Implementation of the community health system innovation project in three low- and middle-income countries: COHESION-I study protocol

Background The COmmunity HEalth System InnovatiON (COHESION) project (2016–2019) was a 4-year collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It conducted formative health system research using tracer chronic conditions, non-communicable diseases (diabetes and hypertension) and one neglected tropical disease per country (schistosomiasis in Mozambique, leprosy in Nepal and neurocysticercosis in Peru). Findings guided the co-creation of interventions to improve diagnosis and management through a participatory approach with communities, primary healthcare workers and regional health authorities. As a continuation of this effort, the research team initiated the COHESION Implementation project (COHESION-I) with two objectives: (1) implement and evaluate the contextspecific co-created interventions in Mozambique, Nepal and Peru (Component 1) and (2) adapt the COHESION approach to India, a country that did not benefit from a formative phase previously (Component 2). This protocol manuscript focuses on Component 1. Methods and analysis A mixed-methods, pre–post quasi-experimental design will be used, including quantitative, qualitative, economic and process evaluations. Each country will have three arms: (1) co-created and co-designed interventions; (2) only codesigned intervention and (3) the usual care arm. Data will be collected longitudinally over 18months to assess the effect of the interventions. The main outcomes include patient satisfaction (Patient Satisfaction Questionnaire Short Form), health system responsiveness (WHO responsiveness domains) and quality of life (EuroQol 5 dimensions 5 levels). The qualitative evaluation will explore how satisfaction is perceived among service users with chronic conditions and healthcare workers. Other outcomes per type of evaluation will be considered such as perceived value of health services, cost estimation and acceptability of the intervention components, among others. Ethics and dissemination Approvals were obtained from Ethics Committees of Universidad Peruana Cayetano Heredia (Peru), Universidade Eduardo Mondale (Mozambique) and Nepal Health Research Council (Nepal). Results will be disseminated through peer-reviewed publications and scientific conferences. Trial registration number NCT06989502.