Community-based HyPertension Control (CHPC) in Nepal: Cluster randomized implementation trial protocol

This study aims to evaluate the implementation i.e., reach, adoption, fidelity, and maintenance; and effectiveness on blood pressure reduction of implementation strategies to enhance uptake of community-based hypertension control intervention in Nepal. A cluster randomized, hybrid type III effectiveness-implementation trial. The study focuses on Reach, Effectiveness, Adoption, Implementation, and Maintenance of the RE-AIM framework implementation outcomes. We will conduct a cluster randomized trial in Sindhupalchowk district, randomizing 102 health facilities in the district into the CHPC intervention (n=51) and standard care control (n= 51) groups. The CHPC includes community-based BP monitoring, lifestyle counseling and medication adherence monitoring. The implementation strategies of CHPC intervention will include a) leadership support and ongoing program promotion, b) capacity building of healthcare workers and Female Community Health Volunteers (FCHVs) in hypertension management, c) FCHV group meetings and home visits, and d) creating social networks to promote shared learning. Participants (n=3,572, 35 in each of the 102 clusters) aged ≥30 years with BP ≥140/90mmHg and/or on medications will be recruited. Participants from intervention clusters will be assessed against those residing in the control communities. Implementation outcomes (reach, adoption, implementation and maintenance) will be assessed using data from the process evaluation in intervention health facilities. The evaluation will use a mixed-method approach. For effectiveness, the mean decrease in systolic BP in the intervention group compared to the control group will be assessed 12 months after the intervention begins. The cost-effectiveness of the intervention will also be assessed. We will conduct observations, periodic reflections, focused group discussions and key informant interviews to explore implementation outcomes. Qualitative methods will be informed by the Consolidated Framework for Implementation Research (CFIR) and analyzed using a rapid qualitative analytic approach and thematic analysis. This study will provide evidence for tested approaches and mechanisms for utilizing and embedding community health volunteers in hypertension care to mitigate hypertension burden and improve quality of life. 2; October, 2024. ClinicalTrials.gov NCT06081010 . Registered 12 October 2023, https://clinicaltrials.gov/study/NCT06081010