevention, and treatment • Inadequate infection control measures at follow-up. There is a poor linkage of health facilities and within households. records (child & family index case) to facilitate decision cascade for screening/ • Sub-optimal completion rates of TPT- H and care. chemoprophylaxis (six months).
92 Detect: a. Sensitive point of care diagnostics (non- • Inadequate HCWs capacity to suspect, sputum based). investigate and diagnose child TB cases. b. Validation of newer drugs/regimens and • Difculty in obtaining samples from vaccines. younger children leading to under- c. Paediatric TB care models. diagnosis. d. Effect of TB–related stigma and discrimination • Lack of sensitive diagnostic tools for on children and adolescents with TB. children; often TB is missed or diagnosed very late. Prevent • Limited access and use of diagnostic 8. Strengthen contact tracing and reverse contact services (e.g., chest x-ray available only in tracing with decision cascade for recording, hospitals) suboptimal use of Xpert TPT and follow-up and tracking. diagnostic tests for extra-pulmonary TB. 9. Urgently operationalize the guidelines for LTBI treatment to all eligible beneciaries. Treat: 10. Training and provision of supplies for • Lack of holistic and age-appropriate implementation of AIC measures at quality care of the child and adolescent household, community, and health facilities. with TB • Inconsistent supply and unavailability of Detect child-friendly formulation for TB (MDR drug 11. Expand screening at entry points (e.g., NRC, for pediatric treatment not available, CPT MCH programmes, IPD/OPD, school). availability is inconsistent) 12. Link records of family for contact/reverse contact Recommendations tracing and decision cascade for early identication for treatment/prevention and tracking. Build: 13. Increase access and use of CXR for pulmonary 1. Prioritize activities to meet the specic needs of TB and leverage Xpert tests for EPTB (e.g., for childhood TB in planning, programming, and clinical specimens to diagnose TB lymph node funding. disease). Consider options for outsourcing a. Consider developing a national roadmap supporting services (e.g. Hand holding by for childhood and adolescent TB. COE Tele radiology, AI). 2. National inventory studies to assess the extent 14. Build the capacity of staff by holding preservice of under-reporting. and in-service training using different systems 3. Case-based surveillance disaggregated by (e.g., e-platform, ECHO). Consider using age (ideally 0–4; 5–9; 10–14; and 15–19 selected institutions as centres of excellence for years). paediatric TB to build core capacity for trainers 4. Set national child and adolescent TB targets. and cascading of targeted training to all levels. 5. Strengthen advocacy and awareness through Treat developing and dissemination of childhood TB specic ACSM materials. 15. Ensure quality of care for TB in children and 6. Ensure psychosocial support including adolescents. Consider a differentiated service education for school age children and model in line with quality improvement to meet adolescents with TB. the specic needs of children and adolescents with TB. 7. Promote and support priority research areas:
93 16. Implement guidance for escalation of care to a include weak contact tracing, limited capacity for specialist. case detection, lack of sensitive point of care 17. Ensure the availability of isolation beds for diagnostics and inconsistent availability of child seriously ill and MDR-TB. friendly anti-TB drug formulations. In addition, the 18. Employ the use of treatment support gap in surveillance data to inform the national mechanisms (e.g., education, psycho-social, burden of TB hinders the ability to target and training of the treatment supporter). measure outcomes of age appropriate interventions for childhood and adolescent TB. It is 19. Fast track child friendly TB formulations for therefore critical to ensure that the NSP includes MDR-TB and TPT. targets and indicators informed by local data including inventory TB surveillance for children and Key Messages adolescents. As TB in a child indicates ongoing There is remarkable commitment and notable transmission and missed opportunities for progress in TB elimination efforts with important prevention it is important to prioritize children to policy and strategic directions for addressing achieve the goal of TB elimination in India. childhood TB. The most pressing challenges
94 3. Annexes
3.1 State Level Reports 3. Ensure sufcient human resources to commensurate with current, and expanded TB 3.1.1 Assam Elimination activities; enhance workforce (both State Visit technical and administrative), build capacity, supportive supervision to produce a safe, The Assam State team visited two districts: Kamrup skilled and motivated workforce. Metropolitan and Tinsukia. Below are key ndings 4. Build and utilize technical support mechanisms from the various sites visited. at State- and National-level partnerships, including the private sector. Key Observations: 5. Scale-up innovations for success, leverage • Assam ranks second in State TB Index teleradiology, integrate community Scoring amongst medium size states; State engagement via TB Champions, TB forums; demonstrated initiative to adapt the same strengthen partnerships with private index for scoring their districts. laboratories, corporate hospitals, industry • Assam has targeted three districts (Dima (e.g., tea estates, coal and oil companies). Hasao, Goalpara, and Majuli) for Ending 6. Improve private practitioner’s engagement to TB. nd, prevent, treat and care for all persons • Community, primary health system, and suffering from TB through increased nancial private sector engagement for TB outreach support and coordination. and collaborative projects. 7. Leverage the general health system and • TB Champions, schools and media Panchayati Raj Institutions – challenge them to engaged in social mobilization and achieve TB Free Villages, Blocks and Districts. community awareness. 8. Accelerate administrative processes for • Best practices – JEET, teleradiology, approving and disbursing expenditures; outsourcing of key services by NHM benets and enablers need to be passed on to (clinical, laboratory, pharmacy) observed; treatment supporters and patients in a timely but RNTCP needs coordination with the manner; leverage key stakeholders to improve NHM initiatives, and systematic scaling up. access to direct benet transfer (e.g. banking sector, Indian Postal Service). Recommendations: 9. Engage multiple sectors and leverage existing 1. Acknowledge the Prime Minister’s call to End systems for nutritional, social protection, TB by 2025, by formally declaring “Assam TB community support and counselling services; Free Mission” through a well-articulated, (i.e., focus on ACSM activities that promote costed TB Elimination plan (e.g., Bihar, proper cough etiquette, adequate ventilation, Chhattisgarh, Himachal Pradesh, Kerala, and the discontinued use of solid fuels for Sikkim, Tamil Nadu). indoor cooking). 2. Develop and implement a State TB Elimination 10. Upgrade and maintain high-quality Plan under the patronage of the Chief Minister infrastructure for TB services at the State and to coordinate, implement, and monitor the District TB Centres, renovation of the State plan. Include a comprehensive, evidence- Warehouse, expand the diagnostic network to based, and well-funded plan to accelerate include private laboratories and facilities; activities to End TB. strengthen processes in Medical Colleges.
95 Utilize the facilities already available at the NOTIFICATION, REPORTING AND Department of Microbiology at Assam Medical RECORDING College (i.e., culture and drug susceptibility During the rst ten months of 2019, 3878 TB testing; rst- and second-line LPA); expand the patients were notied (n=3007, 88 percent public laboratory network for culture and drug sector; n=871, 22 percent private sector). A trend susceptibility testing to include the Department for increased notications has occurred since 2015. of Microbiology at Silchar Medical College. In 2018, public sector notications doubled, and 11. Engage medical colleges and corporate private sector notications tripled from the previous hospitals to enhance notication, expand year (2017). Treatment success rate has a stable services to vulnerable populations, children, trend amongst new (87percent, 2019) and extrapulmonary TB, MDR TB, non- previously treated (81percent, 2019) patients in the communicable diseases (e.g., malnourished, public sector; and 49 percent amongst new patients diabetics, psychiatric illnesses, and persons in the private sector. A minority (33 percent) of who abuses substances and alcohol), and notied patients in the public sector have environments that exacerbate TB (e.g., indoor documented HIV status; however, testing is readily pollution). available. Few patients in the private sector have documented HIV status, and testing is not routinely conducted in the private sector. The vast majority of Kamrup Metropolitan District notied patients with known HIV status were tested in the public sector. Since October 2018, 58 TEAM MEMBERS percent of the eligible patients (n=3640) and 1 Dr. Mukta Sharma (District Lead), Dr. Umesh (0.14 percent) of the registered private providers Alavadi, Dr. Reshu Agarwal, Dr. Avi Kumar Bansal, (n=68) have received cash transfers. However, 69 Ms. Deepti Chavan, Dr. D Deka, Mr. James Malar, percent of the eligible treatment supporters (n=20) Ms. Miruna Mosincat, Dr. Bhavesh Modi, Mr. received DBT during the same period. NIKSHAY Andualem Oumer, Dr. Anil Jacob Purty, and Dr. was readily available and used by all RNTCP staff. Sangeeta Sharma. Most staff used the mobile phone application or the RNTCP supplied tablets. NIKSHAY was utilized for BACKGROUND real-time reporting and recording of key variables Kamrup Metropolitan District (KMD) is one of 33 (e.g. name, age, sex, address, treatment start date, districts in Assam. The district is largely composed laboratory results). The use of NIKSHAY for real- of the city of Guwahati and has an estimated time treatment adherence documentation was population of 1,393,612 (1,528 km2) – the largest lagging and, in most instances, delayed by up to urban population in Assam, and northeast India. one month. Guwahati is considered the “gateway to the northeast” as a major transportation hub for PREVENTION commerce and tourism. KMD is one of the fastest growing locations in India; with nearly 19 percent TPT initiation among PLHIV was approximately 60 population growth rate over the past 10 years. The percent, with 85 percent completion rate. TPT for literacy rate of the district is high (88 percent). KMD household children under 6 was observed and is prone to seasonal ooding (April through available; however, due to lack of systematic October), especially low-lying areas adjacent to the contact investigations (25 percent of eligible index Brahmaputra River, due to poor drainage systems patients investigated) the proportion of eligible in the city. children receiving TPT is low. We found no evidence of TPT (implemented or otherwise planned) in other high-risk groups or among adult household contacts. AIC awareness and
96 implementation in the general health system was CBNAAT, rst- and second-line LPA). Moreover, the lacking, and there is no routine TB screening of IRL is experiencing multiple resource constraints healthcare workers. There was a worrying number (i.e. aging equipment requiring maintenance, of healthcare workers (more than 5 ve), and TB limited supplies and reagents, fuel and most treatment supporters who became ill with TB in the notably, inadequate human resources) that are recent past, suggesting potential nosocomial adversely affecting the quality of service delivery. transmission. Fast tracking of symptomatic patients No agency was available for routine maintenance (i.e. four symptom screening) was observed in the of microscopes. An intensied focus on turn- community ART Centre, though the ART staff were around times was also noted, including the need to not aware of the TPT recommendations for all explore options for private sector outsourcing. ACF PLHIV. Generalized AIC at community health campaigns in the urban slums using a mobile CB- centers was not observed in outpatient NAAT machine occurred, but with a lower than departments, radiologic departments, and expected yield. During October 2018 to October laboratory/diagnostic departments. These areas 2019, 6793 people were screened in the slum were characterized by patients crowding in resulting in only nine diagnosed patients among congested areas. We observed no triaging or 244 sputa collected. Routine systematic household systematic processing for patients with potential contact screening is minimal. respiratory symptoms consistent with TB. DRUG-RESISTANT TB (DR-TB) CASE FINDING, DIAGNOSIS AND In 2019, 24 DR-TB patients were diagnosed; 14 (58 LABORATORY SERVICES percent) were initiated on BDQ-based treatment. The district has 13 DMCs and additional non-DMC In the public sector, 62 percent of notied patients health facilities are being converted into diagnostic received CB-NAAT testing. CB-NAAT utilization centers for CB-NATT. The district has three digital has increased in 2019 (i.e. averaging 400–500 radiology facilities, and one mobile radiology unit. tests per month); a 20 percent difference from Rapid rifampin-resistance detection (e.g. surrogate 2018. DR-TB patients were offered pre-treatment marker for MDR-TB) is available through CB-NAAT. investigations free of direct costs under the Chief The integrated DR-TB diagnostic algorithm with a Minister’s free diagnostic scheme. This program cascade of sequential testing (i.e. smear- has made signicant efforts to keep up with microscopy, CB-NAAT, LPA and culture) was being frequently changing national PMDT guidelines. DR- followed; and testing is free of direct cost to all TB care is decentralized and available at district DR- patients. In total, 1948 TB patients had valid CB- TB centers, but this was not observed in practice. NAAT testing for DR-TB; this represents DR-TB patients in outer districts often travel to the approximately 64 percent of all notied TB nodal state-based DR-TB center for the necessary patients. However, the yield may be improved by investigations and initiation of PMDT. No formal more focused case nding measures, and meeting of the DR-TB Committee has taken place improving the efciency of sample collection and for some time. Faculty of Guwahati Medical transport. In spite of the specimen transportation College and Hospital are not involved in treatment system being in place, substantial loss and delays in decisions of DR-TB patients receiving care at the appropriate treatment initiation occurred during nodal DR TB Centre. Real-time, DST-guided repeat sample collection and transportation. treatment is not fully implemented in neither the Currently, sputa are batched, presumably to reduce public nor private sectors. Follow-up supervision transportation cost. This practice was found to and monitoring of patients was also sub-optimal. negatively impact the time to diagnosis, and There was no mechanism for AE monitoring. There sequential testing required for second-line tests. were human resource constraints and NIKSHAY Leaks in the treatment cascade were observed; portal constraints for aDSM. specically, during sequential testing (e.g.
97 CO-MORBID CONDITIONS AND treatment literacy, condentiality and stigma were CHILDHOOD TB seen as potential threats. High out-of-pocket expenses for tests, accommodation and travel for We observed underdiagnosis and underreporting people needing TB treatment (and family of pediatric TB; two percent in KMD (four percent in members) and incentive payments being rejected Assam). Routine sample collection (e.g. gastric were observed. Engagement of local traditional lavage, ne-needle aspirate collection) and testing healers, industry (i.e. tea plantations, brickworks), from pediatric presumptive TB was not observed in political leaders, and the media was lacking. neither public or private sectors. High rates of TPT in children were reported within households PUBLIC-PRIVATE MIX (PPM) evaluated — noting that contact investigation implementation was suboptimal. The team noted In 2019, 22 percent of the total notications were good community awareness practices in private by the private sector; the majority by the Joint Effort health facilities, NGOs, and schools (e.g. for the Elimination of TB (Project JEET). We awareness was high in the school visited). Single observed strong coordination between DTC and window services for HIV and TB were observed; JEET; including initial mapping of all health care high visibility of TB in ART centers was noted. ART providers. Private sector treatment support is treatment rates in co-infected patients were over 85 available through JEET. A letter issued by the percent. However, HIV testing among TB patients is Deputy Commissioner has helped the district low. High mortality rates amongst PLHIV, and improve TB notication from private providers; advanced HIV clinical presentations were also supplemented by sensitization meetings for private noted, suggestive of delays in TB diagnosis and practitioners. Laboratories and pharmacists were treatment. Gaps in NIKSHAY entry for TB-HIV co- less involved in the PPM work, however. infected patients led to non-disbursement of NPY. The proportion of TB patients screened for diabetes HEALTH SYSTEM was 42 percent; however, screening of TB among Policies, guidelines, regulations, program diabetics was not seen. implementation plans, organizational structures are available. Integration of TB services in urban COMMUNITY ENGAGEMENT AND health facilities was observed within a well-dened PARTNERSHIPS and rational hierarchy of RNTCP services delivery systems. National and donor funding is available; Partnerships were visible across all sectors, and this including district-level increases in procurement was seen as an area of strength. The s maintains and infrastructure investment (e.g. LGB Chest multisector partnerships with a wide range of Hospital, Guwahati). FDCs, and SLDs are provided stakeholders; including AYUSH providers, tribal free of direct cost. Available information populations, the Indian Military Branches, the India management systems included NIKSHAY, NIKSHAY Railway, various NGOs, and private health Aushadhi, and TB LIMS; however, there was limited institutions. TB Champions are trained, engaged, interoperability of these systems. There are and condent. Public awareness campaigns duplicative systems of recording information; appeared accurate, visible and high prole (i.e. maintaining both paper-based and electronic community meetings and campaigns). There is records. Connectivity to NIKSHAY is inconsistent; engagement of media actors (i.e. print, radio, TV, resulting in delays for entry of data. There is good online). However, these successes were storage conditions and adequate space at the relationship-dependent, more can be done to district, IRL and health facility levels. Availability of systematize them at an institutional level; this drug quality-control mechanisms at state level; requires high-level negotiation at state and more than 100 drug seller’s licenses were national levels. Limited access to comprehensive suspended due to non-compliance with counselling including on mental health, nutrition,
98 regulations. However, the team noted a lack of Program and NCD through the State TB- ownership by the general health system (i.e. non- Comorbidity Committee. RNTCP workforce). There is underutilization of NIKSHAY by the general health system. A major Tinsukia District challenge is inadequate and de-motivated human resources (including contractual staff). Low salary, TEAM MEMBERS lack of health insurance, and inadequate training Dr. Patrick Moonan (District, and State Lead), Dr. and supportive supervision. Nascent investments in Vineet Chadha, Dr. Di Dong, Ms. Smirty Kumar, Dr. community systems for health were also noted. Shamim Mannan, Dr. Sreenivas Nair, Dr. Malik Parmar, Dr. Pirabu Ravanan, Dr. KS Sachdeva, Dr. S Overall, the JMM team members were of the view Somasekar, Dr. Sriram Selvaraju, and Dr. Palash that Kamrup has made signicant progress. Talukdar. However, opportunities for early diagnosis to interrupting the chain of TB transmission, and TPT BACKGROUND are still being lost; this can be avoided. There is a need for a clear branding and visibility of the End TB Tinsukia is a predominantly rural (91 percent of Program, beyond the TB facility. This will create population) district in the eastern most part of the awareness, generate demand, and reduce stigma. state of Assam, with an estimated population of 1.4 Visible political commitment and monitoring at all million (3790 km²). The Indian State of Arunachal levels of the administration will help to boost the Pradesh borders Tinsukia to the north and east; the morale of the program, support integration, and most eastern end of the district is 80 kilometers generate adequate investments in ending TB. away from the Myanmar international border. A substantial proportion of the population work and RECOMMENDATIONS reside within tea plantations, and are at high risk of TB due to poor living conditions (e.g. overcrowding, 1. Sustain the political and nancial support to the inadequate or no ventilation) indoor use of fossil TB program, go beyond the health sector to fuel for cooking, alcoholism, and poverty. increase multisectoral accountability. 2. Provide support/guidance to the TB program NOTIFICATION, REPORTING AND on systematic partnership and collaboration RECORDING with relevant stakeholders (education/railways/ armed forces/ private The total number of TB notications in the district sector etc.). has decreased from 3255 patients in 2015, to 2192 patients through the rst ten months of 2019. 3. Negotiate visibility for the “End TB” campaign An increased proportion of notications from the by supporting widespread awareness of TB private sector (13 percent to 26 percent) occurred outside the public sector health facility through during the same time period. Treatment success branding, media engagement (including rate of new and previously treated patients also social media). decreased since 2015 (90 percent to 69 percent 4. Support the uptake and utilization of GOI amongst new; 75 percent to 61 percent amongst subsidies and entitlements for TB patients, previously treated); presumably due to the treatment supporters and private sector by increases in non-evaluated treatment outcome streamlining payments from the GOI to status in the private sector. ACF is organized in beneciaries (patients, private sector providers collaboration with the various tea gardens, and etc.) and addressing the provision of payments also the district jail; however, the yield has been less to those who have no bank account (e.g. than one percent of all notications. Routine, homeless/no address proof). systematic household contact screening is minimal. 5. Strengthen coordination between the TB The majority of notied patients in the public sector
99 have documented HIV status, and testing is readily The district has ve digital radiology facilities, and available. Few patients in the private sector have one mobile radiology unit. All radiographs are documented HIV status, and testing is not routinely interpreted by contractual remote radiologists via conducted in the private sector. DBT was initiated tele-radiology; with a turnaround time of less than and progressively increased with time. During April 48 to 72 hours. At the district-level hospital (civil, 2018 to August 2019, 30 percent of the eligible secondary care), we scanned chest radiographs patients (n=4304) and 77 percent of the registered from patients who presented two days previously for providers (n=35) have received cash transfers. potential images consistent with TB. Among 17 However, none of the eligible treatment supporters chest images, there were 4 (24 percent) potential (n=303) received DBT during the period. NIKSHAY presumptive TB patients based on radiologic was readily available and used by all RNTCP staff. presentation; among these patients, only one (25 Most staff used the mobile phone application, or percent) was referred to the DMC for further RNTCP supplied tablets. NIKSHAY was utilized for evaluation using smear-microscopy or CB-NAAT. real-time reporting and recording of key variable This suggests that potential TB patients were missed (e.g. name, age, sex, address, treatment start date, or delayed in diagnosis. Rapid rifampin- laboratory results, HIV status). The use of NIKSHAY resistance detection (e.g. surrogate marker for for real-time treatment adherence documentation MDR-TB) is available through CB-NAAT. The was lagging and, in most instances, delayed by up integrated DR-TB diagnostic algorithm with a to one month. cascade of sequential testing was being followed; testing is free of direct cost to all patients. However, patients with CB-NAAT positive/rifampin-sensitive PREVENTION patients were not sent for rst-line LPA; this results in TPT initiation among PLHIV was 14 percent. TPT for missed diagnosis of H mono-resistant and poly- household children under 6 was observed and drug resistant patients. In total, 1948 TB patients available; however, due to lack of systematic had valid CB-NAAT testing for DR-TB; this contact investigations the proportion eligible represents approximately 64 percent of all notied children receiving TPT is low. There is no routine TB patients. However, the yield may be improved screening of healthcare workers for TB; at least two by more focused case nding measures, and healthcare workers have been treated for TB in the improving the efciency of sample collection and recent past, suggesting nosocomial transmission. transport. Currently, sputa are batched, Fast tracking of symptomatic patients (i.e. four presumably to reduce transportation cost. This symptom screening) was observed in the practice was found to negatively impact the time to community ART Centre, though the ART staff were diagnosis, and sequential testing required for not aware of the TPT recommendations for all second-line tests. As a result, there are delays (in PLHIV. Generalized AIC at community health some cases up to 30 days) in initiating effective DR- centers was not observed in outpatient TB treatment. Improper technique, measurement, departments, radiologic departments, and and concentration was observed for producing laboratory, diagnostic departments. These areas disinfecting solutions, nor was the disposal process were characterized by patients crowding in consistent with international standards. Thus, the congested areas. We observed no triaging or handling and disposal of biomedical waste (e.g. systematic processing for patients with potential CB-NAAT cartridges, Falcon tubes) were not safe respiratory symptoms consistent with TB. and appropriate for practice.
CASE FINDING, DIAGNOSIS AND DRUG-RESISTANT TB (DR-TB) LABORATORY SERVICES All DR-TB patients undergo free pre-treatment The district has 15 DMCs and additional PHIs are evaluation at the District PMDT Centre. This implies being converted into non-DMC diagnostic centers. all DR-TB patients must travel to Assam Medical
100 College, Dibrugarh to start MDR-TB treatment, and diabetes; we found no evidence that diabetic manage adverse drug events with subsequent patients were screened for TB. Excessive alcohol follow-up at the district DR-TB facility. The district consumption was noted as a major public health DR-TB facility has professional counselling services, problem in the community; as many as 85 percent and ECG available. There is only one public of the adult population consumes alcohol daily, and physician (Medicine)-specialist for TB in the entire approximately 20 percent are considered district, he is nearing retirement, and not trained in “alcoholics”. Professional psychological current policies for DR-TB management. The DR-TB counselling is available at the primary public health coordinator is well-trained, motivated, committed, center, and is used for TB treatment adherence, and demonstrated a good understanding of treatment for substance use (e.g. tobacco), national PMDT policies and practice. The DR-TB excessive alcohol use, and other psychiatric illness ward (one “isolation room”) at the district-level, (e.g. anxiety, depression, schizophrenia). Some tertiary care center has not been utilized to date. cross referrals were observed between the recently We observed this isolation room with inadequate established tobacco cessation program and ventilation and inappropriate AIC measures in RNTCP; however, this area needs further promotion place. To date, the district has started two patients and strengthening with enhanced training, on a BDQ-based regimen. However, there is a documentation and more regular coordination and need to strengthen local expertise for local supervision. (decentralized) DR-TB management, improvement in civil works of DR-TB ward, and increased services COMMUNITY ENGAGEMENT AND from private specialist consultants (e.g. PARTNERSHIPS pulmonologist, medical specialists) who are Collaborative partnerships were visible across all available in the district. sectors; this was seen as an area of program strength. The District NTP has engaged many of the CO-MORBID CONDITIONS AND large tea estates, oil companies, coal mining CHILDHOOD TB companies, non-government organizations and private sector health institutions in TB outreach, We observed underdiagnosis and underreporting care and treatment. DBT benets were available in of pediatric TB; 3.8% of all notied patients in all the tea gardens visited and for all the patients Tinsukia are pediatric TB (four percent in Assam). interviewed. Thirty-four (94 percent) of the private Routine sample collection (e.g. gastric lavage, ne- providers have received DBT. Out-of-pocket needle aspirate collection) and testing from expenses, especially for drug rell was observed, pediatric presumptive TB was not observed in and most DOT was facility based. It is common neither the public or private sectors. Nearly all practice for patients to present weekly at the health children with TB were diagnosed using clinical facility to collect their drug rell. Private industries presentation; in rare instances with radiologic (i.e. tea estates, oil and coal companies) have evidence. The majority (11 of 15; 73 percent) of the resources devoted to health and are willing to invest DMC are co-located with Integrated Counseling in TB elimination; this needs further formal and Testing Centers (ICTC); CB-NAAT laboratories exploration. Traditional healers were observed to are co-located with link ART centers. Among all be the rst point of contact in most rural settings; notied TB patients in 2018, 66 percent had a these healers should be formally engaged in the documented HIV status; albeit this is almost elimination strategy. exclusively from the public sector. CB-NAAT is available free of direct cost to all PLHIV, and cotrimoxazole prophylactic treatment is also HEALTH SYSTEM available for opportunistic infection management. Despite recent downward trends, treatment success All TB patients managed for TB were screened for and overall notications, the District TB team is
101 committed to delivering high-quality TB services. Teleradiology and outsourced lab services, Tea Estates’ medical services have committed “TB professional psychological counselling Free Garden” campaigns that fund TB screening available. and services to employees and their families; • Existing coordination between RNTCP and including free transportation of patients to a higher NTCP. level of treatment facility elsewhere (i.e. PMDT). These are “Models of Excellence” which have been RECOMMENDATIONS recognized at the State level (Ledo PHC). The 1. Ratify the “Intensied Action Plan to END TB by district has out-sourced some laboratory and tele- 2025” in Tinsukia; increase budgetary radiology services. Counselling provided by justication in the 2020–2021 PIP; engage all professional counsellors to TB patients. However, stakeholders and community in the “TB Free the team noted a lack of ownership by the general Tinsukia” Plan. health system (i.e. non-RNTCP workforce). There is underutilization of NIKSHAY by the general health 2. Expedite the recruitment and stafng of all system. Available information management vacant posts in the district (especially, STS and systems included NIKSHAY, NIKSHAY Aushadhi, district accountant to accelerate payment and TB LIMS; however, there was limited processing and approvals to ensure timely interoperability of these systems. There are contract payments and DBT payments). duplicative systems of recording information; 3. Expedite training (and refresher training) to all maintaining both paper-based and electronic staff in all categories: including RNTCP staff records. Connectivity to NIKSHAY is inconsistent; (DTO, PMDT Coordinator, TB-HIV resulting delays for entry of data. There are various Coordinator, STS, STLS); Medical College health system-level integration programs (e.g. faculty and staff; DR TB physician-specialist, PMJAY, psychological counselling, smoking session and other civil hospital physicians and non-communicable diseases). Some of the (pediatricians, medical ofcers) general health hospitals involved in TB treatment and care are staff; PHI medical ofcers, ANMs, MPWs, integrated with PMJAY; however, these facilities CMEs for PPs. have not sent TB-related claims to PMJAY. TB 4. Harness nancial and material support from program remains vertical and key positions remain Coal India and private Tea Gardens for TB vacant. For example, the lack of nance staff has diagnostic services implementation (CSR funds led to delays in payment approvals and processing may be tapped); formalize a partnership contracts and DBT. Moreover, there is an mechanism. immediate need to address low salary, lack of 5. Conduct systematic contact investigations for health insurance, and inadequate training and all patients and their families. This includes: a) supportive supervision. We observed decient home visits for all index patients within 2 weeks training of staff in all categories. of treatment initiation (to enumerate all household contacts), b) symptom screening of KEY ACHIEVEMENTS all contacts (to nd concurrent patients), c) • Commitments from District TB Ofcer and sputa collection for all presumptive TB patients her team in implementing TB services. (when appropriate), and d) follow-up home • Enthusiasm of the District Collectorate in visits at the start of continuation phase making Tinsukia TB free. (repeating steps a – c). For all contacts with no evidence of active TB (using chest radiography • Existing “Models of Excellence” (Ledo PHC), when available and appropriate), TPT should which may be reciprocated in other health be offered. facilities. (Appreciation to Ledo PHC MO). 6. Operationalize the District DR-TB Center; • Chapakhowa (TB Unit Sadiya) –
102 consider outsourcing physicians services and NOTIFICATION, REPORTING AND specialists; and refurbish the DR-TB ward RECORDING (isolation unit) to make it AIC compliant by installing open windows in the exterior wall Achievements above the toilet, installing open windows • From January to October 2019, facing the atrium, installing a simple exhaust Chhattisgarh has been able to achieve 77 fan (outowing) in the wall above the toilet. percent of its notication target (public sector 7. Optimize ACF activities to high-risk 87 percent and private sector 59 percent), set neighborhoods and villages by mapping by the CTD. vulnerable populations (e.g. individual Tea • Schedule H1 surveillance contributed to Gardens, slum, coal miners), targeting mobile approximately 10 percent of case screening drives to locations with the highest notication in 2018 (2700 cases notied). expected prevalence (i.e. cases per 1000 Drug inspectors have also strongly person population), and avoiding case nding enforced the maintenance and compliance activities in low-risk, low-yield populations of H1 schedule register among the chemists which divert scarce resources from core TB in the state. elimination tasks. 8. Amplify the involvement of the general health Challenges and Opportunities system staff; include NHM. • The state has not fully operationalized the 9. Review current biomedical waste management policy of notication at diagnosis. Records policies and update these policies to ensure are entered in NIKSHAY only after practice for safe handling and disposal of treatment initiation and those with biomedical waste according to international presumptive TB or those diagnosed with TB standards (see WHOs Safe management of are not entered in the system. wastes from health‐care activities, 2017). • There is a lack of systematic data verication attempts by staff; the staff appear to be unaware of standard 3.1.2 Chhattisgarh operating procedures. As a result, there is: State Visit - Incomplete data related to most of the TB/HIV, DR-TB, and a subset of private The team visited two districts: Bilaspur and Raipur. patients; Sites visited included (among others) district TB centers, CHCs, PHCs, sub centres, prison hospital, - Data discrepancies between hard JSS hospital and AYUSH hospital. In addition, the copies (i.e. lab register, patient team interviewed various stakeholders including treatment cards) and NIKSHAY at DTC state, district policy makers, health staff, DOT Kalibadi, Tatibandh, and pharmacy; providers and patients. Below are key ndings and from the various sites visited. - Lack of linkage of records of contact screening for children and families, The state of Chhattisgarh has a population of 29.5 leading to unclear patient pathways million, with 32 percent living in tribal areas. There for decision for TPT or treatment. are 5206 sub centers, 837 primary health centers, • There is limited data analysis and use of 170 community health centers and 27 district data for program improvement and hospitals providing TB services in the state. The decision making. state has 789 DMCs, 155 functional TUs, 21 DRTB centres and four Nodal D-TB wards.
103 Recommendations health care workers. 1. All presumptive TB cases, as well as those diagnosed, need to be entered into NIKSHAY. Recommendations Consider utilizing existing NHM infrastructure 7. Engage MPWs/Mitanins (ASHA) to help at the HWC level and above to facilitate this. provide TPT to child and adult contacts. 2. Strengthen supervision and monitoring using 8. Incorporate AIC interventions in the State PIP the existing SOPs for triangulation interventions to complement existing infection incorporating NIKSHAY records in the process. control measures. 3. Undertake convergence with the general 9. Implement regular, periodic healthcare worker health system for screening and case screening as a TB surveillance tool reporting. (similar to the 2017 campaign mentioned 4. Institute regular internal program reviews as a above). routine program monitoring mechanism. 5. Data quality assurance during supervision CASE FINDING, DIAGNOSIS AND needs to be systematic. LABORATORY SERVICES 6. Build capacity of state and district staff for routine surveillance, data management and Achievements data use for decision making and program • Steady increase in private sector improvement contribution to TB case notication (4,981TB cases in 2015 to 10,855 TB cases in 2018). PREVENTION • Microscopy services have been Achievements Decentralized to all PHIs with laboratory • TPT coverage of 49 percent among PLHIV technicians. (92 percent in Raipur). • Operational feasibility of LTBI screening Challenges and Opportunities and treatment along application facilitating • Loss of TB cases along the diagnostic data recording and monitoring is being pathway: low presumptive TB case piloted in Rajnandgaon. examination rate, capacity for molecular diagnostics does not match demand (U- • Healthcare worker screening for TB DST coverage is 54 percent) and conducted in 2017 using CB-NAAT underutilization of radiology in the (23,895 screened, 1,497 presumptive TB, diagnostic algorithm. 7 TB cases diagnosed). • Suboptimal specimen transportation system (only eight percent of samples are Challenges and Opportunities received at IRL within 72 hours) and • Provision of H therapy among child substantial delays in notifying patients of contacts has improved but exact coverage results. is unknown, potentially due to gaps in • Unacceptably low yield of ACF efforts NIKSHAY data collection. suggesting a need to change approach and • No AIC interventions implemented in improve quality of these efforts. neither public or private facilities; • Existing IRL capacity not enough to meet the symptomatic cases are also not fast optimal testing demand of the State. tracked. • Administrative processes for the • Lack of regular TB surveillance among sustainability of quality IRL services are
104 unclear. In March 2020, there is a • No use of digital adherence technology for possibility of complete staff turn-over treatment monitoring. without adequate handover; this will lead to a loss of trained and skilled staff that could Recommendations result in the collapse of the State’s IRL 14. Increase private sector engagement by rapidly services. deploying the modied PPSA model to improve TB case notication, ensure quality of care, Recommendations treatment and treatment completion. 10. Design a detailed plan to improve case nding. 15. Continuously evaluate the program through Consider including a systematic screening of standardized patients and prescription vulnerable populations including children, audit(s). training and immediate implementation of 16. Employ the use of digital adherence new diagnostic algorithms, match CB-NAAT technology as appropriate. need to demand and explore the utilization of 17. For TB/HIV patients, ensure timely TB treatment digital x-rays with AI to facilitate ACF efforts. initiation and completion. 11. Implement a more robust specimen transportation mechanism with standardized DRUG-RESISTANT TB (DR-TB) processes to ensure better patient turnaround times. Achievements 12. Engage with the private sector to offer free • DR-TB Treatment has been decentralized molecular diagnostics and other DST to (OPD based) in 22 of 27 (81 percent) privately managed cases. districts. 13. Expedite the establishment of two planned IRLs. • Eligible patients are on new treatment Retain the existing skilled and trained IRL staff regimens as appropriate. to ensure the continued functioning of quality diagnostics. Challenges and Opportunities • Healthcare providers are not DRUG-SENSITIVE TB (DS-TB) knowledgeable on the proper DR-TB Achievements management practices. • The national DSTB treatment strategy • No systems of pharmacovigilance and including regimen, duration, and dosages death audits in place. were implemented (95 percent of all • No center of excellence for DR-TB. diagnosed cases are on treatment). • High treatment success rate for DS-TB Recommendations (public sector 87 percent, private sector 57 18. Employ the use of e-platforms (like ECHO) to percent - veried by phone and entered in develop capacity and improve DR-TB patient NIKSHAY). management. 19. Integrate clinical decision support mechanisms Challenges and Opportunities into NIKSHAY to assist with difcult cases. • High proportion (88 percent) of treatment 20. Integrate NIKSHAY with vital registration initiation in the private sector is based on system and pharmacovigilance only clinical diagnosis. 21. Establish a center of excellence for DR-TB • Gap in data on treatment regimens for 95 diagnosis and treatment (perhaps through percent of patients in the private sector. AIIMS hospital).
105 CO-MORBID CONDITIONS AND also provide TB services. CHILDHOOD TB • In 2016 and 2018, a systematic TB screening was done in prisons. Achievements • Food baskets provided to patients as DBT. • 82 percent of TB patients know their HIV status • PPSA light model of engaging private (59 percent among children). providers is being used. • Systematic TB screening among PLHIV • TB champions are being engaged through conducted. the TB call to action project. • All UPHCs are DMCs (45/45). Challenges and Opportunities • Underdiagnosis of TB among children; only 6 Challenges and Opportunitie percent of all TB cases are among patients • Program staff are managing the NPY under 14 years of age compared to the benets and it is a time-consuming estimate of 10-12 percent incidence rate. endeavor. • Assessment of HIV status of presumptive TB • State has not scaled up the use of ICT patients underway but needs much attention. adherence technologies such as 99DOTS. • No system in place for fast tracking Procurement of printed drug blister pack symptomatic cases for sputum testing and sleeves are pending. smear for PLHIV. In addition, turnaround • There is no reconciliation of in-kind benet times for CB-NAAT are too long. disbursal to patients NPY in NIKSHAY • Treatment success is low (65 percent) among because of an unclear process of reporting TB/HIV patients (21percent are not evaluated, and monitoring. 10 percent death rate). • Challenges in the procurement process of • Cotrimoxazole not provided to PLHIV. benets have led to substantial differences in initial and subsequent benets across Recommendations public and private sector patients. 22. Intensify case detection of pediatric TB by using • High out-of-pocket expenditures for all point of care entries (e.g. MCH, NRC, seeking TB care. Immunization). • Private sector primarily providing only 23. Update, disseminate, and implement new clinical diagnosis. pediatric TB diagnosis algorithms and • RNTCP and NUHM prepare action plans in guidelines. silos. 24. Ensure availability of preventive treatment (Co- Recommendations trimoxazole and H) for all PLHIV. 26. Re-visit the rationalization of using program 25. Enact systems that will improve the clinical staff for managing the DBT system (STS); management and follow-up of TB/HIV review ndings of the recently initiated patients. time/motion studies for different program personnel (STS) and explore alternative options MULTI-SECTORAL ENGAGEMENT, to addressing the issues. PATIENT SUPPORT SYSTEMS, 27. Ensure the procurement of necessary PARTNERSHIPS, AND URBAN TB consumables for ICT based adherence technologies by including this activity in the PIP Achievements and expediting their procurement. • RNTCP is engaged with 13 corporations to 28. Expand engagement of TB champions to address
106 the gaps in and ensure practice of patient-centric HEALTH SYSTEM care. Challenges and Opportunities 29. Expand comprehensive TB care under UHC. • For the last four years, eight positions at the 30. Expedite the roll-out of PPSA to improve TB care state TB cell and 17 positions at STDC have in the private sector. remained vacant; this compromises the 31. Work together to coordinate PIP across the capacity and ability of the state cell to State health system. effectively implement and monitor RNTCP programming. COMMUNITY ENGAGEMENT AND • High vacancy rate for many key positions at ACSM state- and district-level (90 percent Achievements specialist and 44 percent medical ofcer positions are vacant). • Strong, motivated and a well engaged system • Lack of engagement of general health of 'Mitanins'. The team met a group of 30 such system staff (e.g. MOs, RHOs, ANMs, workers (UHC-Raipur) who were Pharmacists) in the provision of TB services. knowledgeable on TB, were involved in TB household screening during their routine visits • Unequal salary compensation for RNTCP for other health programs, and provided staff as compared to other program staff treatment support to patients. with similar workloads/responsibilities. • Successful use of social media platforms (e.g. • Underreporting in PFMS with expenditure at Facebook, YouTube and twitter etc.) for raising approximately 50 percent in 2018. awareness. • Procurement delays and low supply levels • District TB forums have been formed and 54 TB at the state-level. Champions trained. • Centralized usage of NIKSHAY/NIKSHAY Aushadi at the district and TU level with a Challenges and Opportunities lack of its utilization at facility- or district- level. • Mass awareness campaign (TBHDJ) has not yet been initiated in the state; limited MID media campaign throughout the state. Recommendations • Sub-optimal functionality of TB Forums and no 36. Prioritize and expedite the lling of vacant patient literacy support is available in the state. positions at the state TB cell to improve coordination and monitoring of program Recommendations implementation. 37. Ensure a functional STDC by fast tracking 32. Expedite appointment of ACSM ofcer position recruitment of vacant positions to strengthen to facilitate state ACSM activities. training, monitoring, surveillance and training 33. Ensure that every district has at least on TB 38. Retain well-trained, experienced existing staff champion to help raise awareness and reduce at IRL to ensure its continued smooth stigma and discrimination by mentoring more functioning. TB champions. Consider incentivizing champions. 39. Provide ‘at par’ salaries for TB program staff to ensure parity and equity across all the 34. Mandate that Kayakalp project is implemented programs. in all government health facilities. 40. Increase the accountability of block medical 35. Ensure the effective use of TB Forums at all ofcers, PHC MO and RHO to ensure all levels to drive ambitious END TB vision.
107 cases complete the TB care cascade through medical colleges and other academic dedicated programs reviewed at state-, institutions for OR. district-, and block-levels. 41. Increase engagement of general health Bilaspur District system staff (e.g. MOs, pharmacists ANMs, MPWS) to improve TB case management and TEAM MEMBERS ensure successful treatment. Mr. Richard Cunliffe (District Lead), Dr. Sudarsan 42. Conduct routine review of TB program Mandal, Mr. Bruce Thomas, Ms. Marion performance at the highest district- and state- Grossmann, Dr. Pankaj D. Nimavat, Dr. Tarak levels to ensure accountability and to drive Shah, Dr. Manu E. Mathew, Dr. Kshitij Khaparde performance. 43. Train staff in and ensure use of PFMS across all BACKGROUND nancial transaction systems. Bilaspur is one of the progressive districts and it 44. Prioritize TB procurement and supply at the ranks in the rst seven districts of the state. state-level to avoid stockouts of drugs and Overall, the infrastructure of the TB program aligns other commodities. with the plans of the RNTCP with nine TUs, 57 DMCs, three GeneXpert labs and one DR-TB ward. 45. Transition to real-time electronic recording The annual case notication rate is 167 cases per from PHC level into NIKSHAY and NIKSHAY lac per year and the TSR for DS-TB cases is 87 Aushadhi. percent and for DR-TB is 54 percent. 46. Improve the infrastructure at district- and facility-level as per SOPs. ACHIEVEMENTS TECHNICAL ASSISTANCE TO END TB The district has taken a number of progressive measures for TB Control such as: AND RESEARCH AND INNOVATIONS • Mitanins (ASHA workers) are at the Achievements grassroots of the district program. The • Currently TA is provided by WHO workers are knowledgeable on proper consultants. symptom screening methods, testing and • Provision of food baskets as nutritional referral for patients from their community support for TB patients and engagement of to the nearest DMCs and health centres. Mitanins for comprehensive TB care is a • Jan Swasthya Sahyog (JSS) is an NGO best practice example for the country. providing advanced clinical support for TB care in the district. The group provides: Challenges and Opportunities patient-centric care including differentiating services provided on the • Ongoing procurement delays for drugs, basis of disease severity; follow-up (on food baskets and laboratory consumables. phone) until treatment outcome; offer • Lack of operational research (OR) agenda psychosocial support; comorbidity that is properly informed by local data and assessment and treatment; in-patient care needs. for severely diseased patients; and nutrition support for undernourished Recommendations patients. Approximately 28 percent of 47. Seek TA for procurement to ensure a consistent patients treated in a year are extra and reliable supply chain. pulmonary cases as they provide facilities 48. Develop State OR agenda and engage for testing and diagnosing extrapulmonary cases. They also conduct
108 outreach to sub-centres to provide few ways of improving case identication are: additional outreach and public health a. Ensure that no presumptive TB cases are functions. missed once they enter the healthcare • DMC is established in the prison hospital system at PHIs that are non-DMC by either and there is systematic (verbal) screening referring patients to appropriate facility or of inmates at the time of entry into the collecting for transport to nearby testing prison and by health coordinators among facility. the inmates. b. Identify areas where adding a DMC would • No shortage of drugs was observed by the improve access to patient testing and team or reported recently to the district initiate DMCs in those PHIs. Consider and sub-district level. expanding DMCs to the PHCs without a • Active engagement with many chemists in center; 16 in the district. the urban area. All were maintaining c. ACF campaigns in high-risk, vulnerable schedule H1 Registers and populations and geographic hotspots. communicating the necessary information These efforts should make use of mobile X- to the DTO through the District Drug ray van at ACF sites and prisons so that the Inspectors. Once the information is presumptive TB cases can be screened received at the DTO, then the DTC staff with a high sensitivity tool. reconcile it to remove duplicates and d. Strengthen referrals from health facilities identify which doctor is prescribing private and monitor existing capacities during care and address any systematic issues. supervision using exit interviews, referral • There is active engagement with some trends and positivity rate of referred cases. private practitioners including Apollo e. Strengthen ACSM activities (e.g. print hospital and Life Care Hospital where media, wall paintings, awareness drives, diagnosed TB patients are put on TB district TB forums, school awareness treatment provided by RNTCP and work campaigns/ competitions, etc.) with the public sector (e.g. TBHV, STS, and f. Increase engagement of private Mitanins) for patient follow-up. practitioners including traditional health care providers for TB referral services and RECOMMENDATIONS case notication by using: The State has committed to End TB by 2023, and i. Continuing medical education (CME) the Bilaspur region including the Bilaspur District opportunities, one-on-one meetings, has been prioritized for the development of a following-up on referred cases, etc. micro- strategic plan which they intend to nalize CME events should include active by end of November 2019. As the State and participation by physicians, updates District work to nalize strategic and on programmatic processes and implementation plans, the team recommended guidelines, stories of TB Champions, the following points to for consideration and adverse effects management etc. inclusion: ii. Awareness drives and creating 1. Identify all cases in the district: Suspect effective linkages between private examination rate is about 500 presumptive TB sector, traditional health care cases examined per lac per year (national providers and public systems to average is closer to 1000). Considering the promote presumptive TB case urgency for TB elimination, it should be referrals for diagnosis conrmation. ensured that all presumptive TB cases are iii. Review and further strengthen local identied and referred promptly for testing. A
109 mapping to link private providers with the time of presumptive TB by the PHI existing RNTCP workforce to ensure referring the case. Labs providing referral of presumptive TB cases, diagnostic test details need to enter results effective transport of patient samples, against the cases referred to them. This short turnaround times, availability of would allow a heightened degree of medicines for treatment initiation, surveillance as the entire TB cascade from and patient follow-up. referral for testing to treatment would be 2. Improve quality of care to completion tracked. (Treatment success is currently 87 percent e. Requests for testing from CDST labs need however, patients not evaluated is about to be initiated in NIKSHAY by the health 11 percent) facility referring the case/sample to be a. Strengthen monitoring of cases on tested. This would ensure complete treatment using treatment supporters, reason for testing, patient details etc. to be monthly home visits or health center visits, available to the lab at the time of testing and follow-up testing and DST. and it will signicantly reduce the much- duplicated effort in transcribing the b. Implement ICT based adherence process and test result in paper forms and technology such as 99DOTS and MERM so registers. that self-reporting of adherence is possible and staff can prioritize monitoring of cases f. Monitor and scale-up U-DST coverage, that interrupt treatment. aim to increase coverage from the existing 42 percent to approximately 70 percent of c. Ensure availability of TPT products (e.g. all notied cases. Pyridoxine tablets) to improve TPT coverage of under-ve contacts and PLHIV. g. Conduct refresher trainings for staff and These are available in local store supply MOs whenever lapses in program and may be procured or patients may be performance is observed. reimbursed. h. Prioritize TB Elimination specic review at 3. Strengthen training, monitoring and the highest level in the District by District supervision and HR capacity Collector. a. DTO needs to be full time for TB (currently 4. Integration of TB program with general health splitting time with other disease areas like system Leprosy, HIV, RKSK as well as a range of a. TB care should be owned by the general various administrative activities in the health system comprising the block district). medical ofcers, PHI medical ofcers and b. Recruit for 2 STS and 1 DEO positions RHOs. This ownership should increase vacancies. general health system accountability from referral to diagnosis to treatment initiation c. Fill Specialist Doctor positions (90 percent to regular follow-up until successful vacant), Medical Ofcers (26 percent treatment completion. vacant). Consider amending the State’s policy on the denition of ‘Specialist b. Role of RNTCP staff should be elevated to Doctors’ to include diploma holders with monitoring and supervision to be able to experience. ll in the gaps when identied. d. Strengthen NIKSHAY data entry. Entry into 5. Address issues in quality of services NIKSHAY currently happens only after the a. DR-TB Ward CIMS: Common ward for treatment initiation. Current guidelines both male and female patients, with a state that entry take place from the PHI at toilet under construction, and poor
110 cleanliness. AIC measures are • Decentralization of microscopy services to insufcient. The JMM team was informed all the PHIs. that COPD patients were accommodated • High treatment success rate; 90 percent for in the same ward (which potentially will newly diagnosed and 74 percent for lead to further spread of infection). previously treated cases. b. Utilization of GeneXpert/ CBNAAT site: • High TPT coverage among PLHIV (97 There are two sites (CIMS with 330+ tests percent). per month and DH with 180+ tests per • Engagement of Mitanin (ASHA workers) month). Pendency of testing at CIMS is with RNTCP at the grassroot level including 400 test samples which signies a need to involvement in symptom screening, patient coordinate and utilize both sites optimally referrals from community to the nearest to provide rapid diagnostics. DMCs or health centres and serving as a c. District drug store: Limited space leading DOT provider. to challenges in the organization of the • Decentralization of DR-TB care to district drugs and expired drugs not being level with roll out of shorter DR-TB regimen quarantined separately. There is an on outpatient department basis apparent need for more space and • Comorbidity monitoring and testing in temperature monitoring. place; 82 percent of TB patients know their HIV status, systematic TB screening among Raipur District PLHIV is being done, and 58 percent of TB TEAM MEMBERS patients are screened for diabetes. Dr. Anand Date, Dr. Senait Kebede, Dr. Manoj Jain, • A DMC has been established in the prison Mr. Ambrish Shahi, Dr. Amar Shah, Dr. Neeraj hospital and systematic (verbal) screening Agarwal, Dr. Neeta Singla, Dr. B Ramesh Babu, of inmates has been carried out at the time Ms. Sheffali Sharma, Dr. Shanta Achanta, of entry into the prison and by health Dr. Nishchit KR coordinators among the inmates. • The team observed no shortage of drugs BACKGROUND onsite or recently reported at the district or sub-district level. However, a shortage of Raipur, the capital city of Chhattisgarh has a drugs for treating MDR-TB in pediatrics as population of 28.35 lakh with a district well as cotrimoxazole preventive therapy geographical area of 2,891.98 square kilometres (CPT) for TB/HIV patients was observed. and a population density of 941.36 with an urban population of 15.33 lakh and slum population of • There is an active engagement with many 5.26 lakh. Overall, the infrastructure of the TB chemists in the urban area. All of them are program is as per RNTCP norms with 8 TB Units, 54 maintaining schedule H1 Registers and DMCs, 2 GeneXpert labs and 1 DR TB ward. In the convey the necessary details to the DTO last ve years, the district has noted an increase in through the district drug inspectors. Once presumptive TB case examination rate from 771 the information is received at the DTO, cases to 1,055 cases per lakh population and an then the DTC staff reconcile it to remove increase in notication rate from 103 to 188 per duplicates and to identify which doctor is lakh population. prescribing private care and address any systematic reason. ACHIEVEMENTS CHALLENGES AND OPPORTUNITIES The district has taken several progressive measures in TB Control: • Weak coordination between general health systems and TB service delivery. The
111 general health system (including the block Sometimes samples are transported two medical ofcers) is not involved in TB or more days after collection. program activities resulting in contractual • In 2019, the incidence of DR-TB is less than staff or lab technicians bearing most of the 2 percent of total notied cases. burden for all TB activities. NIKSHAY • Missed opportunities to diagnose DR-TB entries are also not entered at PHI-level. cases due to suboptimal LPA testing– of the • Long-term vacancies of key positions 1,811-sputum smear positive cases on including medical ofcer, DR-TB treatment, LPA was completed for only coordinator and 2 TB health visitor posts. 536 cases. • Most of the medical ofcers and staff • Only patients put on treatment are being lacked up-to-date knowledge on the entered in the notication register. This current (both technical and operational) creates a gap in information on guidelines and recent updates/changes in symptomatic persons and patients the programme. diagnosed but not on treatment. • Although TB case notication has • Turnaround time of CB-NAAT test results is improved signicantly over the past ve unacceptably high; the average years (from 104 to 189 cases notied per turnaround is from 15 to 60 days. lakh population), there has been no • NIKSHAY Aushadhi is not being used at signicant improvement in 2019 as district or sub-district levels resulting in compared to 2018. Pediatric TB cases are sub-optimal recording and reporting. also underreported (6 percent compared Stock register not being maintained for to the estimated proportion of 10 to 12 SLD, discrepancies observed between percent). drug stocks available in NIKSHAY • The supply of CB-NAAT machines Aushadhi, stock register and what is available does not meet the demand for physically available in the store. molecular testing. Out of an estimated 18,000 presumptive TB cases in 2018 RECOMMENDATIONS only around 6,000 were tested using rapid 1. Develop a budgeted operational plan at the molecular diagnostics. district level with a clearly articulated mission, • ACF campaigns have very poor yields; the vision, goals, objectives, and activity plan that strategy needs to be revisited to focus on includes specic timelines using local data to targeted areas/populations. support and achieve the END TB targets. • The TB care cascade is weak resulting in 2. Prioritize and expedite the recruitment and leakage of patients across the TB care hiring process of contractual staff vacancies continuum. Community efforts to refer (PMDT coordinator, TBHVs) as well as general cases are strong but the institutional health system staff vacancies. framework to establish referral linkages, 3. Build knowledge and capacity of DTO and receive patients/samples, run proper other staff in basic epidemiology and data diagnostics, provide test results and management to facilitate data driven decision initiate treatment in a timely fashion is making. weak. 4. Implement systematic contact tracing and • Lack of a robust sputum transportation targeted intensied ACF by mapping key and plan. Currently used vaccine carriers are vulnerable populations. being re-used and cleaned manually with 5 percent phenol; proper disinfection 5. Optimize the TB diagnostic network to meet practices are not being followed. the goals and targets of the NSP algorithms
112 including adopting the new algorithms and 3.1.3 Kerala enhancing the use of CB-NAAT, FL/SL LPA as well as radiology. State Visit 6. Ensure that no presumptive TB cases are The JMM Kerala State team consisted of 21 missed or lost to follow-up once they seek members. Apart from visiting facilities and healthcare from PHIs that are non-DMCs. patients in two separate districts (Thrissur and Either the patient needs to be referred or Wayanad), the team visited the state TB cell, samples need to be collected and transported KSACS, STDC, IRL at Thiruvananthapuram, CDST to a nearby testing facility. laboratory at Kozhikode, State Drug store, Nodal 7. Scale-up effective PPE approaches; including DR TB centers [Thiruvananthapuram & increasing access to CB-NAAT testing for the Kozhikode], Medical College STF Chairman, private sector to increase the likelihood of Corporate hospitals and had interactions with proper and accurate diagnosis and State Professional Medical Association leaders & strengthening mechanisms to ensure patient State Drugs Controller. treatment outcomes are reported. Kerala’s multi-layered sustained model of TB care 8. Increase the accountability of block medical and control is reected in the reduced incidence ofcers, PHC MO and RHO for ensuring all rate of disease which was measured at 44 cases cases complete the TB care cascade through per 100,000 people, against the national average dedicated program reviews at state-, district- of 199 cases per 100,000 people. The annual and block-level. Increase the engagement of decline rate of TB incidence in the state is three general health system staff (MOs, Pharmacist, percent, which, again, is much higher than the ANMs, MPWS) to improve TB case national average. Kerala is also equipped to offer management and successful treatment. universal DST to all the diagnosed TB cases in the 9. Ensure that samples of all DS-TB patients and private and public sector. It has achieved 69 RR-TB patients are transported to IRL for FL-LPA percent universal DST for R with CB-NAAT. and SL-LPA respectively. Additionally, ve districts offer universal DST for H 10. Ensure NIKSHAY entries for all persons with also through line probe assay. Prevalence of R presumptive TB take place at the PHI level by resistance in TB infected people in Kerala is one the general health system staff. This will percent and H resistance is less than two percent improve surveillance by tracking the care cascade from symptoms to diagnosis to Achievements treatment initiation to treatment outcome. • TB elimination mission plan: Kerala needs Utilize NIKSHAY Aushadhi for tracking TB to be congratulated as one of the few drug utilization. states in India that have committed to be 11. Engage NCD clinics to screen diabetics for “TB Free” and eliminate TB by 2025. The symptoms of TB and strengthen reporting of Government of Kerala launched the any TB coinfection cases. “Kerala TB elimination mission” aligning 12. Monitor budget head wise expenditure for with the SDGs, with objectives to achieve: optimal utilization of funds and TB Elimination by 2025; zero deaths due implementation of activities. to TB; zero catastrophic expenditure. The 13. Strengthen ACSM activities (wall paintings, TB Elimination mission document, which is awareness drives, district TB forums, school a customized version of India’s NSP for awareness campaigns/ competitions etc.) to Kerala is being released as a Government address persisting challenges with Order. discrimination and stigma. • Integration with primary health care: TB services and elimination activities are well
113 integrated into the primary health care elimination boards were formed at district system in Kerala. TB control and services levels chaired by the district collector used are the responsibility of the entire health for policy decisions and program system, at all levels, both public and monitoring. District TB Elimination Task private. Two MPHWs (Health worker- Force, Panchayat and Municipality TB Male & Health Worker- Female) are Elimination Task Forces formed at LSG available for every 5000 population and levels for LSG stewardship and eld are made accountable for RNTCP activities helped in mobilizing additional activities. support for the general health system and • Local self-government (LSG) stewardship foster multi sectoral engagement. for decentralized Planning & • Empowering community: There has been Implementation: The LSG – at district, a strong movement to involve community block and village levels – are interested, as stakeholders and empowering people engaged and committed to eliminating with knowledge and information about TB. TB. LSGs are involved in planning, • Epidemiological evidence & compilation: monitoring and implementation of TB The state has completed epidemiological elimination activities and vulnerability identication of vulnerabilities common to reduction for TB. The district panchayat or TB patients and mapping of those the LSG also provide social, housing, vulnerabilities. Epidemiological evidence nutritional, travel and rehabilitation of a declining TB notication rate despite support to patients and their families. increased cases nding efforts, declining State political leadership has called for drug sales in the private sector, right action by local government leadership. skewed age shifting further shifting to • Private sector engagement through the right, declining pediatric TB notication, system for TB elimination in private sector low prevalence of RR-TB and good (STEPS): TB Elimination in Kerala has standards of TB care in the private sector engaged private sectors for many years was documented and observed. through systematic engagement of private • Surveillance: Timely TB reporting to providers to diagnose, notify and treat TB NIKSHAY from hospital, periphery and patients. There is strong implementation private sector is happening. Drugs sales of STEPS centers at private hospitals, and data is being used for surveillance. there is support and collaboration with Schedule H1 surveillance initiated to private hospital consortiums and identify missing cases by identifying professional medical associations. These providers. act as a link between the public and • Vulnerability mapping: State has taken the private sector. They provide a single innovative step to identify and map the window for TB case notication, linkage to entire population according to the treatment support, and also ensures that vulnerabilities most responsible for TB all public health and social welfare disease. It is a signicant and outstanding schemes offered to RNTCP patients are achievement that Kerala has mapped available to patients in the private sector. 27m (81 percent) of the population for Kerala has successfully customized Project vulnerabilities. The State has clear plans JEET for establishing self-sustainable to link the vulnerabilities to ACF and STEPS centers in private hospitals for vulnerability reduction and link to patient-centered and provider-friendly TB programmatic management of latent TB care. infection once rolled out. Currently the • TB elimination board and task forces: TB state has moved into phase two and is
114 actively screening those identied Thiruvananthapuram. The State has vulnerable people to nd disease. been able to ensure a successful • Periodic contact tracing: The State transition of FIND supported staff to maintains a contact register to track and NHM ensuring uninterrupted document all contacts including those provision of diagnostic services. The under six years old every three months. State is in process of utilizing Private lab (Amrita institute) for augmenting • Airborne infection control (AIC): AIC diagnostic capacity of DR-TB. systems in place with an emphasis on the establishment of cough corners (system to - Specimen collection & screen, educate, provide masks and fast transportation: Efcient specimen track respiratory symptomatic) at transport systems are in place to hospitals, awareness raising through the transport samples from peripheral ‘handkerchief revolution’, and home AIC and private facilities to hub for CB- kits (which include 5 washable reusable NAAT; extended hours to improve clothed face mask, spittoon and access to CB-NAAT. disinfectant solution). - Intensied case nding: ACF is • Strengthening diagnostic services happening in NCD and ART clinics. • Microscopy: In the last year, 63 new DMCs • Patient centric TB services: TB services are have been enacted; 12 urban PHCs were truly patient-centered with routine and upgraded to DMCs; 58 newly upgraded systematic interventions including family health centers have DMCs. treatment support groups, holistic care of Currently 586 DMCs (Kerala has one patients and control or prevention of social DMC per 58,000 population, norm is 1 determinants using support packages that per lakh) are in place, of which 104 are in include monthly pensions, above the private hospitals. national DBT systems, and nutrition. The treatment support triad is a three-way - CB-NAAT: In the public sector, there transaction among the patient, treatment are 21 CB-NAAT machines being supporter and a representative of the used efciently at xed facilities. In health system at PHC for every 5,000 addition, two vehicles mounted CB- population and treatment support groups NAAT machines are serving in hard have helped to reduce the lost to follow-up to reach areas (in collaboration with rates including initial lost to follow-up NUHM). An additional 13 CB- rates. NAAT machines are with the private sector where arrangements have • Comorbidity management: A system for been made for running tests at periodic monitoring of ADRs and NCDs subsidized rates through the IPAQT status is in place by medical ofcers (Initiative for Promoting Affordable through fortnightly clinical review of all and Quality TB tests) scheme. persons affected with TB. Ensuring bi- Additional Lab technicians are being directional screening for TB and NCDs provided for the 14 CB-NAAT sites through NCD clinics, free insulin scheme through NGO PP scheme with Indian for TB patients, control of COPD through Medical Association. SWAAS clinics and tobacco cessation clinics. - CDST & LPA: A new laboratory facility has been developed and certied for • Local solutions: Kerala has created state- performing rst line LPA at and district-specic solutions and Government Medical College implementation models for their Kozhikode in addition to the IRL at challenges in TB control including:
115 - Unique schemes to address social of the year with high staff turnover that determinants including a non-health resulted in shut down of the lab many department scheme addressing times. This has affected patient services malnutrition among elderly. and management in terms of - Unite for Healthy Ernakulam (U4HE) unacceptable delays, universal DST and by the National Health Mission follow-up reports, and has led to drop in District Unit has successfully engaged treatment success rates of DR-TB patients. private hospitals with a • Limited capacity of X-ray, CB-NAAT, LPA: comprehensive public health The diagnostic algorithm is not always package that has shown followed to completion (CB-NAAT & X- improvements in ensuring standards rays) because of limited access to X-rays, of TB care in India, vaccination saturation status of CB-NAAT machine coverage, better reporting of and training issues. All CB-NAAT communicable diseases and averting machines are working to their maximum outbreaks. It is a low-cost private capacity. The state needs to use CB-NAAT sector engagement model and an for TB diagnosis as cases are mobilized example of good convergence of early through ICF and ACF and the programs. U4HE is also working on intention is to cut down delays. Currently capitalizing on the already existing districts where rst line LPA is carried out; resources and ensuring commitment samples of diagnosed TB patients are of medical colleges for capacity tested with rst line LPA rather than building of private hospitals. CBNAAT in order to save the capacity of - Tribal department in Wayanad is CBNAAT which is utilized to test providing nutrition, transportation presumptive TB. This has resulted in a and health support through tribal decrease in LPA capacity: only 4 of 14 promoters, including TB screening districts are undertaking rst line LPA at among malnourished preschool baseline. children. • Lack of dedicated public health experts at STDC: STDC has serious limitations in Challenges and Opportunities training capacity. Currently it is managed by three pulmonologists. As the state is • Poor infrastructure and decient HR at IRL: moving towards TB elimination, there is The team observed that the IRL is not enough HR capacity at STDC to neglected and ill-maintained. Lack of address the changing training needs adequate HR results in long delays in especially as related to epidemiology, laboratory processes and reporting public health and managerial skills. results. Due to these, LPAs cannot be Currently all epidemiological analyses offered at baseline to all patients except in and training at state and district level are four districts. Infrastructure for IRL BSL3 dependent on external TA. The statistical lab is in need of upgrades to make it a wing of STDC is redundant. center of excellence, this is a prerequisite for elimination. Lab needs better infection • Lack of documentation to properly control facilities. Currently it is fully run by evaluate cascade of care: Presumptive TB NHM contractual staff with low salaries are not referred through NIKSHAY and so and no career prospects despite the loss in cascade of care could not be performing highly skilled work and captured. working long hours. Posts for Lab • Gaps in vulnerability mapping: TB technicians remained vacant for a majority vulnerability mapping activities need
116 monitoring for validation and renement. Recommendations: The activity has also not been carried out in 1. Diagnostics/laboratory services urban areas. a. IRL • Need for integration plan at local level: i. Move the IRL to a better building to MPHW/ASHA have to make multiple visits address the gaps in infection control to households for different programs practices. leading to overburdening. ii. Invest in the IRL staff; this will ensure • Inconsistencies in documentation: Contact the provision of faster service to the tracing and documentation is inconsistent. patients and reduce the turn-around • Gaps in facility AIC: The team observed times for sample processing. gaps in formal AIC training and existing iii. Invest in permanent HR posts at IRL infrastructure. including in charge of IRL • Low uptake of TPT among PLHIV: There is a microbiologist, EQA microbiologist low uptake of TPT among PLHIV due to and senior lab technicians. ADR concerns. iv. Revisit salary structure of existing IRL • High rate of random blinded re-checking staff. (RBRC): High percentage of slides checked v. Enhance the IRL to a center of for RBRC; in some districts 60 percent of excellence; this would require slides are being rechecked by STLS. RBRC enhancements to more advanced is consuming a disproportionately high technologies to support elimination amount of STLS staff time. such as genetic sequencing to track • Delays in DBTs/other nancial benets: transmission dynamics. Persisting delays in fund release from state b. LPA/culture/DST labs: Increase LPA treasury due to natural calamity and capacity (add one additional LPA lab) and recurrent issues with PFMS observed. frequency of training at all levels to ensure • Need standardize pediatric TB diagnosis: implementation of the national diagnostic Efforts to diagnose and treat pediatric TB algorithm. are not uniform across districts. Pediatric c. Enhance CB-NAAT capabilities. CB- TB management needs to be made NAAT must be the primary diagnostic tool standardized. for presumptive TB. Advocate for • High proportion of clinical TB: Proportion optimizing CB-NAAT use in the private of extra pulmonary and clinical TB are sector. Approximately 160 additional exceptionally high (40 percent) in the state. modules are needed to cover the State for There is a need to build capacity for TB elimination. microbiological conrmation of extra d. Shortage and limited access of X-ray units: pulmonary specimens. Advocate for and procure more Need to X- • Lack of dedicated plans and policy for ray units including mobile X-ray units for migrants: No migration policy or plan to hard to reach areas (e.g. Wayanad, ensure universal access to migrants – in- Idukki). migration (e.g. guest workers from other 2. Training/capacity building and restructuring states) and out-migration (citizens of of STDC – Implement training/retraining at all Kerala in the Middle East) – and maintain levels for new approaches and focused high standards of TB care currently in activities necessary for TB elimination. For place. example, training should be conducted to strengthen managerial and epidemiology
117 skills. The State also needs more robust 8. Strengthen facility-based AIC: Provide documentation and real time monitoring of capacity building to engineers and hospital epidemiological data to go for sub-regional administrators for infrastructural certications. To accomplish this, the STDC modications and after-systems for needs to be restructured with personnel that assessment and compliance at all health have the capacity to conduct training on a facilities. Include AIC in PIP to strengthen wide range of topics like public health, facility AIC implementation and put a formal epidemiological and managerial skills. assessment system in place. 3. Increase budget allocation: In order to 9. Operations research (OR): State needs more successfully implement elimination activities, OR on TB elimination and the corresponding budget will need to ramp evaluating/validating the new approaches up as TB cases go down. Develop a costed like vulnerability mapping. ve-year plan for TB Elimination to use when 10. TPT among TB/HIV: TPT among TB/HIV advocating for more resources including patients needs attention. Document ADRs increasing central and state shares, and advocate for shorter and safer TPT mobilizing CSR grants, crowdsourcing and regimens. external grants. 11. DBT: The State needs to investigate the DBT 4. Prepare for and expand LTBI management: delays and work together with other Elimination should also include LTBI and stakeholders to address the gaps. preventive therapy. Begin building systems 12. Integration: Devise a clear plan for integration and processes to raise awareness and create at the grass root level; this will optimize demand for starting preventive therapy resource management and improve particularly to extend to vulnerable groups. efciencies. Initiatives like ‘Unite for Healthy 5. State TB Elimination Board for multisectoral Ernakulam’ could be scaled up. engagement: Translate District TB Elimination 13. Re-evaluate EQA: Re-evaluate EQA for Boards to the State level for better microscopy and implement EQA for CB- intersectoral convergence for TB elimination. NAAT. For example, LSGs, Tribal Welfare, Labor, 14. Strengthen health system to address Urban Affairs, Police, coordinating TB vulnerabilities: Focus on strengthening vulnerability reduction; Railways, ESI & other diabetes prevention and control, chronic clinical management facilities for extending respiratory diseases (SWAAS), tobacco TB services. cessation clinics and the urban health system. 6. Build capacity of LSG: Invest in training the 15. Need systematic and committed TA: In order Panchayat leaders and ofcials to respond to to build the program to the next level required the Health Minister’s request for proposals for TB elimination, there is a need for regular, around social determinants like diabetes focused TA. Medical colleges should be a control, malnutrition, smoking, COPD, source of TA and will need to step-up to full this alcohol, etc. This will improve reduction in role. The requirements for more advanced these social problems in the community and technical assistance are in analytical will help end the TB epidemic. epidemiology/big data analytics and AI. 7. E-health/applications and AI: Prioritize 16. Migrant welfare policy: State needs to develop electronic tracking of vulnerable individuals and implement a strong migrant welfare through e-health/separate applications and policy to handle in-migrants (e.g. guest linking persons to NIKSHAY from presumptive workers) and out-migrants (e.g. especially TB status. Enhance vulnerability mapping citizens migrating to Middle East countries). with AI/geo-mapping to identify hot spots to The policy should include equitable to high- add to vulnerability index.
118 quality care to all in-migrants as well as Recommendations citizens of Kerala working in the Middle East. 1. Validate the results of the vulnerability 17. Address cross-border issues: Create mapping exercise. Optimize use of mapping dialogues to address the cross-border issues by incorporating geocodes and/or AI. and increase access for care at border sharing 2. Ensure all relevant staff-level logins for districts (e.g. Kasaragod, Palakkad). NIKSHAY are being used. 18. Sub-regional certication: The State should 3. Improve documentations and records of prepare for sub-regional certication for TB supervision at all levels. elimination based on documentary evidence. PREVENTION Thrissur District Achievements TEAM MEMBERS • Strides have been made in implementing Ms. Amy Piatek, Dr. Son Nam Nguyen, Dr. Prahlad AIC initiatives in place including the use of Kumar, Dr. Salil Bhargava, Dr. Himanshu biosafety hoods in microscopy labs, and Negandhi, Dr. Rahul Srivastava, Dr. Sandeep the provision of infection control kits to Bharaswadkar, Dr. Vaibhav Shah, patients for reducing transmission of Dr. Shibu Balakrishnan infection. • There is a contact register that tracks EPIDEMIOLOGY children 119 In 2019, one-third of CB-NAAT tests were DRUG-SENSITIVE TB (DS-TB) private samples (130/403). Achievements • There is an effective specimen collection and transport mechanism to CB-NAAT • TB services are truly patient centric with a instruments in place for nearly all facilities; wide range of routine and systematic this is reducing the need for patients to interventions including: treatment support travel to the CB-NAAT themselves. groups; holistic care of patients and control or prevention of social • The district is utilizing the CB-NAAT determinants; post-TB management capacity at its maximum, including including SWAAS clinics; support extending hours to further increase packages including 1,000 rupees per capacity. month pension on top of the national DBT • There is ACF among “guest workers”; last and nutrition packages. year there were 7,073 screened in 1,252 • The team observed that there was a strong camps with ten presumptive TB identied movement to involve community as and no actual cases of TB diagnosed. stakeholders and to empower people with knowledge and information about TB. Challenges and Opportunities • Turnaround time from specimen collection Challenges and Opportunities to CB-NAAT result is not routinely • Delays in DBTs were observed. The delays measured; however, health staff noted in the release of funds from the State’s turnaround times from two to seven days. treasury due to natural calamity and • Currently, there are 39 DMCs across 94 recurrent issues with PFMS. PHIs; not every PHI without a DMC has a • TB pensions (Rs 1,000 per month) only specimen transport mechanism to a DMC. available for those TB patients below the • Diagnostic algorithms are not always poverty line. followed because of limited access to CB- NAAT and X-ray, and saturation of the Recommendations single CB-NAAT instrument in the district. 10. Create a consolidated packet of information • High percentage of slides checked for for patients and their families that includes RBRC (35 percent in the district) leading to information on treatment, compliance, side a signicant increase in workload for lab effects, infection control at home, and technicians. available support schemes (e.g. nutrition Recommendations package, DBT). 6. Prioritize the procurement of additional CB- NAAT instruments for the district; procure a DRUG-RESISTANT TB (DR-TB) 16-module instrument to replace the four- Achievements module instrument. • Thrissur has a very low number of 7. Improve access to X-ray especially for hard-to- MDR/RR-TB cases, this in part can be reach populations (e.g. tribals). attributed to the high treatment success 8. Ensure specimen collection and transport rate. from PHIs to DMCs. • The 2018 cohort of DR-TB patients had a 9. Re-evaluate EQA for smear microscopy; 75 percent treatment success rate, which is implement EQA for CB-NAAT. higher than the national rate. 120 Challenges and Opportunities Challenges and Opportunities • The team observed limited engagement of • Lack of a more robust representation from medical college for DR-TB treatment. affected communities in the elimination task force groups. Recommendations 11. Create a DR-TB committee in government Recommendations Medical College; provide inpatient facilities. 12. Ensure that there is an increase in representation from TB survivors on all TB CO-MORBID CONDITIONS AND elimination task forces. CHILDHOOD TB PARTNERSHIPS AND URBAN TB Achievements Achievements • Clear plan for scale-up and intensied ACF in NCD clinics to all institutions by • With support of the JEET ‘light’ project, November 2019. STEP centers for one-window TB services have been implemented in private • The district supports a number of patient hospitals. support schemes that supplement other schemes to specically address social • Support from, and coordination with, determinants including a non-health private hospital consortiums and department scheme which addresses professional medical associations malnutrition among the elderly. including IMA. • The team observed that there is a • Successful initiation of H1 surveillance in fortnightly clinical review of TB patients to private chemists/pharmacies; two new manage comorbidities. cases were identied through this surveillance in third quarter of 2019. • The number of pediatric TB cases has been steadily decreasing in the district. Challenges and Opportunities MULTI-SECTORAL ENGAGEMENT AND • Medical colleges are not as engaged or PATIENT SUPPORT SYSTEMS (see more used to their full potential in driving private sector participation in TB Elimination under DS-TB Treatment) activities. Achievements • The LSG at the district-, block- and village- Recommendations level are interested, engaged and 13. Draft and disseminate additional training for committed to the Kerala TB Elimination private doctors on policies and effective Mission in Thrissur. The LSG also actively collaboration strategies with RNTCP. participates in RNTCP activities and 14. Systematically increase the role of medical provides various types of support (social, colleges specically in vulnerability mapping travel, nutritional, etc.) to patients. and ACF activities and OR focused on • There is a District TB Elimination Board elimination. and a District Elimination Task Force, along with Panchayat and Municipality TB HEALTH SYSTEM Elimination Task Forces. All of these entities are multisectoral, including Achievements government and elected ofcials, citizens • The RNTCP is well integrated into and affected communities. Thrissur’s primary health care system. 121 • There is systemic use of junior health Dr. Ashwani Khanna, Dr. Yatin Dholakia, Dr inspectors and junior public health nurses. Shobini Rajan, Dr. Jamie Tonsing, Dr. Manoj Toshniwal, Dr. Almas Shamim, Dr. Ravinder Kumar, Challenges and Opportunities Dr. Himanshu Jha, Dr. Rakesh PS • Some visited public sector medical ofcers were not aware of recent RNTCP policy EPIDEMIOLOGY changes. Achievements • The district has successfully conducted Recommendations vulnerability mapping on all individuals 15. Urgently ll critical vacant posts including the using a weighted scoring system based on medical ofcer of medical college, district PPM local epidemiology. Out of all individuals coordinator and district program coordinator. mapped, 41,000 (six percent) individuals 16. Provide continuous training opportunities to were identied as highly vulnerable to medical ofcers in the public sector, especially develop TB. The district also conducts from specialty cadres, on evolving RNTCP quarterly ACF among those vulnerable policies and programs. individuals: 50 percent of new TB cases have emerged from the six percent of TECHNICAL ASSISTANCE TO END TB vulnerable individuals identied. AND RESEARCH AND INNOVATIONS • NIKSHAY entry is routinely completed by peripheral staff and private hospital nodal Achievements ofcers. Data on registers in most, but not • The district supports very useful training/TA all cases, matched with NIKSHAY entries. for NIKSHAY. • A great trainer of trainers approach with Challenges and Opportunities subsequent cascade training is being • One of the major challenges in the district is implemented at district- and sub-district- the systematic tracking of potential patients level. from vulnerable individual status to • The district greatly benets from the TA presumptive TB patient to TB positive case provided by WHO consultants. and treatment/post-treatment follow. The care cascade is also not routinely analysed. Challenges and Opportunities • Outdated registers are commonly used. • No systematic bottom-up mechanism to identify training priorities at the state- and Recommendations district-level. 1. Invest in the development of mobile- or web- • Lack of training on management, based applications that could help leadership and soft skills. systematically track all vulnerable individuals. Recommendations 2. Implement a system to ensure that paper records and NIKSHAY entries match. Consider 17. Conduct a systematic TA and training needs adding this responsibility into routine assessment to identify training priorities at supervision responsibilities until recording and district-level. reporting is completely migrated to NIKSHAY. 3. Ensure the use of the key population column in Wayanad District records particularly for tracking the existing TEAM MEMBERS tribal population in the district Mr. Wilson Lo, Dr. Christine Ho, Dr. Rupak Singla, 122 PREVENTION a system for sputum collection and transportation from PHIs to ensure minimal Achievements loss in patient care cascade. • Health facilities have a system in place for • Systematic contact tracing is periodically screening respiratory symptomatic conducted every three months with some patients; providing free masks, cough documentation. etiquette education, cough hygiene educational materials; and fast-tracking of Challenges and Opportunities presumptive TB cases in outpatient departments of health facilities by ASHAs. • The diagnostic algorithm is not always properly followed (CB-NAAT, X-rays) • AIC kits are provided with washable and because of the limited access to X-rays and reusable masks, spittoon and disinfectant saturation status of CBNAAT machines solutions to promote better patient (approximately 400 samples per month). education on cough hygiene and practice. • Specic challenges affecting tribal • A handkerchief revolution campaign for populations such as delays in diagnosis cough etiquette among school children. and lack of UDST to all tribal presumptive TB cases. Challenges and Opportunities • Very few smear negative pulmonary cases • AIC at facilities needs strengthening and seen. X-rays are not being offered to all optimization including better systems for patients. cross ventilation and air exchanges in in- patient settings especially where TB Recommendations patients are admitted. 6. Procure additional mobile vans with X-ray and • Further progressing on TB elimination will additional CB-NAAT machines to meet the require expanding LTBI services. demand. • Contact tracing documentation evidence is 7. Devise and implement a well-planned and missing for many patients. systematic ACF strategy using tribal promoters, Recommendations hamlet ASHAs, etc. 4. Train hospital administrators in properly setting up systematic AIC for in-patient settings. DRUG-SENSITIVE TB (DS-TB) 5. Prioritize LTBI management programming to Achievements further make progress on eliminating TB. • There is a system of efcient service delivery Expand the target group for LTBI management to beneciaries – all patients interviewed based on vulnerabilities already mapped and were satised with the services rendered treat LTBI with a shorter TPT. and nutrition packs received (these were received as intended except for delays in CASE FINDING, DIAGNOSIS AND DBT). LABORATORY SERVICES • All DS-TB patients are given FDCs. The Achievements drugs are issued by the drug stores and the JHI/JPHN carry it to the sub-center to which • There have been ICF efforts in NCD clinics; the patient belongs. a routine, complex four-symptom • Drugs are issued from the supply center to screening at all NCD clinics. the patients for two weeks on average with • The district has done a good job verbal instructions on tablet consumption, maintaining presumptive TB registers and 123 empty blisters are then collected. and symptoms of TB. Challenges and Opportunities Recommendations • For ARRs, some patients are travelling to 10. Devise and implement a comprehensive plan tertiary care centers. to address pediatric TB by training & retraining pediatricians. Consider including skill Recommendations development for gastric aspirates for staff nurses. 8. Invest in capacity building for ADR management and more patient education on MULTI-SECTORAL ENGAGEMENT AND where to seek care. PATIENT SUPPORT SYSTEMS DRUG-RESISTANT TB (DR-TB) Achievements Achievements • Multi-sectoral support and collaboration with aligned departments for TB • UDST is offered to most eligible cases. elimination and patient support is commendable. Tribal Department is Challenges and Opportunities providing support, including nutrition and • The team observed that old treatment cards transportation services, as tribal were still in use, there are gaps in lab promoters. The revenue department is documentation, and persisting training providing Rs 1,000 as TB pension. issues on some of the components of PMDT • Good patient support systems – Treatment especially as it pertains to patient follow- Support Groups outside the health system ups. under Local Self Government stewardship • The team observed that no aDSM forms supporting the patient needs in terms of were maintained on site. nutrition, vehicle and counselling helps to reduce lost to follow up. Recommendations 9. Implement a continuous learning and training Challenges and Opportunities curriculum for staff, printing new records • Persisting delays in DBT and TB Pension; according to guidelines. one possible explanation is that patients may not be aware of payments. CO-MORBID CONDITIONS AND Recommendations CHILDHOOD TB 11. Specically review multisectoral engagements Achievements activities in context of social benets to nd • Fortnightly clinical review for every TB ways to address gaps. patient for screening and management of co-morbidity and ADR; this is documented PARTNERSHIPS AND URBAN TB using a checklist. Achievements Challenges and Opportunities • All 35 private hospitals are part of STEPS • Pediatric TB management needs to be centers that have a trained nodal ofcer as strengthened; there is a lack of training on a single window who noties patients, gives childhood TB management and a limited RNTCP drugs, and ensures all public health number of available pediatricians. actions. There is a private hospital • UDST not offered to all children with signs consortium that provides policy support. 124 Professional doctors’ associations under Challenges and Opportunities IMA advocate to follow STCI. District health • Geographical access is a major challenge administration utilises project JEET preventing tribal people from accessing effectively and efciently. diagnostic services like X-rays and CB- • The District has no PPM coordinator from NAAT services. RNTCP who can help with the general • Improvement in capacity building of all health system and private sector cadre of staff needs considerable attention. integration. • The private pharmacy the team visited at Recommendations Vinayak Hospital maintains an H1 register. 13. Procure more mobile X-ray units and portable The team also observed the last three NAATs to be used to solve the geographical months of entries, on an average six to access issues faced by individuals particularly seven pediatric formulations were sold per tribal populations. month. 14. C o n t i n u o u s l e a r n i n g a n d t r a i n i n g opportunities for staff at all levels with inclusion COMMUNITY ENGAGEMENT AND of private sector staff. ACSM Achievements TECHNICAL ASSISTANCE TO END TB • The Kerala TB Elimination Mission is being AND RESEARCH AND INNOVATIONS implemented as a people’s movement Achievements against TB under the LSG stewardship. LSG task forces are planning, • The TA provided by WHO to TB Elimination implementing and monitoring the TB Mission through RNTCP the TSN has been Elimination Mission regularly. a valuable resource. • The ICMR has done a study on prevalence Challenges and Opportunities of TB among tribal populations as a part of multi centric study. • The IEC displays in public places were not visible. • An ICMR study on smear negative TB is being completed in the district by STDC Recommendations Kerala. 12. Increase the visibility of the TB Elimination Mission by investing and implementing a better Challenges and Opportunities communication strategy. • Best practices and results of the vulnerability mapping have yet to be HEALTH SYSTEM scientically disseminated. Achievements Recommendations • There is clear integration and ownership by the general health system. Service delivery 15. Ensure the dissemination of all best practices has been well integrated from MPHW to and evidence of success. district chief medical ofcer level. • Signicant increases in allocations and 3.1.4 Rajasthan expenditures, but the expenditure last year State Visit was still at only 71 percent. The Rajasthan State team visited two districts: Ajmer 125 and Udaipur. Below are the key ndings from the systematic engagement). various sites visited. The team also noted more specic problem areas within the State outlined below. KEY OBSERVATIONS HUMAN RESOURCES Achievements Challenges and Opportunities • The JMM team observed that the State TB team under the guidance of the DMHS was • Current stafng structure (under NHM) is very dedicated. The District TB teams were inadequate and does not match the focus also dedicated and dynamic and are great and ambition of the RNTCP’s NSP Plan. examples of highly engaged primary • Salary structure is not adequate to address health care staff. the required competencies of the • Over the past three years, TB case sanctioned positions and attract suitably notications have steadily improved– both qualied personnel. in the public and private sector. • Inadequate training, especially on the Additionally, DR-TB notications have also newer RNTCP interventions and policies improved as has treatment initiation. (e.g. UDST, PMDT, Tog, private sector) • All diagnostic tests are available, free of thereby impacting quality of cost, at the Nodal and District DR-TB implementation. centers through various state schemes. • DBT coverage is being scaled-up. Recommendations • There are examples of impressive initiatives 1. Urgently seek nancing opportunities to ll key with real impact; two examples are: the stafng gaps, and update the salary and TAD SWACH programme in tribal areas stafng structure. and use of Rajasthan free diagnostic 2. Prioritize recruitment of key positions, initiative to help and enable diagnosis of especially for the C-DST labs, district co-morbidities. accountants, TU medical ofcers, ANMs and expand use of community health workers. Challenges and Opportunities 3. Expand the training agenda and adhere to the • A large number of vacancies in key Training Calendar. This needs to be monitored positions is crippling the State’s ability to at State level. meet current demands as well as the ambitions of the NSP including diagnostic CASE FINDING, DIAGNOSIS AND capacity. LABORATORY SERVICES • Substantial gaps were observed in the monitoring and supervision of the program Challenges and Opportunities activities – both at the state- and district- • Specimen transport: Delays in specimen levels. transport contribute to high rate of culture • Underutilization of budget and other contaminations, delays in test results and bottlenecks are impacting timely payments effective treatment initiation, and create for key activities (e.g. DBT, staff salaries, travel burdens for patients. honoraria, expanded access to CB-NAAT • UDST: Only 64 percent of the eligible etc.) patients are receiving DST. CB-NAAT • Potential of the private sector is not yet fully capacity and distribution are insufcient to tapped (incomplete mapping and provide complete and timely testing. 126 • Inconsistent and untimely procurement of domestic budget (2020-21). lab consumables and reagents. 11. Request TA for output-based contracting of • Lack of a system to properly maintain and PPSA from partners through the CTD. calibrate laboratory equipment. 12. Expedite establishment of a TSU for • Biomedical Waste Management strengthening PSE and DBT. Guidelines (2018) are not implemented. 13. Recruit additional staff to cover PSE as per NSP recommendations. Recommendations 4. Identify appropriate agencies to carry out DRUG-RESISTANT TB (DR-TB) timely specimen transport from the PHC level. 5. Enhance CB-NAAT testing capacities (e.g. Challenges and Opportunities procure machines, cartridges, training etc.). • Many of the District DR-TB Centers are not Consider tapping into CSR and other sources. yet fully functional. 6. Establish a dedicated state-level procurements • Poor record keeping and lack of committee to ensure effective and efcient coordination between the nodal DR-TB procurement of special laboratory reagents centres and the feeding districts. and consumables. • Vacancy of senior MOs at the Nodal DR-TB 7. Engage agencies for AMC and calibration. Centers (ve out of seven positions are 8. Engage with the Rajasthan State Pollution vacant); incomplete training of TU MOs Control Board to ensure adherence to bio and critical lack of support and supervision safety policies, practices and norms. of primary care treatment support. • Resistance among specialist doctors in the government to use highly effective newer PARTNERSHIPS: PSE AND PPM drugs (e.g. Bedaquiline). Challenges and Opportunities • State-wide private sector facility mapping is Recommendations incomplete and potential for engaging with 14. All the District DR-TB Centers need to be made NGOs, private sector hospitals, other fully functional with DR-TB wards and proper public health institutions (e.g. prisons, ESI, AIC in place. railways, military, etc.) are not fully 15. Training and re-training to be conducted for all realized. levels of staff for optimal monitoring and • No systematic monitoring, reporting and utilization of the best available treatment and accountability for outcomes of patients safe and adequate treatment support. initiated on treatment in the private sector. 16. Ensure that all eligible DR-TB patients receive • Delayed payments to private providers the highly effective newer drugs as per national which goes against best practices of a guidelines performance-based approach. COMMUNITY ENGAGEMENT, ACSM, Recommendations AND PATIENT SUPPORT SYSTEMS 9. Map, engage and monitor all private providers Challenges and Opportunities as well as other PHIs. • Poor disease awareness and persisting 10. Expand the PIP (using the newly developed levels of stigma both within the community Partnership Guidelines) to include additional and among patients. Public-Private Support Agency (PPSA) from the • Weak to no patient education; there is 127 limited counselling and family support. Challenges and Opportunities • No clear engagement strategy for TB • DTC is located 60 kilometers from Ajmer – survivor/champion and community. leading to programmatic and • TB forums are not activated in 22 districts. administrative inefciencies. In districts that have activated the forums • In 2019, of the total TB cases notied, agendas are unclear and meeting 6,517 cases, only 25 percent received DBT. scheduling is inconsistent. Recommendations HUMAN RESOURCES 17. C r e a t e a n d i m p l e m e n t a f o c u s e d Challenges and Opportunities survivor/champion and community • Persisting vacancy of critical positions; this engagement and awareness plan with is greatly affecting program monthly monitoring taking advantage of implementation and performance. #TBHaregaDeshJeetega. Details may be found in Table 1 below. 18. Use survivor networks, TB forums and • Sr. TB lab supervisors are not provided with community meetings for awareness and motorbikes, this impacts lab quality. stigma reduction. Irregularities in TA payment further 19. Build and improve capacity of health workers exacerbates the problem. to provide comprehensive patient counselling • Many staff and treatment supervisors and support. especially the ASHA workers yet to be 20. Engage with key stakeholders to improve trained awareness and support patients’ families and communities (e.g. rotary, local media, NGO’s, COMMUNITY ENGAGEMENT, ACSM, colleges, schools) with monthly goals. AND PATIENT SUPPORT SYSTEMS Ajmer District Achievements • The district has an engaged team with a TEAM MEMBERS strong understanding of grassroots Dr. Lal Sadasivan S., Dr. Ronald Mutasa, Dr. realities, but community awareness and Thomas M Shinnick, Ms. Tanya Gupta, Mr. patient support systems remain low. Sreenivas Devarakonda, Dr. RS Gupta, Dr. Anuj Bhatnagar, Dr. Ameeta Joshi, Dr. V G Rao, Dr. Challenges and Opportunities Sarabjit Chadha, Mr. Chapal Mehra, Dr. • Low awareness and understanding of Debadutta Parija, Dr. Jyoti Jaju, Dr. Sanjay K Sinha disease in communities and patients. Limited or no patient education, KEY OBSERVATIONS counselling and family support. High level Achievements of stigma within communities. No clear local media and community engagement • Extremely dedicated district team led by a strategy. dynamic DTO under the overall guidance of the Chief Medical and Health Ofcer. Recommendations • Over the past three years, TB case 1. Create and implement a comprehensive plan notications have steadily improved – both for community engagement and education; in the public and private sector. this should include participation from all relevant stakeholders (e.g. rotary, local media, 128 NGOs, colleges, schools, etc.) with monthly 4. Procure more CB-NAAT units and ensure monitoring. This plan should also include optimization of current machines. details on the implementation of TB forums with a mechanism to monitor meetings and PARTNERSHIPS: PSE AND PPM review outcomes of the forums. Achievements 2. Introduce ICT based adherence techniques. • The district employs a dynamic PPM Engage with nursing schools to create patient Coordinator; however, he is responsible for and family education and support programs; two portfolios. this should also include capacity building for the health workers to administer said • From 2016 to 2018, notication from programs. Create a community-based private providers has increased ten-fold program that is survivor and local leader-led (from 5 percent in 2016 to 28 percent in to mitigate stigma. Develop and implement 2018). an engagement strategy with local media with the help of partners and other local agencies. Challenges and Opportunities • PSE: Approximately 60 percent of private CASE FINDING, DIAGNOSIS AND providers are mapped and registered in LABORATORY SERVICES the NIKSHAY system this should be increased to at least 90 percent in the next Achievements two years. • Highly dedicated and hard-working staff • NGO hospital (largest private provider in who are following the national diagnostic Ajmer): Despite the huge potential, St. algorithm and SOPs. Francis Hospital’s MOU with the DTO has not been renewed for two years. Timely Challenges and Opportunities payment of DP honorarium is a challenge. • UDST: Only about 50 percent of patients • Outcomes monitoring and reporting: are receiving CB-NAAT because machine There is a major gap in monitoring and capacity is insufcient to provide timely reporting on outcomes of patients testing. managed in the private sector. Only 15 • Specimen transport: Less than 40 percent percent of patients in the private sector of specimens are received within 72 hours monitored for adherence. Documentation of collection; this contributes to high rate of of treatment outcomes (i.e. treatment contamination of cultures and delays in completion, treatment success) is receipt of test results. Specimen transport completed by most private practitioners but occurs only once or twice a week. Time the quality of the data is low. from diagnosis to receipt of laboratory test • Delayed payments to providers: Payment result can be greater than two weeks for a delays range from two weeks to two test that takes two hours months; this goes against the principle and • Biosafety: Direction airow was practice of performance-based funding. inadequate or non-existent in the visited facilities which resulted in inadequate Recommendations protection for workers and AIC. 5. S t a f n g a n d r e s o u r c e s : T h e P P M Coordinator’s team needs to be expanded in Recommendations order to ensure that the performance of the 3. Streamline specimen collection for UDST. All JEET TA is scaled-up to support the district. PHIs should have a mechanism for sample PPM Coordinator also needs to be supported collection and transport. with transport (motorbike/vehicle) to improve 129 the quality and comprehensiveness of the patients in the isolation ward in the District private sector work. Hospital. 6. Improved monitoring and reporting on outcomes: DTO needs to undertake periodic Challenges and Opportunities reviews of the outcomes in the private sector in • At the DR-TB Centre, the isolation ward is addition to the reviews on notication statistics. yet to be renovated and made functional 7. Engagement with St. Francis: The district despite the availability of funds. management team needs to renew • CB-NAAT site is housed in a run-down engagement with St. Francis Hospital to tap building which has been recommended for into the huge potential of the hospital. demolition. • Coordination between the Nodal DR-TB DRUG-RESISTANT TB (DR-TB) Center and the three feeding districts is weak. The observations below were made from the team’s visits to the District DR-TB Center (Beavar) Recommendations and the Nodal DR-TB Center (Ajment). 8. Prioritize renovation to improve the Achievements functionality of the District DR-TB Center in three months’ time. • DR-TB Center: All diagnostics are available at the nodal and district DR-TB centers. 9. Consider relocating the CB-NAAT machine to a different room within the DH. • Initiation on BDQ containing regimen at nodal DR-TB center is only on an inpatient 10. Strengthen counselling services. basis (two weeks). 11. Streamline recording and reporting. • Separate space allocated for DR-TB Table 1: List of vacant positions in the district. 130 Udaipur District in the District; and innovative individual Team Members example of engagement. - Local innovation examples: Ayush Dr. Diana Weil, Dr. Ravindar Kumar, Ms. Erika doctor supervising health units and Vitek, Dr. Ashok Bhardwaj, Dr. Sameer Kumta, Dr. expanding paediatric case nding. Suman Vishvkarma, Dr. Oommen George, Dr. Additionally, DMC is using visualization Sharath Burugina Nagaraja, Ms. Priyanka Grover, of clusters of cases to guide priority Dr. Rajesh Deshmukh, Dr. Vivek Mishra efforts. KEY OBSERVATIONS Challenges and Opportunities Achievements ● Weaknesses in HR quantity, capacity and In engaging with health staff and supervision; this directly impacts quality of volunteers, the team observed results and coverage, including for commitment at all levels to deliver care, diagnosis and quality of care for MDRTB, prevention and support, and TB/HIV and paediatric patients. implementation of all basic elements of the ● Capacity of, and access to, TB diagnostics programme. requires strengthening. There are missed - Some of the impressive results are: opportunities for early diagnosis placing reported over 100 percent of district undue burden on an already over- case nding target; high treatment burdened nodal lab, on patients, and on success rate; MDRTB care increase; community workers needing to reach expanding towards UDST, examples of diagnostic services. CB-NAAT and strong contact tracing and preventive microscopy & underutilization of X-Ray) treatment for children; HIV and ● DBT access, scaleup and consistent diabetes integrated care; NIKSHAY provision is somewhat hampered by some implementation and TB among major procedures and the limited ow of indicators monitored; DBT is being information regarding expected practices rolled out; and Multisectoral for STS and patients. engagement. ● Weakness in local information use, and ● The team also noted the impressive overburdened staff due to requirements performance of some ongoing initiatives: and management of NIKSHAY. - Multisectoral collaboration through ● MDR-TB care is challenging and requires SWACH (Tribal Areas Development more training and supervision for staff at nanced NGO that offers large scale the PHC and community level. community-based TB case nding and ● Contact tracing and preventive treatment treatment support as part of their health coverage is variable; there are examples of efforts) and SATIN (Rural Development good performance in some rural, tribal Department). areas suggesting it can be improved if - Implementation of the Rajasthan Free stafng needs are addressed. Diagnostics Initiative that enables diagnosis of TB co-morbidities and TB ● Limited engagement of TB survivors and diagnostic supplies. civil society health or TB advocates. - Essential foundation for PPM: With private providers making signicant Recommendations contributions to increased case nding 1. Urgently improve HR quantity, capacity and 131 supervision via state and district NHM 3.1.5 Tamil Nadu nancing, expanded multisectoral departmental collaboration, ambitious and State Visit exible PPM partnerships/PPSA, further The Tamil Nadu State team visited state-level engagement of NGOs, and active facilities and facilities in one district: Kanyakumari involvement of more general staff and block (KK). Below are the key observations and ndings and PHC MOs. from these visits. 2. Improve access to CB-NAAT, XRay, and DST by expanding DMC capacity, sample transport, Team Members intensied case nding in medical colleges, Dr. William Wells, Mr. Nevin Wilson, Dr. Daksha mobile units, transport for DTLS, and more Shah, Dr. Ranjani Ramachandran, Dr. Shibu STLS. Vijayan, Mr. Venkatesh Roddwar, Mr. Erulappa 3. Improve clinical capacity and supervision for Thanaraj, Dr. Bhavin Vadera, Dr. Suma decentralized MDR-TB treatment follow-up Shivakumar, Dr. Subramania Raja, Dr. Anupama T and support. 4. Increase access to and consistency of DBTs Figure 1: Map of Tamil Nadu through National, State and District Source: Jose, Reeba Maria et al. “External Gamma collaboration to eliminate bottlenecks, set Dose Levels in The Soil Samples of HBRAs of Kerala standard practices and provide information and Tamil Nadu, India.” (2015) updates to patients. Address the overburdening of STS in managing this system. 5. Expand capacity and implementation of the standards of practice for contact tracing and preventive treatment. 6. Improve NIKSHAY data usability for PHC staff and STS by creating simple dashboards and greater connectivity. 7. Drive greater awareness of TB by taking advantage of TB Harega Desh Jeetega Initiative to reach the general public, patients and families, key vulnerable populations, parliamentarians etc. Consider using social media, SMS, radio and targeted initiatives or meetings. 8. To advance all of the recommendations above, use TB Forums and provide support to TB survivors/champions and other civil society to actively engage and help monitor all End TB efforts. 132 Table 1: List of key facts on the State of Tamil Nadu. Background The JMM team spent one week in Tamil Nadu visiting various health facilities and speaking to patients. Below are the names of the specic sites grouped by category. Table 2: List of public health facilities, providers, and patients visited. Type of Public FacilityNumber Name of Site Health Visited STDC 1 Chennai STC 1 Chennai DTC 1 Nagercoil, Kanyakumari UPHC Vattavilai, (KK), PHC Nattalam (KK) PHC Kollemkode (KK), PHC Munchirai (KK) PHI 6 GH Padmanabhapuram (KK) UPHC Nanganallur (Chennai West) UPHC Vattavilai, (KK), Block PHC Killiyur (KK), PHC Nattalam (KK), PHC Kollemkode (KK), Block PHC Arudesam (KK), PHC DMC 9 Munchirai (KK), GH Padmanabhapuram (KK), DTC (KK), UPHC Nanganallur (Chennai West) Block PHC, Killiyur TB Unit 2 Block PHC Arudesam DTC (KK) 2 Labs, IRL Chennai CBNAAT/ LPA Lab 5 NIRT Chennai, UPHC Nanganallur (Chennai West) CDST 1 IRL Chennai IRL 1 IRL Chennai NRL 1 NIRT, Chennai 133 Mobile Diagnostic Unit 1 Chennai ART Centre 1 KGMCH (KK) DRTB Centre 2 DRTBC (KK), NDRTBC (GHTM, Tambaram) The Voluntary health Services (Nakshatra Centre), Taramani, Sankaralingam Hospitals/ Nursing Homes 4 Hospital, Nagercoil (KK), Jayasekaran Multi Speciality Hospital, Nagercoil (KK), Immanuel Hospital, Arudesam (KK) Dr Srinivas K, Pvt Clinic, Anna Nagar, Chennai, Dr K Deepak MS-Ortho, Anna Nagar West, Chennai, Dr S Subramaniam Private Practitioners/ Clinics 5 MBBS-GP, Shenoy Nagar, Chennai, Ramachandra Hospital, Nagercoil (KK) Chandrasekar Hospital, Thuckalay (KK) Laboratory 1 DDRC-SRL, Nagercoil (KK) Vijaya Pharmacy, Ayanavaram, Chennai Rasi Medicals, Amjikari, Chennai, Apollo Chemist 6 Pharmacy, Amjikari, Chennai, Babu Medicals, Chetpet, Chennai, Bawa Medicals, Nagercoil (kk), Sanmathi Medicals, Thuckalay (KK) DS-TB: 11, H-Mono/ poly: 1, MDR: 1 Patients Visited 16 MDR with additional resistance: 0, XDR: 0, Private sector: 3 Table 3: List of stakeholder meetings the team conducted. Name of Number of Type of Representatives Stakeholder Representatives IMA 7 3 State and 4 District Chemist Association 4 4 District Drug Inspector 4 3 State and 1 District TB Champions 3 1 State and 2 District 134 EPIDEMIOLOGY, SURVEILLANCE, SUPERVISION, MONITORING AND EVALUATION Figure 2: HIV screening cascade. 101835 99593 99024 HIV screebubg 2912 93978 ACF, 964 83226 Private, 26060 Routine Screenin & 71898 Cases Notifcation Patient in Treatment Treatment Treatment Care in Initiation Outcome Success State Reported Achievements against the estimates of 90,000 (based on ● Surveillance improved with private sector drug sales). engagement, H1 Surveillance, and ACF. ● Persisting operational and managerial ● Over three years, there has been a 20 challenges for NIKSHAY implementation. percent state and 100 percent city increase ● ACF and contact investigation information in case notications largely from private is far from complete – but that does not sectors. allow zero TB case reporting. ● NIKSHAY is utilized by all RNTCP cadres ● IRL is maintaining spreadsheets for and public facilities. transmitting results to districts – no ● TB patients are notied at diagnosis (vs. reminder of when different results should treatment initiation). This has allowed the come. District to capture 60 percent of ● Double entry of data (paper and NIKSHAY) presumptive TB patients. overburdening the eld staff because users ● In Kanyakumari, there has been a 2.5-fold are focused on entering data but not increase in persons to be examined to always clear on how the system is helping detect one case; more than half of notied them to do their job. NIKSHAY is also not patients are over 55 years of age. helping PMDT reviews to present cohort data. ● State-specic prevalence survey is being ● conducted. In the sites visited, there was sub-optimal recording of DR-TB patient management. Challenges and Opportunities The Treatment Register is not available in KK and investigations were not updated. ● In 2018, the State's TB case notication ● Without guarantee of residence, sputum from the private sector was 26,000 as 135 testing may not be done. (68 percent State; 97 percent District). ● Inconsistencies and persisting issues in ● TPT is made available for PLHIV (71 data representation. percent in state; almost 100 percent in KK). - Tendency to show combined data on ● Some screening for health workers was public and private for notication, but observed. move to only public data for HIV testing, ● At Chennai, TB patients' contacts are treatment outcomes, DM testing, etc. followed-up at six-month intervals for up to - DR-TB outcomes not presented as a 1 year to screen for TB symptoms. cohort. ● Some AIC efforts are implemented: - Data presentation formats not triaging present in some OPD facilities (this standardized. is not systematic) and health facilities are - Variable ACF analysis. clean with green surrounding and ventilated out-patient areas. Recommendations 1. Analyze the percentage capture of private Challenges and Opportunities drug sales under notication to verify TB case ● IPT limited to children under six and few notication data. As a rst step towards this, PLHIV with limited impact. STO to request the drug controller to forward ● “TB Free” movement in Chennai is a low state sales data (from drug clearing and yield ACF, without no ambitious forwarding agency). prevention (TPT) targets 2. Analyze age-specic population coverage of ● Contact management is limited to screening and testing. families with no systematic coverage of 3. Capacity building of TB/HV and peripheral adults. It is not extended to the health system staff on NIKSHAY data entry. workplace or schools. 4. DTO to monitor care cascade on regular basis ● Incomplete contact investigation: only using NIKSHAY. 61 percent of index cases in KK and 45 5. Address NIKSHAY issues on: ACF zero entry, percent in Chennai South have diagnostic reminders, addition of dashboard, completed contact investigations; only and analytic tools for mobile version. 2.5 contacts per index case (vs 4.2 household size); PPSA/PPSA-lite 6. Devise and implement a plan for transition to engagement struggles to implement NIKSHAY-only and remove duplicate paper contact investigation measures. registers. ● While health worker screening is in 7. Collect iterative feedback from NIKSHAY users place in REACH and GCC, it is not in at all levels. Strengthen the design and/or place for all health workers in KK. For clarify the use case of NIKSHAY for eld-level REACH, CXR is used for the screening workers such that it can make their daily tasks and no cases have been detected so far; easier and more efcient. for the GCC verbal screening followed by CXR for the presumptive cases. PREVENTION ● Front-line staff do not have and/or use Achievements N95 masks even when treating DR-TB ● Contact investigations implemented as per patients. guidelines: TB screening for household members and TPT for children under six 136 Recommendations CASE FINDING, DIAGNOSIS AND 8. Systematically extend contact investigations LABORATORY SERVICES beyond families to workplaces, prioritizing congregate settings like hostels, boarding Achievements houses, schools etc. ● A marked increased intensity of 9. Link contact investigation efforts to more investigations (see Figures 3, 4, 5). aggressive screening algorithms, TPT policies, ● ACF campaign ramp up including 1 mega and diagnostic tools (PPD/C-TB, CXR; follow- campaign in the State and now weekly ACF up contacts every six months for 2 years) (END campaigns in KK with volunteers that are TB). supported by state funds, using village 10. Link the aggressive NCD (DM screening) health nurses. The six mobile diagnostic program to LTBI because the proportion of DM units in Chennai are helping ensure the among TB is high with one in every four TB success of these campaigns. patients presenting as diabetic in KK. ● UDST is at 79 percent for the State in the 11. Systematically introduce screening for front- public sector; this is supported by exible line health workers to provide them with nancing for sputum transport. adequate information on protection and ● In 2019, there was an expansion from 839 prevention. to 1984 DMCs in the State (per 35K 12. Consider beginning the distribution of AIC kits population). Additionally, there is at least to patients one CBNAAT facility per district (per 1M pop). One DST per 17 million population with three machines to be added. Figure 3: Graphs depicting the increase in the examination rate for presumptive TB and the trend in the TB case notifications. 137 Figure 4: Graph depicting the increase in the examination rate for presumptive T B and the trend in the positivity rate. 2019 Figure 5: Table depicting the active case finding (ACF) efforts in Tamil Nadu. 138 Challenges and Opportunities 16. Increase in RNTCP LT and STLS staff to cover ● Lack of integration of TB screening into the gaps identied in external quality NCD screenings by village health nurses assessments of the new DMCs. and health inspectors. Additionally, there 17. Focus future efforts on Xpert expansion as is a lack of use of data in family health opposed to DMC expansion. register for vulnerability mapping. 18. Expedite the procurement of 16 additional ● While much progress has been made in cartridge machines to be provided at high ACF, some challenges remain: utilization sites. - Low yield: 49 diagnosed from 90,946 screened in KK; DRUG-SENSITIVE TB (DS-TB) - Limited impact on notications; Achievements - Labor- and time-intensive efforts for all ● Medicines dispensed for ten days. Calls by eld level staff; HV and STS, Health system MOs are - Limited targeting of priority populations involved in care specially at the PHCs with a mix of multiple models; and visited. - Access to CXR is challenging (e.g., ● Private sector patients are being followed- DMCs: CXR is 10:1 in Chennai) though up by PPSA staff wherever available, most public health facilities are otherwise the majority of follow-up visits equipped with X-ray facilities. are done by HV at the district visited. ● Some of the new DMCs facilities are using ● ADR monitoring referral happening at the general lab staff with limited awareness of district level by HVs/treatment specialists smear microscopy issues; this could be a available at district. contributing factor to the low yield. ● Impressive treatment outcomes 'public' in ● Insufcient CBNAATs for case nding (vs the last ve years: DS new, 86-90 percent; UDST). 23 out of 68 CBNAAT machines previously treated, 65-75 percent; private have more than 100 percent monthly overall ,73 percent. utilization with 16 machines performing 4- 500 tests per machine per month (~5 Challenges and Opportunities cycles). ● Funds available for 99DOTS but there is a ● EQA training and supervision unit is not procurement delay. operational, this could be a contributing ● Too many data entries on multiple registers factor to the current 20 percent errors in which leaves little time for patient follow-up quality. in high burden settings ● 26 percent UDST in the private sector. ● Many LTFU due to alcoholism and migration issues. Recommendations ● Extension of treatment (4FDC) by PP for up 13. Integrate the TB program into the general to nine months. No exible guidelines as health system more holistically. per physician recommendations leading to 14. More focused ACF campaigns around management issues in the private sector. mapping of existing cases. ● No systematic death audit; checklist review 15. Implement Xpert algorithm for NCD committee not operating. population. ● Undened tools for the quality of care. 139 Recommendations Challenges and Opportunities 19. Prioritize the procurement of digital ● In KK, there is no DR-TB coordinator, sub- technology on time and validate the STAMP optimal R&R, and patient interviews pill dispenser technology. indicated missing tests. 20. Transition to exclusively online/electronic ● 259 (14 percent) patients were pre- reporting to save time for patient follow up. treatment LTFU. 21. In the context of LTFU, focus on migrants and ● The rapid change in guidelines is those suffering from alcoholism. confusing to staff. 22. Long term follow-up for up to 2 years to be ● ADR monitoring and follow-up is in place, implemented for KK under the 'TB Free KK but incomplete. ECG monitoring is limited Initiative'. to a few PHCs. Audiometry services only 23. Implement a system for TB death audits available at district level with incomplete including a designated review committee. implementation. 24. Establish a standard identication system for ● Patient transportation charges not 100 treatment supporters, with linkage to village percent covered. health nurses to address any patient treatment ● Patient out-of-pocket expenditures remain issues. (e.g. Mg, TSH). ● LTFU for short regimen in the second and DRUG-RESISTANT TB (DR-TB) third quarter of 2018 is 16 percent, H- Achievements mono converge for the rst and third quarter of 2018 is 17 percent, and death ● There are 31 District DR-TB Centers rates are 13 percent and 6 percent established. respectively. ● At the district level, there is an efcient ● No clear strategy for private providers sample transportation mechanism in transitioning to PMDT providers (sourcing place. and training providers); there is a low DR- ● Short regimen implemented since the TB awareness among PPs. second quarter of 2018 – 88 percent of ● Unclear if cohort/chart reviews are eligible patients were initiated. structured. ● H-mono is implemented with 85 percent of ● Quality of clinical care issues are not eligible patients initiated. documented. Framework exists in excel but ● BDQ-regimens available and have been not discussed as a priority dispensed to 54 percent of eligible ● Lack of patient groups and psychosocial patients. support systems. ● In 2019, 64 percent of XDR patients were ● Guidelines on follow-up schedule/daily initiated on treatment. dispensing of medicines by treatment ● All-oral regimen protocols in place with 15 supporter not in place. patients receiving this regimen. ● Most PPs refer DR-TB patients to the public ● Short regimen success rate for the second sector. Awareness on MDR-TB in PP is low. and third quarter of 2018 was 64 percent, ● Multiple data entry processes (data entry in and the H-mono coverage for the rst and three places, including google third of 2018 was 72 percent spreadsheet) that monopolize staff time. ● No hot spot mapping for MDR-TB was observed. 140 ● Contact tracing and screening tools for ● IPT coverage for PLHIV is 98 percent for KK; MDR-TB not in place. Pyridox is available; and 96 percent of ● Drug shortage issues. patients completed IPT. ● In KK, 88 percent treatment success for Recommendations TB/HIV patients. 25. Implement consistent chart reviews, including check-ins between health visitors and the DR- Challenges and Opportunities TB coordinator, to ensure all tests are ● Continued challenges in pediatric case completed and all patient complaints are nding; only three percent in the public addressed. These reviews should be driven by sector vs. 12 percent in the private sector. systematic review of the existing data on ● There is a declining pediatric trend in the completed tests. public sector but there is no evidence on 26. Prioritize the lling of key DR-TB positions whether that is a good or bad thing. within the next three months. ● Only 17 percent of TB patients know their 27. Expand private sector DR-TB coverage, DM status. including possible private DR-TB center at VHS ● No linkage to de-addiction centers. hospital in Chennai. 28. Introduce patient support groups and Recommendations psychosocial support systems including 32. Advocate for, and monitor performance on, specialized counselling (e.g. model of ve sample extraction for pediatric patients. counselors at the nodal TB centers). 33. Conduct required assessments to develop 29. Explore use of call centers to improve targets and indicators for pediatric TB. treatment adherence. 34. Establish linkages between TB programs and 30. Lab reports for CDST should have an de-addiction centers and tobacco cessation alert/message to quickly get the results. clinics. 31. Implement DR-TB guidelines for treatment of comorbidities. MULTI-SECTORAL ENGAGEMENT AND PATIENT SUPPORT SYSTEMS CO-MORBID CONDITIONS AND CHILDHOOD TB Achievements ● NIKSHAY Poshan Yojana has been rolled Achievements out throughout the State with a monthly ● Every PHC has an NCD register with pay-out of INR 90 million. bidirectional screening: 83 percent public ● State provides additional Rs. 1000 per TB patients with known DM status; and 21 month pension to eligible farmers and percent of TB patients are diabetics. agriculture laborers with TB. ● At the state-level, the public sector ● Chief Minister Insurance Scheme (CMIS) achieved: 95 percent PLHIV screened for covers tertiary care expenditure for all TB TB, 89 percent of TB patients are tested for patients. HIV; and co-location of testing (UPHC) and ● Multi-sectoral approach has started treatment (at FICTC) available (though not through a Government Order (GO) with used completely). various ministries/departments. A line ● At the state-level, 85 percent of listing of the department was prepared and presumptive patients are screened for HIV. a draft MOU has been developed. 141 Challenges and Opportunities Recommendations ● While many patient support systems are in 35. Establish a rapid response team at central place, there is limited coverage for patients level for any states or districts where the seeking private sector care. percentage of total DBT paid falls below a ● The patients interviewed by the JMM team, certain threshold (to be determined at central reported variable responses in receipt of level). payment, particularly after the initial 36. Implement a system to monitor NIKSHAY payment. Poshan Yojana in two cohorts – at notication ● High out-of-pocket expenditures for both and at treatment completion to ensure full public- and private-sector patients in payment. general and among vulnerable 37. Promote state-level exibility to use populations in particular. alternatives to DBT (outsourcing, ration ● Lack of sensitization and prioritization of shops). TB across all departments within district(s) 38. Capitalize on opportunities in other sectors. to achieve zero TB/TB free status. For example, collaborate with existing ● ICT based adherence monitoring systems schemes outside of TB (Rashtriya Kishor are not available in the district – 99DOTS, Swasthya Karyakram (RKSK) on adolescents MERM Box, Call Center etc. TB/HIV and/or work with Mahila Arogya Samiti (MAS) patients only have access to 99DOTs. on issues specic to women. ● District TB Forum is weak and needs further 39. Rectify the lack of call centers to allow patients strengthening. to express grievances. Consider studying ● Persisting issues with DBT: different methods to accomplish this goal and tailor said methods to district/state - Time-consuming to manage which can gaps/needs. lead to patient adherence measures suffering; 40. Ensure that TB Forums are functional at all levels and further strengthen existing TB - Staff becomes demotivated if they are forums by engaging TB champions in the not able to x issues locally; planning, coordination, and implementation - Low coverage of private sector patients; of TB activities; involving local groups like the - For the last two months, DBT payments SHGs, youth associations, districts level have been interrupted because of a statutory committees etc. change in district code resulting in a 41. Consider implementation of the standard nearly 80 percent rejection rate; treatment adherence medication protocol - Patients reporting missing subsequent (STAMP); maybe by rst running a pilot with payments even if rst payment was approximately 200 devices. This system made; and works as follows: patient presses button; the - Unclear guidance on prioritizing machine dispenses the correct number of pills; indicators to monitor (e.g. percentage and then sends an SMS to the with valid bank details; percentage supporter/electronic dashboard. getting at least one payment; - The cost for the machine is 1500 per percentage total due that was paid, machine, and 500 rupees every six months etc.). thereafter for the SIM 142 space in Nakshatra centers; and inexpensive adherence solutions. ● Great use of the H1 system to surveillance the sale of TB drugs. - This resulted in a 13 percent increase in private notications from pharmacies in 2018 (vs zero percent in 2017). - It has reduced the number of pharmacies selling anti-TB treatments – only 10 percent in KK. - DTO informs health visitors of all related patients in their block. ● Approximately 67 percent of the 28,776 registered allopathy facilities are mapped in NIKSHAY. Figure 6: Picture of the standard treatment ● In KK, the private sector contributed 20 adherence medication protocol (STAMP) machine. percent even without PPSA. ● Resources are identied for four PPSA PARTNERSHIPS AND URBAN TB districts (though delayed with RO). Achievements ● In Chennai, case nding has increased ● The REACH Chennai model: one PPSA can from 8,278 in 2015 to 13,680 in the rst contribute 70 percent of all private three quarters of 2019 with 90 percent of notications; ownership by the private the increase coming from the private sector health sector through provision of free and 70 percent of that from one PPSA. Table 4: A table depicting the Schedule-H1 implementation within the State. 143 Challenges and Opportunities ● Sensitization training on TB for MLAs of ● In KK, without PPSA, private sector state was held along with a signature contributions are atlined at 18-20 percent campaign. All the MLAs who attended the for four years with 74 percent having event took an oath to end TB in their unknown outcomes. respective constituencies. ● Clients and PPs vary greatly which require ● Grama Sabha' meetings were held in all adaptive models to be implemented (e.g. the Panchayats of Tamil Nadu with RNTCP prefer to retain patients vs, not; advanced staff participation in 731 of these disease and migrants vs. not, etc.). meetings. ● Only 12 percent of private facilities in the ● State working to release TB 'jingles' in both State are notifying; from REACH: 50 the audio and visual media shortly. percent of the case notications are from ● Through project Akshya, the Ayurveda & 46/900 PPs – 75 percent of the 46 are GPs. Siddha doctors are being sensitized to TB ● At the state-level, indicators, other than issues. case notications remain low: 17 percent ● TB forums are established and at least one of private patients on public FDCs; 28 meeting has been held in 30/32 revenue percent of TB patients with known HIV districts. status: 26 percent UDST. ● Even where PPSAs are in place, pre- Challenges and Opportunities treatment patient costs remain very high. ● Poor utilization of funds earmarked for ● In Chennai, there are overlapping PPSAs ACSM; through June 2019, only 15% of which leads to inefciencies. the approved funds were spent. ● The contribution of JEET lite is not ● No guidelines in place for providing apparent. RNTCP services to migrant or mobile populations. Recommendations ● Lack of TB awareness and use of services 42. Consider implementation of PPSA in KK and in particularly among the middle socio- other cities/towns with more urban economic class. populations. ● Persisting social stigma particularly in the 43. Enhance the screening of HIV patients in the lower socio-economic class. private sector. Recommendations 44. To address the issues with FDC in the private sector, consider using private pharmacies 46. Immediately use the funds available for ACSM and/or hospitals as DOT centers. to: 45. Identify and address the issues around the low a. Increase the visibility of RNTCP through UDST coverage. mass media campaigns; b. Meaningfully engage with other sectors COMMUNITY ENGAGEMENT AND (e.g. railways, State Road Transport ACSM Corporation etc.); and c. Use audio and visual media to address the Achievements wider public while also including tailored ● NIKSHAY Poshan Yojna was launched by messages to address issues specic to the Honorable Chief Minister and different socio-economic classes Honorable Health Minister of the state. 144 HEALTH SYSTEM STRENGTHENING ● Staff levels are low and inadequate. Achievements Recommendations ● Current stafng levels are sufcient for 47. Completely integrate the TB program within modest case load which allows vertical the general health system with program stafng to support public health tasks. implementation and monitoring under the However, post-diagnosis support requires DPH and clinical care management and the attention of the whole health system. supervision under DMS/DME. ● State funds are available for nancing 48. Conduct an analysis on the current HR specic district-level TB initiatives; all situation and immediately implement district funds are utilized. actionable outcomes including approval and ● TB program review is conducted by the recruitment of the correct number of staff Chief Secretary on a monthly basis. needed. ● State conducts a state common review 49. Prioritize and ll all key vacancies at the state- mission to review all health programs; TB is and district-level within three months. one of these programs. 50. Fill all posts in STDC to ensure optimal ● System in place to monitor district functionality. performance using key indicators, and 51. Reevaluate staff nancial compensation recognizing the high-performing districts. levels. Compensation commensurate with skills possessed and job security will truly Challenges and Opportunities motivate high staff performance. ● At the state level, there are many key 52. In addition to the inhouse training exercises, vacancies including: Epidemiologist, TB further build staff capacity by appointing a key HIV Coordinator, DR-TB Coordinator, ofcial to be in charge of capacity building. Microbiologist IRL, and Lab Technicians 53. Reassess the viability of key storing points (e.g. IRL. Government Medical Stores Depots, State ● At the district level, there are also so many Drug Stores and District Stores) focusing on key vacancies including: District Program storing capacity, infrastructure and Coordinators, PPM Coordinators, Senior implementation of Good Storing Practice and Treatment Supervisors and Lab Distribution practices. Also assess the Technicians, Medical Ofcers, and District transport mechanism for drugs/diagnostics by Pharmacists (total of 298 positions). transfer either inter- or intra-state with assured ● STDC is not functional. Capacity building protection of the integrity of the drugs and of key staff is largely affected. diagnostics. ● In many of the storing places visited, it was a. Address the existing gaps in the system to observed that the spaces were inadequate, monitor and maintain the temperature and ill-lit, non-ventilated without racks. humidity within the storing premises. ● Invariably all the stores (including the Including installation of air conditioners Government Medical Stores Depots) are and dehumidiers wherever not present. operated by a skeletal regular staff. Most b. Provide basic equipment to storage of the staff is under contract with low facilities like lifting forks, trolleys where the salaries; this insecurity and insufcient movement of the stores is considerably nancial compensation leads to higher; GMSDs are priority. suboptimal service delivery. c. Implement a system to properly dispose of 145 waste, expired drugs, and any other type of 60. Implement a system by which to measure expired or used inventory. In all the sites household out-of-pocket expenditure on TB visited, the JMM team observed that diagnosis and care, and develop strategies to expired drugs were not only occupying address these expenses. valuable space but were also incurring 61. Employ a system to systematically analyze TB latent additional inventory carrying costs. deaths. d. Implement a system for continued and sustained training to ensure the quality of 3.1.6 Uttar Pradesh service delivery at storing and distribution centers. The existing training programs State Visit should be reviewed, manuals should be The Uttar Pradesh State team visited two districts: updated, and modules should be Agra and Gorakhpur. Below are the key ndings developed and disseminated in a from the various sites visited. systemized periodical manner to identify and train all staff involved in PSM activities Achievements: e. Additionally, consider implementing • State TB notication has almost doubled regular inspection exercises to ensure that within two years; this is mostly associated stores have the proper security systems with an increase in notications by the installed and all safety private sector. equipment/protocols are properly • Stafng level has improved over the last implemented (e.g. re safety). three years with dedicated, committed human resources. TECHNICAL ASSISTANCE Recommendations Challenges and Opportunities 54. Develop a guideline document to address the • UDST has improved but there is still scope programmatic management of TB among for improvement. migrant populations. • Among children, TPT for children contacts 55. Set indicators for monitoring TB progress in is not being implemented and pediatric TB children. diagnosis is much less than expected. 56. Use the task list function in NIKSHAY for • ACF is happening but is lacking access to linking, tracking and following-up of contacts, accurate and rapid diagnostic tools, like especially the pediatric contacts, for TPT. digital CXR and CBNAAT. 57. Ensure the availability of the TB death report in • Gaps in the specimen collection and NIKSHAY. transportation from non-DMC PHI for 58. Consider installing a mechanism for pop-up culture testing. notications in NIKSHAY to produce alerts • Disconnect between massive amounts of when IRL results are ready. data and its use to inform local decisions. • DBT, especially for private sector patients, RESEARCH AND INNOVATIONS is less than 20 percent. Recommendations Recommendations: 59. Include a pediatric component to all research 1. Minimize/reduce turnaround time for activities, including validation of newer CBNAAT results (averaging more than one diagnostics and drugs. week currently) by either involving diagnostic 146 services from the private sector or planning for Kirankumar Rade, Prof. Rajesh Solanki, Dr. Guy more diagnostic facilities. Stallworthy, Mr. Ranjan Verma 2. Ensure contact tracing and contact investigation is being done for all index cases. BACKGROUND For TPT in children under six, State TB cell With a population of 228,800,000 people, Uttar should draft a strategy to sensitize and train TB Pradesh accounts for 17 percent of India’s health care professionals. population and 20 percent of the TB case 3. Involve pediatricians to enhance pediatric case notications. The State is comprised of 75 total notication. For involvement of Indian districts with 993 TB Units, 2063 DMCs, 38 ART Academy of Pediatrics and its local chapters, centers, 40 ICTCs, and 992 FICTCs. Additionally, Districts should come up with plans in six there are 1155 HIV testing facilities collocated with months. a DMC. 4. Strengthen mechanism for specimen collection and transportation from all health facilities. The JMM team visited the districts of Agra and 5. Consider development of revised PP MOU to Gorakhpur. Agra has a population of 4.4 million promote HIV testing in private sector SACS – people. The district is comprised of 15 blocks and within 3months. has a total of four CBNAAT machines, one Nodal 6. Ensure access to tools required for accurate DR-TB center and 1 Nodal ART center. Gorakhpur and rapid diagnosis, such as X-ray and consisted of 19 blocks with a total population of 4.8 CBNAAT during ACF. million people. The district has 21 TB Units, 48 7. Strengthen RTPMUs. DMCs, 3 CBNAAT machines, 5 LED microscopes, 8. Promote and implement capacity building for one Nodal DR-TB center, and one C/DST lab with district level staff to analyze and use data for another on the way. action. Figure 1: Map of Uttar Pradesh. 9. Ensure implementation of additional efforts to ensure proper use of DBT for all eligible patients and providers. 10. Consider a waiver to reconsider NHM budget cap of 10 percent to enable the proper TB budget for accelerated progress. TEAM MEMBERS Agra: Prof. Kenneth G Castro (District lead), Dr. Sandeep Chauhan (Coordinator), Dr. Alka Aggarwal, Ms. Annabel Baddeley, Ms. Mona Balani, Dr. Shivani Chandra, Mr. Rajan Chauhan, Dr. Bharati Kalotee, Dr. Vithal Prasad Myneedu, Mr. Collin Pierce, Dr. M M Puri Gorakhpur: Dr. Douglas Fraser Wares (District The team visited various facilities during the trip. Lead), Dr. Umesh Tripathi (Coordinator), Dr. Table 1, 2, and 3 below provide a brief summary of Dawran Faizan, Dr. Syed Imran Farooq, Dr. the facilities visited at the districts- and state-level. Avinash Kanchar, Dr. Suresh Kunhi Mohammed, Dr. Neeraj Nischal, Prof. Rajendra Prasad, Dr. 147 Table 1: A table listing all the sites visited in the Agra District. Table 1: A table listing all the sites visited in the Agra District. 148 Table 3: A table listing all the sites visited in Lucknow City. KNOWLEDGE OF THE LOCAL EPIDEMIC, Recommendations APPLICATION OF ICT AND 1. Implement schedule H1, use pharmacy PROGRAMME MONITORING surveillance data from chemists, expand PPSA and engage all providers to establish ICT Achievements enabled systems for a two-way channel • RNTCP and JEET staff trained in NIKSHAY between H1 data and NIKSHAY. to notify patients, resulting in doubling of 2. Optimize NIKSHAY server speed to cater to notications, primarily associated with current and future needs of the program. private sector engagement. Alternatively, RNTCP should consider • TB Index used for review of districts and outsourcing the service to a cloud service ranking of performance. provider – if the latter is not subject to legal barriers. Challenges and Opportunities 3. Flexible reporting output options should be • While there has been an increase in made available for customized reporting, notications by the private sector, follow- based on the users' request. up to ensure diagnostic accuracy, screening for key risk factors and UNIVERSAL HEALTH COVERAGE, comorbidities such as HIV, smoking, diabetes and alcohol use, as well as HEALTH SYSTEM FUNCTIONS, actions to ensure treatment completion INTEGRATION OF TB SERVICES WITH was not evident. GENERAL HEALTH SYSTEM AND EQUITY • Data entry in NIKSHAY is described as a IN ACCESS cumbersome and time-consuming process. Capturing presumptive cases Achievements may further burden the system. • Strong political will demonstrated at both • NIKSHAY captures a lot of information, but the District and State levels. has limited analytic output for managers at • Adequate budgetary allocation for RNTCP different levels. in NHM PIP of 2019-20, and budgetary • Limited capacity to analyze the data to allocation for state RNTCP has seen a inform program management activities. steady increase from Rs. 651 crores (2017-18) to R.s 696 crore (2018-19) to 149 Rs. 729 crores (2019-20). ACF, roll out of NIKSHAY 2) have increased • Increase in TB notications has been workload of eld staff, indirectly impacting achieved through enforcement of Act IPC quality and focus of work activities. 269/270 and through implementation of • Current STDC is unable to cater to training DBT incentives. needs of a large state like Uttar Pradesh, • Monthly DHS meetings are conducted raising concerns about quality of cascade where RNTCP is reviewed by the DM, and training (using TOT approach) at district performance is measured against the levels. District TB index. • Regional TB program Management Units • TB task-force meetings are held once a (RTPMU) dysfunctional due to frequent year. transfers and non-recruitment of • Vacancy rate is only 15 percent, meaning consultants. 85 percent of all approved state-level and • Lack of equitable access to TB care for district-level positions lled. private patients – relatively low coverage of • The STDC observed a 10-fold increase in FDC, DST and DBT. training capacity in the last ve years. • Medicine and Pediatric residents at BRD • Refresher training on PMDT, TB/HIV, Medical College are not rotated through NIKSHAY, EQA, NIKSHAY AUSHADHI, and DOTS center during training. ACF for RNTCP staff was completed this • Out-of-pocket expenses for private TB year. patients remain relatively high. • RNTCP is well integrated into the general • Funds transferred from state NHM to health system in Agra and Gorakhpur; district NHM in this scal year were program components are reviewed in delayed. First tranche received on 1 August meetings of State Health Society, District 2019 (Gorakhpur). This has impacted the Health Society, State PMDT meetings and rate of expenditure. State Task Force. Recommendations • Free diagnostic and treatment services are 4. Consider waiver of NHM 10 percent cap and available for TB patients including private increase nancial envelope for FY 2020-21 to sector patients (should the private enable the increased funds required to scale practitioners choose to offer these TB program activities to achieve the ambitious services). TB elimination goal by 2025. • DBT payments have been initiated for 5. Add state level training units (focused on patients and providers. In 2019, 64 training and monitoring) STDC to monitor percent of all eligible beneciaries in the quality of cascade training in districts. public sector and ve percent in the private 6. Reduce workload of eld staff like STS by sector. outsourcing non-core activities such as DBT. 7. Increase workforce and WHO consultants to Challenges and Opportunities improve monitoring and TA. • NHM cap of 10 percent for additional 8. Improve functioning of RTPMUs by direct budget allocations (as compared to prior recruitment of positions by GoUP and by FY budget allocation) threatens to limit TB further clarifying the roles and responsibility program scale-up plans. of the RTPMU. • New initiatives (e.g. DBT, Universal DST, 9. Add state level training units (focused on 150 training and monitoring) STDC to monitor screening of HCWs. quality of cascade training in districts. • Gaps in TB infection control: administrative 10. Rotate and train Pediatric and Medicine procedures not in place; no fast tracking of residents through RNTCP facilities. patients with cough in waiting areas of 11. Ensure that private sector TB patients have health facilities; personal protection access to all TB services that are available to equipment (PPE) not used consistently in public sector patients. hospitals or CHCs and PHI. 12. Give TB patients priority in receipt of available social protection schemes. Recommendations 13. Resolve the impediments in funds transfer from 14. Ensure linkages between TB ACF at state NHM. facility/community level with TB preventive treatment. Systematic contact investigations PREVENTION will help ACF yield. 15. Enforce systematic initiation of TPT among Achievements child household contacts once TB disease is • Coverage of TPT in child contacts increased ruled out. from 1,626 (two percent) in 2018 to 16. Ensure 100 percent coverage of TPT among 39,870 (50 percent of contacts identied) eligible PLHIV. during the rst nine months of 2019 (public 17. Strengthen recording and reporting of contact sector). investigation and TPT among child household • AIC measures are implemented fairly well contacts and for TPT among PLHIV. at high-risk care centres (Gorakhpur), but 18. Expand RNTCP/JEET activities to support relatively limited in other settings (Agra). public functions for TB patients notied from private sector Challenges and Opportunities 19. Increase efforts for TB case nding at facility/in • Household contact investigations are not community to also include provision of TPT implemented systematically, with contact 20. Expand the role of RNTCP/JEET partners to investigations conducted in less than a third cover public health functions of contact of the TB index patients. investigations and provision of TPT for private • No contact investigation conducted for TB TB patients (e.g. contact investigation and patients in the private providers. preventive treatment). • TPT in children was not implemented 21. P u t i n p l a c e m e a s u r e s t o e n f o r c e among 50 percent of those child contacts implementation of the hierarchy of infection identied. control precautions, including personal • NIKSHAY issues: data missing on protective equipment for HCWs involved in household contacts (and on treatment patient care. cards) and of TPT among children under six 22. Enforce periodic CXR screening of HCWs. and among weaknesses in reporting on TPT people living with HIV. • TB reported in healthcare workers (HCWs) CASE FINDING, DIAGNOSTICS AND – three doctors with MDR-TB, two staff LABORATORY SERVICES nurses, and two other doctors with DS-TB in Achievements 2018 and 2019. • Between 2017 and 2019, there has been a • No systematic policy for regular TB doubling of notications in Uttar Pradesh, 151 and a tripling of case notications in Agra. population – increase number of machines, • Having piloted the use of the public postal contract services of private laboratories, etc. service for sample transportation, plans for 25. S t r e n g t h e n c a p a c i t y t o p r o c e s s formal engagement and statewide scale- extrapulmonary clinical samples, as per up are in motion. RNTCP policy. • Molecular diagnostics are being scaled- 26. Scale -up ACF activities in targeted up, although primarily for UDST with up to populations at both the district- and state-level 45 percent of DST conducted in sites based on epi evidence, and ensure access to visited. tools required for accurate diagnosis, such as • Efforts have been made to conduct ACF, CXR and CBNAAT machines. including 56 million population mapped 27. Strengthen capacity to ensure implementation in 2019 resulting in 14,000 TB patients and uptake of new RNTCP diagnostic notied and hotspots identied in Agra. algorithms in both the public and private • Staff is well trained and updated with the sector. current guidelines. 28. Systematically engage private practitioners in rural areas, including AYUSH providers, to Challenges and Opportunities ensure that all TB patients are notied, and • Specimen collection and transportation maintain notication registers at all PHIs to from non-DMC PHIs is lacking in both facilitate monitoring. districts. 29. Maintain notication registers at all PHIs to • The standard one DMC per 100,000 facilitate monitoring. people is not yet available (currently there are 2021 DMCs for 230 million DRUG SENSITIVE TB (DS-TB) population). Achievements • In Agra and Gorakhpur there are only 4 and 3 CBNAAT machines respectively. • Reported TSR among notied TB patients is high in sites in the districts visited (89-90 • ACF is happening but on a small scale, but percent); the State success rate overall was the necessary tools like CXR and CBNAATs 70 percent in 2018. are not available. • Adequate supply of rst line anti-TB drugs is • A high proportion of clinically-diagnosed available with no reported stock-outs in the TB notications among privately notied sites visited. patients (88 percent in Agra). • Good treatment support and monitoring • Private engagement in rural areas is was noted among TB patients notied by lacking with no involvement of AYUSH the public sector (8/8 in Agra). practitioners. Recommendations Challenges and Opportunities 23. Strengthen and monitor mechanisms for • Large proportion of “clinically diagnosed” specimen collection and transportation from TB patients was noted in the private sector, all health facilities and monitor the associated with high treatment completion engagement of the public postal service in rates (90 percent in Gorakhpur) that were sample transportation. based on verbal reports and limited 24. Increase CBNAAT coverage and diagnostic monitoring or follow-up (3/3 in Agra). capacity in districts to meet the norms per Time from diagnosis to treatment initiation 152 was long in some patients, and as long as treatment in Uttar Pradesh in the rst three two weeks in certain cases. quarters of 2019. • TB patients coming to private clinics for • IRL (STDC) and JALMA Culture/DST in Agra their diagnosis are registered as TB on and IRL at King George's Medical University treatment under NIKSHAY, based on the (KGMU) in Lucknow, are fully functional OPD slip without actual verication from and supporting 33 (8, 6, and 19 the JEET staff. respectively) Districts; across the state there • Digital adherence mechanisms such as are: one NRL, two IRLs, and six C/DST 99DOTS are available to TB patients living laboratories with ve additional new with HIV but not to other TB patients. laboratories planned. • Molecular diagnostics are being Recommendations implemented – UDST started (45 percent 30. RNTCP to increase capacity to ensure proper combined with 65 to 70 percent in the follow-up of all notied TB patients, public sector, but only 20 percent in the irrespective of whether they are notied from private sector). the public or private sector. • A courier system for specimen transport to 31. RNTCP to monitor and ensure timely initiation IRL Varanasi has been established and is of treatment after diagnosis. functional in Gorakhpur. The use of government postal services (NB issue of 32. Implement and monitor criteria for acceptable special stamp) has also been “clinically diagnosed” and “treatment implemented. completion” standards. • District health system is responsive to drug 33. JEET staff to ensure visits and verication for shortages for DR-TB patients by using local each TB patient being registered under procurement as necessary. NIKSHAY; district PPM team should ensure proper monitoring and take regular feedbacks from JEET and other partners that Challenges and Opportunities are covering the private sector in the area of • Insufcient CBNAAT capacity in both Agra operation. and Gorakhpur, and KGMU for UDST. 34. Ensure all treatment cards are complete. • Culture laboratory at BRD Medical 35. Scale-up appropriate available digital College, Gorakhpur, almost ready to start technologies (e.g. 99DOTS) as an aid to providing services, but lacks adequate support and monitor patient treatment staff. Additionally, renovation, equipment, adherence. and staff for line probe assay laboratory at BRD Medical College, Gorakhpur, are also needed. DRUG RESISTANT TB (DR-TB) • There have been HR shortages of Achievements designated staff at the nodal DR-TB center and DR-TB ward in KGMU in Lucknow but • In both Agra and Gorakhpur, MDT has stafng levels have been maintained by been implemented, scaled-up and is being improvisation and relocation of staff. decentralized with use of recommended regimens (H resistant-TB, Conventional • District DR-TB centers under nodal DR-TB MDR-TB, Shorter Treatment Regimen (STR), center at KGMU are not fully functioning BDQ-containing and XDR-TB); almost (established in 2018). 11,000 RR-/MDR-TB patients initiated on • SLD storage and management at 153 Gorakhpur DTC drug store is relatively 40. Increase staff capacity to ensure RNTCP limited space-wise and overall suboptimal. guidance on admission of DR-TB patients is Likewise, drug supply management at SDS properly implemented. Agra is also suboptimal. 41. Increase LPA capacity, with timely sample • Slow uptake of the new BDQ-containing collection, transportation, and result delivery regimens. ensured. • In Agra, patients eligible for the STR are 42. Activate LIMS and link it to the RNTCP system; being admitted for up to a week in district LPA results should be sent to nodal DR-TB DR-TB centers for treatment initiation. center in addition to the relevant District. • Few patients (approximately 20 percent) 43. Ensure accessibility of NIKSHAY systems for the have samples for SL-LPA collected, with nodal DR-TB center. turnaround times for these results ranging 44. Ensure that drug stores are adhering to proper from 2 weeks to more than a month at best storage and management guidelines of SLDs. (in Agra, Gorakhpur, and Lucknow); LPA 45. Immediately ensure the availability of DLM for results are not being sent to nodal DRTB the treatment of pediatric (children under 6 center doctors (in Gorakhpur and years of age) DR-TB cases. Lucknow). 46. Ensure AIC measures are implemented • The nodal DR-TB center has no access to completely in all health facilities, especially in the districts' NIKSHAY system (unless high-risk settings. provided with District password), because of this the nodal center has no information PEDIATRIC TB on DR-TB patients in the districts. • Suboptimal storage and management of Achievements SLDs at drug stores; this was observed both • Pediatric dispersible FDCs are mostly at the Gorakhpur DTC and Agra SDS. available. • No DLM is available for pediatric (children under 6 years of age) DR-TB cases Challenges and Opportunities (Gorakhpur, Agra, and Lucknow). • Six percent of notied TB patients are pediatric cases, indicating under-notied Recommendations cases. 36. Increase CBNAAT capacity as soon as possible • In quarter three in Agra, 80 percent of the and consider engagement of private labs at 459 pediatric notications were notied by both the district- and state-level. the private sector. 37. Implement urgent measures to recruit staff to • A third of the 143 private pediatricians in ensure functionality of the C/DST lab at DRB Agra are not yet registered in NIKSHAY. Medical College functional and the LPA • No mechanism to track notication of laboratory. children diagnosed by pediatricians. 38. Monitor uptake of BDQ-containing regimens • Limited ability to perform gastric lavage for all eligible DR-TB patients at the nodal DR- within medical colleges. TB and state level. Consider having RTPMUs • Inconsistent understanding of the latest monitor drug stock management and supply RNTCP guidelines regarding diagnosis, to ensure drug availability. child TB prevention, and treatment. 39. Complete decentralization as per RNTCP • Lack of patient education on the policy to district DR-TB centers under the nodal importance and duration of treatment. DR-TB center, KGMU. 154 • H dose for children living with HIV is not • Diabetes, tobacco, and alcohol use available in Agra ART center, and staff are documented on TB cards reviewed and in unaware of the current relevant policies. NIKSHAY. • Inconsistent adoption policy/screening • Diabetes testing (in the public sector) among malnourished children under increased, from 10 percent in 2017 to 46 Nutritional Rehabilitation Centre – (not percent in 2019; known tobacco use status implemented in Agra District Hospital also increased, from 19 percent in 2017 to Nutrition Rehabilitation Centre). 46 percent in 2019. Recommendations Challenges and Opportunities 47. Implement the collection of accurate data on • Late presentation of people with advanced childhood TB and updated burden estimates. HIV disease – reported average of CD4 48. Strengthen the engagement with Indian count is 150 cells/cubic milliliters at Association of Pediatricians and Nutrition enrollment in Lucknow ART center. Rehabilitation Centers. • No access to urine LAM testing for TB 49. Establish mechanisms to track the child TB diagnosis in people with advanced HIV cases detected at medical colleges. disease. 50. Consider using the ECHO platform for • As a low HIV prevalence state there is capacity building of doctors in diagnosis and limited access to ART services – one ART treatment of pediatric TB. center available for three districts (Agra, Firuzabad and Mathura), necessitating TB/HIV AND OTHER COMORBIDITIES patients to return once a month to the ART centre for TB treatment and ARTs. Achievements • Limited capacity to conduct joint supportive • There is an overall upward trend in TB/HIV supervision. activities, and great collaborative action on • Symptom screening is not standard (as per TB, diabetes, and smoking. four symptom screen) across all ICTCs and • The majority of DMCs are co-located on ART centers; this was deduced from patient the same campus with HIV testing facility, interviews and ICTC interviews in Agra. and CBNAAT co-located on the same • Access to rifabutin and cotrimoxazole, and campuses as most ART centers. H for children living with HIV not available • Monthly HIV-TB coordination meetings are in all facilities in both Agra and Lucknow. being held regularly. • Rates of co-management of TB and • High-coverage of HIV testing among TB diabetes in the public sector is only at 37 patients notied in the public sector in percent. 2019: 92 percent in Gorakhpur, 95 • Reconciliation of data on TB and diabetes percent in Agra, and 85 percent in the needs to be completed. State. • Low coverage of HIV testing (27 percent), • Intensied TB case-nding implemented ART (11 percent) and CPT (three percent) and recorded in ART sites and ICTCs, and among patients notied in the private well-maintained line-lists to reconcile HIV sector. status of TB patients. • Limited uptake/reporting of screening or • 99 DOTS implemented for PLHIV on TB co-management of comorbidities in the treatment. private sector. 155 • NACO partnership guidelines and MOUs MULTI-SECTORAL ENGAGEMENT & reportedly not conducive for HIV testing by PATIENT SUPPORT SYSTEMS individual private practitioners or laboratories. Achievements • There are paper-based and digital • Children with TB are being “adopted” as recording systems for both TB and HIV part of a campaign sponsored by the UP which has resulted in increased Governor to encourage ofcials and administrative burden for all health care departments across the state departments workers, and comorbidities such as DM, to promote diagnosis, supportive services, smoking, and alcohol being recorded only and completion of therapy. on HIV cards but not on TB treatment cards • Social mobilization network (SMNet) for of the same individual or in NIKSHAY. immunization is being utilized for ACF • No reconciliation of ART data at the district- campaigns. or state-level, and no linkage of data • Implementation of JEET project has systems. In NIKSHAY, ART coverage is 36 increased the reach of DBT, and free percent and cotrimoxazole is 24 percent in diagnostic and treatment services. 2019 in public services in Uttar Pradesh, • NIKSHAY Poshan Yojana, DBT extended to but NACO data suggests coverage rates of 57 percent of patients in public and 81 up to 90 percent. percent in the private sector. • X-rays for all presumptive and on treatment Recommendations TB patients are provided free of cost. 51. Facilitate further decentralization of ART services by RNTCP and NACP so that there is at Challenges and Opportunities least one ART centre per district and through select CHCs. • There is a lack of systematic planning for multi-sectoral engagement. 52. Strengthen joint supportive supervision and mentoring. • There is outreach to various departments but no umbrella body. 53. Strengthen capacity for TB screening and disseminate posters with the four symptoms • Intradepartmental convergence to extend more widely. available services to TB patients. 54. Strengthen capacity and put in place measures • Services heavily dependent on RNTCP to ensure scale-up, recording, and reporting resources at the level of healthcare; of the full cascade of screening and co- additionally, JEET services have not yet management of HIV and prioritized expanded as planned. comorbidities for TB patients notied in both • TB service delivery in public sector facilities the public and private sector. like railways, CGHS, ESI, police, defense, 55. Revise partnership guidelines so that RNTCP etc. – partnership activities restricted to the can better work with the NACP. and enlist private health sector. private labs to conduct HIV testing as partners • Lack of health sector integration - CXR for of NACO/SACS. all presumptive and on treatment TB 56. Ensure availability of rifabutin, CPT, and H for patients being provided free of cost, but not children living with HIV. this is not enough. Knowledge gaps were evident in health sector integration during 57. Strengthen recording and reporting, and eld visits. ensure reconciliation of reporting across TB and each comorbidity by creating linkages across reporting systems. 156 Recommendations citizens, TB patients, public sector 58. Convene meetings at the state-level with providers, and private sector providers. appropriate state leadership to promote and • The call center has connected to around encourage multisectoral convergence under 150,000 patients. TB Haarega Desh Jeetega campaign. • Inbound calls were mostly focused on 59. Mandate District TB Forum so that they can information, grievances, case notications further spread the messaging, monitor especially from private doctors, and patient implementation of activities, and act as information updates from public sector accountability mechanisms. providers. There are approximately 30 to 60. Organize a joint meeting between the District 40,000 calls per month (48 percent from TB Forum and District Health Society on a (at general citizens and 46 percent from TB least) bi-annual basis. patients). 61. Expand widespread dissemination of • Outbound calls mostly focus on core roles framework. related to DBT (often to get bank details) and counselling. More than a million calls 62. Extend the use of TB tests and pre-treatment connected (42 percent to Uttar Pradesh). evaluations under the free diagnostics scheme to address reportedly high out-of-pocket Challenges and Opportunities expenditure. • Only eight of the total 58 functions are 63. Scale-up the IDAT initiative by prioritizing high covered currently; unclear if these functions burden urban areas and including the private are prioritized. sector. • There is limited dissemination of the toll- 64. Explore the ability for additional benets free number in all states, hence limited through the PRI/PDS system for nutritional uptake. support (including in-kind support). • Currently, hoax incoming calls and 65. Extend clinical care at subdistrict-level to TB unanswered outgoing calls account for 50 and Dr-TB patients at CHC and sub district percent of all calls; there is a need to hospitals free of cost to mitigate and avoid analyze the call data to nd ways to reduce observed catastrophic costs incurred. the number of unproductive calls. 66. Implement enablers and support systems for • Random and erratic deployment of call patients, families, and providers with support center staff is currently focused largely on from the Government, NGOs, and other coordination of DBT for NIKSHAY Poshan sectors; consider implementing support (e.g. Yojana. through nancial, DBT, vocational, nutritional, counselling supports, etc.), and assess ways to • Non-systematic use of call center for limit, and eventually, avoid out-of-pocket outbound calls for treatment counselling, expenses incurred by patients and their which was mainly in form of monologue families. and reading out a memorized script with unclear impact. Agents do not take any additional notes or actions if any critical PATIENT SUPPORT SYSTEMS - CALL gaps in information are detected CENTRE, NOIDA Achievements Recommendations • In May 2018, a toll-free number with four 67. Disseminate information about the availability target audiences was established: general of call centre through TB Champions, patient 157 networks and community groups management or reporting of prioritized 68. Prioritize functions of the call centre to focus comorbidities. from amongst current 58 functions, based on • Relatively few high-volume specialists and both program need and professional hospitals are engaged: 75 percent of PPSA judgement that these are functions that lend notications from just 364 providers (24 themselves to call centre intervention per district average 4.2m population). a. Then the agents should be deployed based • Partnerships are externally funded and on a rational and intentional plan, rather centrally managed because there is no than ad hoc and at random as at present State or District budget. b. Then their effectiveness and cost- • Only four out of 23 urban PHCs in effectiveness should be assessed Gorakhpur and ve out of 40 in Agra offer continuously, with continuous adjustments TB diagnosis. in the light of data and experience 69. Install professional management via the hiring Recommendations of the two consultants to support the call 70. Budget for PPSAs in PIP and contract strong centres (in Navi Mumbai and Noida) as soon implementers per the new Partnership as possible. Guidelines. 71. Extend programme services to privately- PARTNERSHIPS AND URBAN TB notied patients. Achievements a. Aim for more than 70 percent coverage of DBT for both private patients and • Notications from the private sector more providers, 70 percent coverage for DST, than doubled. and 50 percent coverage for FDC. • CHRI/Lepra, IMA, WHP and REACH are all 72. Increase engagement of the private primary active. care sector to increase coverage and support • JEET PPSA districts are performing better patients earlier by: overall. a. Working with pharmacists' and druggists' • Urban PHC staff are sensitized to TB. associations to enforce Schedule H1, use data to contact and support private Challenges and Opportunities patients, and dispense FDCs (with • Quality indicators for private sector appropriate incentives). notications are poor even in the PPSA b. Engage more GPs, and informal providers, districts. in the 10 to 100 cases per year range. • Treatment success rate in private sector TB c. Make maximum use of the call center to patients is of questionable validity. support private sector notications and Particularly the private sector is under treatment adherence. performing on the following indicators: 73. Ensure eld staff provide public health actions • FDC coverage is only three percent; for all patients. • NPY DBT coverage is only eight percent (vs. 74. Improve the utility of NIKSHAY for monitoring 57 percent for public sector patients); private provider engagement by tracking • PP DBT is only 14 percent; payment of PP incentives, improving tracking of FDC and the standards for reporting private • DST is 17 percent; and outcomes. • Very limited screening coverage and co- 158 COMMUNITY ENGAGEMENT AND (one third of the previous year's budget) ACSM both at the district- and state-level; this poses a risk to continued, efcient ACSM Achievements and community engagement activities. In • There is intensive community engagement the last FY and the rst three quarters of including with students from university and 2019, only 40 to 50 percent of the activities colleges, especially during ACF planned (and unplanned) could be campaigns. Last four rounds suggest it completed. Wide variation across districts has contributed to creating more with minimal activities driven by budgetary awareness and increasing outreach. constraints. • The mentorship program implemented by REACH has helped create a pool of TB Recommendations champions (23 across 12 districts in Uttar 75. Implement and use TB Forums to raise Pradesh) who have conducted community awareness on the social protection programs. engagement activities on their own and in collaboration with TUs in their area. 76. Build awareness about TB Forums and their REACH further linked them with NGO role in the community particularly among networks to help expand coverage. people affected with TB to help address eld level issues and challenges. • TB forum is operational with membership as per guidelines at the state and in all 77. Ensure that there are adequate budgetary districts. Seven of 75 districts are yet to provisions for community engagement and have the rst meeting and about a third of ACSM activities, including at the TU level. districts have had their second or third 78. Prepare compendium of social protection meetings. programs at the district- and state-levels along with details on eligibility and how to access Challenges and Opportunities benets; this should be shared with all TUs, • While there is a plan for ACSM and STS, and STLS during community engagement community engagement at district level, activities. there are no such plans at the TU level. Hence many of the community TECHNICAL ASSISTANCE engagement activities are ad hoc. There are also limited plans for advocacy Recommendations activities. 79. Procure help from the RNTCP Technical • ACSM and community engagement is not Support Unit at the state-level as planned. providing information on social protection 80. Increase RNTCP consultants and/or other programs to reduce the vulnerability of TB trained workers until 2026. patients. 81. Rotate and train pediatric and medicine • STC and DTC have no information on residents through RNTCP facilities at the state- gender-framework for TB and its level. implementation. 82. Use ECHO for pediatricians to provide support • All IEC materials at the district- and state- to the CHC level for the management of level are in Hindi, but not in the regional pediatric TB patients and consider use for languages (e.g. Bhojpuri, Bundelkhandi) wider support. common to the rural areas. 83. Train and hire TB champions and survivors to • There was a reduction in the ACSM budget provide technical support to TB forums. 159 RESEARCH centres at the state level and within different departments of medical colleges. Recommendations • Assess and identify factors associated with 84. Create awareness and demand for the use of long turnaround time for DR-TB testing. existing research resources at the state-level. • Study factors for the delay in treatment 85. Increase awareness of RNTCP supported initiation after conrmed diagnosis. operational research among medical college • Identify factors (and SOPs) for increasing faculties and PG residents and encourage the uptake of DST in the private sector. uptake of TB related thesis/dissertations and funding. • Enumerate barriers to, and enhance implementation of, contact tracing. Suggested areas for research • Assess safety and efcacy of STR for RR- • Assessment to identify criteria for “clinically and MDR-TB patients (amended BEAT study diagnosed” amongst adult patients, using BPaL). especially in private sector patients. • Introduce mortality audit of TB patients to • Assessment of the application of the assess factors leading to treatment failure denitions for 'clinically diagnosed' and and/or death, and identify areas for 'treatment completion' in the private sector. improvement at the national level. • Conduct surveillance of TB and MDR-TB among health care workers of DR-TB 160 3.2 List of Participants 3.2.1 Thematic Groups Overarching and guiding the thematic groups: Theme 1. Epidemiology, Surveillance, Supervision, Monitoring & Evaluation 161 Theme 2. Preventive Services Theme 3. Case Finding, Diagnostics & Laboratory Services 162 Theme 4. Treatment Services for Drug Sensitive TB (DS-TB) Theme 5. Drug Resistant TB (PMDT) 163 Theme 6. Comorbidities and Childhood TB Theme 7. Multi Sectoral Engagement & Patient Support Systems 164 Theme 8. Partnerships, PPE and Urban TB Dy. Addl. Director General-TB Theme 9. Community Engagement, Advocacy, Communication, Social Mobilization Talukdar 165 Theme 10. Health System Strengthening Theme 11. Technical Assistance to End TB in India 166 Theme 12. Research and Innovation 167 3.2.2 Field Visit Teams Assam State State Lead: Dr. Patrick Moonan Team: Tinsukia (12 members) Team: Kamrup Metro (12 members) 168 Chhattisgarh State State Lead: Dr Richard Cunliffe Team: Raipur (11 members) 169 Team: Bilaspur (8 members) Kerala State State Lead: Dr Amy Piatek Team: Wayanad (12 members) 170 Team: Thrissur (9 members) Rajasthan State State Lead: Dr Diana Weil Team: Ajmer (14 members) 171 Team: Udaipur (11 members) Uttar Pradesh State State Lead: Dr Kenneth G Castro Team: Agra (11 members) 172 Team: Gorakhpur (12 members) Tamil Nadu State: State Lead: Dr William Wells Team: Kanyakumari (10 members) 173