Contemporary clinical trials · 2026
Protocol of a cluster randomized controlled trial of a village health worker care model to reduce cardiovascular disease risk among conflict-affected populations in eastern Myanmar.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Thwe Su Mon, Mon Myint Nan Ei, Goyal Ravi, Win Zin Mar, Long Michael, Myint Saw Kyaw, Kler Law Saw Sha, Zaw Nicholus Tint, Htoo Eindra, Phyo Aung Zay Yar, Traill Tom, Lee Catherine, Richards Adam
Аннотация
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in many conflict-affected countries including Myanmar. Humanitarian health systems lack evidence of effective and efficient strategies to achieve high coverage of medications proven to reduce CVD risk among forcibly displaced populations in rural areas. This manuscript describes the rationale and design of a cluster randomized controlled trial (cRCT) to test the impact of an integrated village health worker (VHW) care model on medication adherence and costs, among individuals with CVD risk factors living in areas of active armed conflict in eastern Myanmar.
METHODS: The hybrid effectiveness-implementation type 1 study centers on a cRCT that randomizes thirteen villages in rural Karen state to intervention and control groups. In intervention villages, mobile teams screen residents ≥40 years old for elevated CVD risk, medics initiate treatment with statins and anti-hypertensive medications, supported by a mobile clinical decision tool, and VHWs conduct monthly home visits to monitor blood pressure, adherence and side effects, and deliver medications. Control village residents receive usual facility-based care. The primary outcome is medication adherence; secondary outcomes include systolic blood pressure and predicted 10-year CVD risk. The study also evaluates the reach, acceptability, perceived sustainability and equity impacts of the intervention using the RE-AIM framework, and distributional cost-effective analysis.
DISCUSSION: This cRCT tests an innovative community-based care delivery model to strengthen cardiovascular disease management for villagers experiencing armed conflict. The study newly employs simulation-based power analysis, health equity metrics, implementation science and cost-effectiveness analysis in a humanitarian emergency. Trial registration numberNCT06819839, Date of registration: 2025-01-25.
METHODS: The hybrid effectiveness-implementation type 1 study centers on a cRCT that randomizes thirteen villages in rural Karen state to intervention and control groups. In intervention villages, mobile teams screen residents ≥40 years old for elevated CVD risk, medics initiate treatment with statins and anti-hypertensive medications, supported by a mobile clinical decision tool, and VHWs conduct monthly home visits to monitor blood pressure, adherence and side effects, and deliver medications. Control village residents receive usual facility-based care. The primary outcome is medication adherence; secondary outcomes include systolic blood pressure and predicted 10-year CVD risk. The study also evaluates the reach, acceptability, perceived sustainability and equity impacts of the intervention using the RE-AIM framework, and distributional cost-effective analysis.
DISCUSSION: This cRCT tests an innovative community-based care delivery model to strengthen cardiovascular disease management for villagers experiencing armed conflict. The study newly employs simulation-based power analysis, health equity metrics, implementation science and cost-effectiveness analysis in a humanitarian emergency. Trial registration numberNCT06819839, Date of registration: 2025-01-25.