Female Community Health Volunteer-led intervention for hypertension prevention and control in rural Nepal: A hybrid type 2 effectiveness-implementation design.

Hypertension is a leading cause of cardiovascular disease and premature mortality, disproportionately affecting low- and middle-income countries such as Nepal, where awareness, treatment, and control remain low. Female Community Health Volunteers (FCHVs) have been effective in maternal and child health programs and may support noncommunicable disease management. This hybrid type 2 effectiveness-implementation study evaluated the effectiveness and implementation outcomes of an FCHV-led intervention for hypertension prevention and control in rural Nepal. We conducted a cluster randomized controlled trial (ClinicalTrials.gov: NCT06163859) in Namobuddha Municipality, Nepal, randomizing 12 public primary healthcare facilities (1:1) to intervention or control arms. In intervention clusters, 34 FCHVs delivered a community-based hypertension program through bi-monthly group sessions over three months, including blood pressure monitoring, health education, lifestyle counseling, medication adherence support, and referral for uncontrolled hypertension. Implementation strategies were developed using an Implementation Research Logic Model and stakeholder consultations. Adults aged 30-75 years with elevated blood pressure were recruited through community screening. Implementation outcomes were assessed using the RE-AIM framework and effectiveness outcomes at three months. Analyses followed intention-to-treat principles using generalized estimating equations. Reach was 56.9%, with higher male participation than female participation (63.5% vs. 50.4%; p = 0.045). Adoption was 100% across facilities. Fidelity was moderate, with 76.5% attending at least four of six sessions and 71.1% of meetings achieving at least 70% attendance. No significant differences were observed in systolic blood pressure, diastolic blood pressure, or hypertension control. However, the intervention significantly improved hypertension knowledge and treatment adherence. The FCHV-led intervention was feasible and achieved moderate reach, universal adoption, and reasonable fidelity. Although blood pressure outcomes did not improve over three months, longer interventions with sustained support may improve clinical outcomes and support scale-up within Nepal's noncommunicable disease program.