1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sdesai1977@yahoo.com].
   


6. For how long will this data be available start date provided 30-09-2029 and end date provided 30-09-2035?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

India is undergoing an epidemiological transition. The non-communicable diseases (NCDs) have become the dominant cause of death and disability. However, there is still a need to continue to improve the nutrition-related outcomes related to reproductive-maternal-child-adolescent (RMNCH-A) health. Unfortunately, the coverage and quality of selected high-priority NCD and RMNCH services to support India’s citizens during this epidemiological transition remain low, especially in tribal-hard to reach areas. These high-priority services include screening and management of hypertension, diabetes, mental health disorders, sepsis-pneumonia in infants anemia among pregnant women. The reasons for low coverage are multiple including implementation challenges and somewhat suboptimal design of the existing delivery model that might not be a right fit for rural, tribal populations. Some of the design-related elements include a focus on clinic-based management instead of bringing care further near to patients’ homes, inadequate task shifting instead of collaborative care across multiple levels of service delivery, and a lack of integrated data systems that support care throughout the life cycle for multiple NCD and RMNCH diseases. Frontline health workers and doctors lack job aids and capacity that empower them to provide longitudinal care for multiple diseases prevalent in the population.   

This project primarily focuses on developing and evaluating a comprehensive primary health service delivery intervention that overcomes the aforementioned design-related shortcomings and that might be a better fit for India, especially for the rural-tribal parts. The proposed six-year project aims to create a demonstration field trial site to develop and evaluate an primary health care service delivery intervention to improve mortality rates through improvement in the coverage of selected, high-priority NCD and RMNCH health services in one tribal block of the Narmada district of Gujarat, India. The components of the service delivery model/intervention will consist of (1) a population-based approach with a focus on screening and management of prioritized NCD and RMNCH health services, (2) patient and family-centered care, (3) team-based collaborative care with linkage with secondary-tertiary level care facilities and (4) bringing care near to the homes of the citizens. The digital health solutions will be used to (1) enable and facilitate the aforementioned components of the primary health care service delivery model (2) empower frontline health workers, their supervisors and citizens through job aids and data systems to support longitudinal tracking, continuum of care across various levels of care. The scope of the intervention will be high-priority NCD and RMNCH health services that have the highest impact on reducing mortality and disability.  The intervention will be delivered by a cadre of middle-level providers (nurses) supported by village-level community health workers at the village level and doctors at facilities.

The effectiveness of this initiative will be measured through a two-arm, parallel cluster randomized controlled trial over the six years in 64 villages/clusters of tribal, Dediyapada block (population of 60,000, 95% indigenous/ tribal population) of Gujarat. There will be approximately 32 clusters/villages (approximately 800-1,000 populations in each village) in each arm.  The two primary outcomes will be (1) mortality and cardiovascular complications event rate among hypertension and diabetes cases who are more than 40 years of age (2) mortality rate among infants age four days to 365 days. Mortality rate will be measured through an ongoing death surveillance system. The secondary outcomes will include the coverage and quality of high-priority NCD, RMNCH and mental health services. Outcomes will be measured by conducting household surveys at baseline, midline and post-intervention which will be compared with usual practice in the control area where the current level of services provided by the government will continue.

The primary analysis will be done by “intention to treat”. For each of the primary and secondary outcomes, effect size (95% confidence interval), after adjustment if required, would be computed.

The study findings might be useful for strengthening the health and wellness centers as well as the Ayushman Bharat Digital Health Mission (ABDM) of the Government of India, especially for rural and tribal hard to reach populations.

This study will be done by investigators from SEWA Rural, a non-profit organization in Gujarat. SEWA Rural has been working towards improving health services in rural and tribal areas of Bharuch and Narmada districts of Gujarat in close partnership with the government since 1980.