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Document of The World Bank Public Disclosure Authorized Report No. 15894-IN STAFF APPRAISAL REPORT INDIA Public Disclosure Authorized PROPOSED TUBERCULOSIS CONTROL PROJECT January 6, 1997 Public Disclosure Authorized Public Disclosure Authorized South Asia Country Department II (Bhutan, India and Nepal) Population and Huaman Resources Operations Division CURRENCY EQUIVALENTS (As of July 1996) Currency Unit = Rupee Rupee 34.70 =US$ 1.00 Rupee 1.0 US$ 0.0288 METRIC EQUIVALENTS 1 Meter (m) 3.28 Feet (ft) 1 Kilometer 0.62 Miles GOVERNMENT FISCAL YEAR April 1 - March 31 ABBREVIATIONS AND ACRONYMS ADGHS Assistant Director General of Health Services AFB Acid Fast Bacilli AIDS Acquired Immunodeficiency Syndrome ARI Annual Risk of Infection BCG Bacilli of Calmette and Guerin BRS Basic Radiological System CDC Centers for Disease Control and Prevention CHC Community Health Center CHEB Central Health Education Bureau DALYs Disability Adjusted Life Years DANIDA Danish Development Agency DDG Deputy Director General DGHS Director General of Health Services DHO District Health (Medical) Officer DOT Directly-Observed Therapy DTC District Tuberculosis Center DTO District Tuberculosis Officer E Ethambutol GOI Government of India H or INH Isoniazid - ii - ABBREVIATIONS AND ACRONYMS (Continued) HIV Human Immunodeficiency Virus IDA International Development Agency IMA Indian Medical Association LCC Long Course Chemotherapy LSHTM London School of Hygiene and Tropical Medicine MIS Management Information System MO Medical Officer MOHFW Ministry of Health and Family Welfare MPHW Multi-Purpose Health Worker NGO Non-Governmental Organization NTI National Tuberculosis Institute NTP National Tuberculosis Control Program ODA Overseas Development Administration PHC Primary Health Center PHI Peripheral Health Institutions PPD Purified Protein Derivative PPF Project Preparation Facility R Rifampicin RNTP Revised National Tuberculosis Control Program S Streptomycin SCC Short Course Chemotherapy SIDA Swedish International Development Agency STO State Tuberculosis Officer STDTC State Tuberculosis Demonstration and Training Center STLS Senior Tuberculosis Laboratory Supervisor STS Senior Tuberculosis Supervisor T Thiacetazone TAI Tuberculosis Association of India TB Tuberculosis TRC Tuberculosis Research Center TU Tuberculosis Unit VHAI Voluntary Health Association of India WHO World Health Organization Z Pyrazinamide Vice President: Joseph Wood Director: Robert Drysdale Division Chief: Richard Skolnik Staff: Maria Donoso Clark - iii - DEFINITIONS Acid Fast Bacilli: Mycobacterium (M.) tuberculosis, unlike other bacteria, cannot readily be stained by the Gram stain method. A harsh staining procedure is required. Carbol-fuchsin, a red dye, is taken up and retained after washing in an acid-alcohol solution. Thus, the bacteria of this genus are referred to as Acid Fast Bacilli. Annual Risk of Infection: The annual risk of infection tells us the probability that any individual will be infected or re-infected in one year with M. tuberculosis, causative agent of human tuberculosis derived from human sources. The annual risk of infection has become the standard indicator of the tuberculosis burden in a community. BCG: An attenuated strain of M. bovis (or bovine type M. tuberculosis). Drs. Albert Calmette and Camille Guerin started making subcultures every three weeks of the virulent organism in 1906 in Lille, France. Twelve years later in 1918 the attenuated strain was isolated. It was first used as a vaccine in 1921. Case Detection: There are two types of case detection, active and passive. Active Case Detection refers to community activities in which the tuberculosis health services are actively search for new TB cases through screening examinations (radiographic or Passive Case Detection refers to community activities in which the public health and medical services, including the regularly constituted tuberculosis control staff, detect new TB cases among the population who present themselves with symptomatic complaints. - iv - DALYs: Disability Adjusted Life Years. DALYs represent the sum of years lost both from premature death and from disability associated with disease and injury. Directly ObservedTreatment (DOT): An anti-tuberculosis drug treatment which is taken in the presence of, and is directly observed by a health care worker or other trained person, and is duly recorded in the patient's treatment card. DOTS Strategy: The WHO strategy or DOTS--directly-observed treatment, short-course--is designed to make a significant impact in slowing down the TB cycle of infection. The major technical features of the strategy are: (a) targeting the infectious TB sub- group of smear-positive individuals through passive case finding; (b) using sputum examination for diagnosis and treatment evaluation; (c) prescribing a six- to eight-month, multi-drug, SCC treatment regimen; (d) applying directly observed Treatment (DOT) in case management; and (e) emphasizing treatment completion and cure of TB patients and cohort analysis of results through simple registers at the sub-district level. Epidemiology: The study of the distribution and determinants of diseases and injuries in human populations. It is concerned with the frequencies and types of illnesses and injuries in groups of people and with the factors that influence their distribution. Incidence: Number of new cases of a disease or condition over a period of time as a proportion of the population at risk at midpoint. Incidence means "new" and is a direct indicator of risk. Long-CourseChemotherapy (LCC): Drug treatment for tuberculosis, recommended by the World Health Organization (WHO) Expert Committee on Tuberculosis in 1974. It's a chemotherapy regimen that is administered for twelve to eighteen months and uses fewer and cheaper drugs, such as, isoniazid, streptomycin and thiacetazone. - v - Prevalence: Number of cases of a disease or condition at a given point in time as a proportion of the total population. Prevalence means "all" and is used by health planners to assess workload and service delivery needs. Revised National Tuberculosis The new approach for the National Tuberculosis ControlProgram (RNTP): Control Program adopted by the Ministry of Health and Family Welfare in 1992. Its primary features include: (a) strengthening and reorganizing the Central TB Control unit; (b) adopting new and more rigorous methods for diagnosis, treatment and monitoring of patients, with emphasis on their cure; (c) decentralizing service delivery to the periphery; (d) strengthening training and research capacity; (e) targeting infectious, smear-positive cases; (f) providing SCC with DOT treatment; and (g) introducing a rigorous system of patient recording and monitoring through patient registration books and treatment cards. Short-Course Chemotherapy (SCC): Tuberculosis treatment that lasts from six to eight months, using multiple and more potent drugs, such as, isoniazid, rifampicin, ethambutol and pyrazinamide. Short-Course Chemotherapy converts most patients to smear negative faster than the long course chemotherapy and more effectively due to higher cure rates and higher compliance. It leads to a more rapid reduction in the risk of infection and incidence of clinical tuberculosis. Smear-NegativePatient: A tuberculosis patient with radiographic abnormalities consistent with active pulmonary tuberculosis, at least three negative sputum specimen, (for the Acid Fast Bacilli) and decision by a physician to treat with a full curative course of anti-tuberculosis chemotherapy. Smear-PositivePatient: A tuberculosis patient with two sputum specimen positive for the AFB, or with one sputum specimen positive for the AFB and radiographic abnormalities consistent with active pulmonary tuberculosis. - vi - INDIA PROPOSED TUBERCULOSIS CONTROL PROJECT TABLE OF CONTENTS PAGE NO. CREDIT AND PROJECT SUMMARY ....... ...................... ix I. INTRODUCTION .1 A. The Health Sector in India .1 B. The Epidemiology of Tuberculosis .1 II. TUBERCULOSIS IN INDIA . 3 A. The Current Situation .3 B. The National Tuberculosis Control Program .4 C. External Assistance to the NTP .6 D. Lessons from Experience .7 E. Country Assistance Strategy and Rationale for IDA Involvement.... 8 III. THE PROJECT .9 A. Background .9 B. Project Strategy .9 C. Project Scope .9 D. Project Goal and Objectives.10 E. Policies and Strategies.11 F. Project Description .13 * Improving the quality, access and outcomes of Tuberculosis treatment.13 * Developing institutional, operational and research capacity and enhancing technical, managerial and interpersonal skills. 16 * Developing information, education and communication, and promoting outreach activities and community involvement . 23 This report is based on an appraisal mission that visited India on June, 1996. on the work carried out throughpilot projects during the past two years, and on proposals and reports submitted by the Ministry of Health and Family Welfare (MOHFW). The mission comprised Ms. Maria Donoso Clark (Senior Anthropologists and Mission Leader), Kevin Casey (Sr. Implementation Specialist), Larry Geiter (International Union Against TB and Lung Diseases, IUATLD), Fabio Luelmo (Medical Officer, WHIO-Geneva),Laurie Krieger (Social Issues Consultant), and Raj Kumar (Public Health Specialist, New Delhi Office). Significant contribution to project preparation was provided by several members of the WHO Global Tuberculosis Plrogram,particularly Richard Bumgarner, Paul Nun, F. Luelmo, and Drs. Karl Styblo (WHO Consultant).