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Challenges in Implementation of the ANISA Protocol at the Odisha Site in India

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Challenges in Implementation of the ANISA Protocol at the Odisha Site in India SUPPLEMENT Challenges in Implementation of the ANISA Protocol at the Odisha Site in India Radhanath Satpathy, MD,* Pritish Nanda, MPH,* Nimai C. Nanda, MD,† Himadri B. Bal, PhD,* Ranjita Mohanty, BDS,* Archana Mishra, MSc,* Tapoja Swain, MSc,* Keshab C. Pradhan, MBA,* Kalpana Panigrahi, PhD,‡ Ambarish Dutta, PhD,* Pravas R. Misra, MVSc,* Sailajanandan Parida, MD,§ and Pinaki Panigrahi, MD‡ antibiotic resistance and risk factors for neonatal infections. The Background: The Aetiology of Neonatal Infection in South Asia (ANISA) first phase of the study involves establishment of community- study is being carried out at 5 sites across Bangladesh, India and Pakistan, based pregnancy, birth and neonatal surveillance for identifying generating in-depth information on etiologic agents in the community setting. cases of possible serious bacterial infection (pSBI) in the 0–59 day Pregnancies are identified, births are registered and young infants are followed age group and collecting specimens for etiologic evaluation using up to 59 days old with regular assessments for possible serious bacterial infec- blood culture and state-of-the-art molecular techniques. Crucially, tion following a generic protocol. Specimens are collected from suspected controls are also enrolled to identify natural colonizers that do not cases. This article describes the challenges in implementing the generic ANISA produce disease.1,2 protocol and modifications made to accommodate the Odisha site, India. The Odisha state site research hubs are located in Rourkela Challenges: Primary challenges in implementing the protocol are the large and Bhubaneswar in eastern India, areas that continue to record geographic area, with a population of over 350,000, to be covered; assessing very high infant and neonatal mortality.3 The 2 sites were chosen to young infants at home and arranging timely transport of sick young infants participate in ANISA because of their diversity, including coastal, to study hospitals for physician confirmation of illness; and specimen col- rural, tribal, mining and periurban areas, as well as neonatal disease lection and treatment. A large workforce is deployed in a 3-tier system in the prevalence. The site investigators have previous experience con- field, while clinical, microbiology, laboratory and data management teams ducting large-scale community and hospital-based surveillance and collaborate dynamically. Mobile phones with text message capability, inte- intervention studies among neonates.4–8 Established rapport with gration with the Odisha State government’s health system, involvement of the state government health systems and availability of a trained local communities and strict monitoring at different levels have been critical workforce in the community, along with facilities for data manage- in addressing these challenges. ment, microbiological analyses and long-term storage of biological Conclusion: This article describes the challenges and modalities adopted specimens, were considered major strengths of the site. This article to collect complex and accurate data on etiology, timing of disease and outlines the diverse nature of the communities and the associated associated factors for community-acquired neonatal infections. Attention to operational, socio-cultural and scientific challenges faced while local culture and customs, training and employing community level workers implementing the ANISA protocol at Rourkela and Bhubaneswar and supervisors, involving existing government machinery, using technol- in Odisha. ogy (cell phones), and uninterrupted systematic monitoring are critical for implementing such complex protocols that aim to collect population-based data to drive policy. STUDY SITES AND POPULATION The state of Odisha, home to 3.4% of India’s population, Key Words: neonatal, surveillance, pSBI, etiology, ANISA, Odisha, Rour- records the second-highest infant mortality rate (62/1000 live births) kela, Bhubaneswar among the 29 states and 11 union territories in the country.3 Odisha (Pediatr Infect Dis J 2016;35:S74–S78) is divided into 30 districts and each district is divided into blocks, with a population of approximately 100,000 in each block. Odisha’s population density is 265/km2, and its birth rate is 20/1000 popula- tion.9 The 2 study hubs are located in the major cities of Rourkela, in he Aetiology of Neonatal Infection in South Asia (ANISA) Sundargarh District, and Bhubaneswar, in Khordha District, where Tstudy aims to identify the incidence, timing, etiologic agents, the neonatal mortality rates are 39 and 46/1000 live births, respec- tively (Fig. 1 and Table 1).9 These 2 areas are about 500 km apart, and their inhabitants are diverse in ethnic, socio-cultural, envi- Accepted for publication January 10, 2016. From the *Asian Institute of Public Health, Bhubaneswar, Odisha, India; †Ispat ronmental, occupational and economic characteristics. The study General Hospital, Rourkela, Odisha, India; ‡Center for Global Health and area in Rourkela covers about 480 km2 and in Bhubaneswar 161 Development, College of Public Health, University of Nebraska Medical km2. The 105 study units in the Rourkela site have a total popu- Center, Omaha, Nebraska; and §Sri Ramachandra Bhanj Medical College, lation of 204,000, and the 75 study units at the Bhubaneswar site Cuttack, Odisha, India. The ANISA study is funded by the Bill & Melinda Gates Foundation (Grant No. have a population of 156,000. These units comprise 3 to 7 villages OPPGH5307). The authors have no other funding or conflicts of interest to with populations of 600–1200 each. At the time of study initiation, disclose. there were 36,718 and 25,677 married women of reproductive age Address for correspondence: Pinaki Panigrahi, MD, PhD, Center for Global (13–49 years) in Rourkela and Bhubaneswar, respectively, for a total Health and Development, College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska 68198. E-mail: [email protected]. of 62,395 women eligible for enrollment in ANISA. Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. This is an Villages around the Rourkela site are spread over hilly and open-access article distributed under the terms of the Creative Commons mining areas of Lathikata and Kuarmunda Blocks, with indige- Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permis- nous tribes predominating in the population. Many small villages sible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially. are dispersed in the study area, with the population living a tra- ISSN: 0891-3668/16/3505-0S74 ditional lifestyle with minimal outside interaction. The villagers DOI: 10.1097/INF.0000000000001112 earn their livelihood from forestry, rearing animals and raising S74 | www.pidj.com The Pediatric Infectious Disease Journal • Volume 35, Number 5, Supplement 1, May 2016 The Pediatric Infectious Disease Journal • Volume 35, Number 5, Supplement 1, May 2016 Challenges in Odisha Site, India FIGURE 1. Population-based study areas in the districts of Sundargarh and Khorda in Odisha state. free. Capital Hospital, a large multispecialty government facil- TABLE 1. Neonatal Health Indicators in India and in ity in the city of Bhubaneswar, and Ispat General Hospital, an Odisha State Indian government undertaking with the steel industry in Rour- kela, serve as the research hubs for ANISA. Indicator India Odisha Neonatal mortality rate/1000 live births* 33 39 TRAINING AND RECRUITMENT OF PERSONNEL Infant mortality rate/1000 live births* 47 59 <5 mortality rate/1000 live births* 59 79 Anganwadi (meaning “courtyard shelter”) Centers have Crude birth rate/1000 population* 21.6 19.8 been functional for more than 4 decades in our study areas, pro- Current use of contraception (%)† 64.0 59.4 viding preschool mid-day meals, assessing nutritional status of Facility delivery rate (%)‡ 72.9 75.5 children, and acting as a common place for health education, *Census of India, 2013. immunization, minor health check-ups and referral services. †National Fertility Health Survey 3 (2005–2006). Female, high-school (or higher) educated Anganwadi workers are ‡Coverage Evaluation Survey 2009, UNICEF. from the same or nearby villages and have been critical partners in the implementation of ANISA in Odisha, particularly in building arid crops. Some of those who live close to townships work rapport with families and birth registration. A new cadre of vil- for daily wages, and others have salaried employment in local lage-level workers, Accredited Social Health Activists (ASHAs), coal and iron mines. In contrast, inhabitants of Balianata and has been introduced in the area and they are also part of the exist- Balipatana Blocks in Khordha District in the Bhubaneswar site ing community health structure. The ASHAs and the Anganwadi depend on irrigated agriculture and work in government offices workers were incorporated into the ANISA project design to help and small industries. They are relatively more affluent and live maintain regular surveillance and facilitate bringing pregnant in densely populated villages that are close to each other. Apart women to facilities for delivery. Both the Anganwadi workers and from primary and community health centers, each site has one ASHAs work in concert with our dedicated community health tertiary care municipal hospital that provides most health care for volunteers (CHVs). © 2016 Wolters Kluwer Health, Inc. All rights reserved. www.pidj.com
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