RT Journal Article SR Electronic T1 Why do strategies to strengthen primary health care succeed in some places and fail in others? Exploring local variation in the effectiveness of a community health worker managed digital health intervention in rural India JF BMJ Global Health JO BMJ Global Health FD BMJ Publishing Group Ltd SP e005003 DO 10.1136/bmjgh-2021-005003 VO 6 IS Suppl 5 A1 Gill Schierhout A1 Devarsetty Praveen A1 Bindu Patel A1 Qiang Li A1 Kishor Mogulluru A1 Mohammed Abdul Ameer A1 Anushka Patel A1 Gari D Clifford A1 Rohina Joshi A1 Stephane Heritier A1 Pallab Maulik A1 David Peiris YR 2021 UL http://gh.bmj.com/content/6/Suppl_5/e005003.abstract AB Introduction Digital health interventions (DHIs) have huge potential as support modalities to identify and manage cardiovascular disease (CVD) risk in resource-constrained settings, but studies assessing them show modest effects. This study aims to identify variation in outcomes and implementation of SMARTHealth India, a cluster randomised trial of an ASHA-managed digitally enabled primary healthcare (PHC) service strengthening strategy for CVD risk management, and to explain how and in what contexts the intervention was effective.Methods We analysed trial outcome and implementation data for 18 PHC centres and collected qualitative data via focus groups with ASHAs (n=14) and interviews with ASHAs, PHC facility doctors and fieldteam mangers (n=12) Drawing on principles of realist evaluation and an explanatory mixed-methods design we developed mechanism-based explanations for observed outcomes.Results There was substantial between-cluster variation in the primary outcome (overall: I2=62.4%, p<=0.001). The observed heterogeneity in trial outcomes was not attributable to any single factor. Key mechanisms for intervention effectiveness were community trust and acceptability of doctors’ and ASHAs’ new roles, and risk awareness. Enabling local contexts were seen to evolve over time and in response to the intervention. These included obtaining legitimacy for ASHAs’ new roles from trusted providers of curative care; ASHAs’ connections to community and to qualified providers; their responsiveness to community needs; and the accessibility, quality and appropriateness of care provided by higher level medical providers, including those outside of the implementing (public) subsystem.Conclusion Local contextual factors were significant influences on the effectiveness of this DHI-enabled PHC service strategy intervention. Local adaptions need to be planned for, monitored and responded to over time. By identifying plausible explanations for variation in outcomes between clusters, we identify potential strategies to strengthen such interventions.Data are available in a public, open access repository. Data are available on the Harvard Dataverse platform and can be accessed here: https://doi.org/10.7910/DVN/NSKFK2.