Brief Summary Hypertension is a major public health problem in Nepal, with substantial gaps in awareness, treatment, and control, particularly in rural and semi-urban settings. Nepal has adopted the WHO Package of Essential Non-Communicable Diseases (PEN) to strengthen facility-based hypertension care; however, persistent community- and system-level barriers limit its effectiveness.

This study evaluates a Female Community Health Volunteer (FCHV)-led, community-based hypertension prevention and control intervention in Namobuddha Municipality, Kavrepalanchowk District, Nepal. The study uses a hybrid type II effectiveness-implementation cluster randomized controlled trial design to assess both implementation outcomes and clinical effectiveness. Twelve public primary healthcare facilities are randomized (1:1) to intervention or routine care. Implementation outcomes are assessed using the RE-AIM framework (Reach, Effectiveness, Adoption, and Implementation). The primary effectiveness outcome is change in mean systolic blood pressure at three months. Secondary outcomes include diastolic blood pressure, hypertension control status, hypertension knowledge, dietary behavior, medication adherence, and body mass index. The intervention mobilizes trained FCHVs to deliver group-based blood pressure monitoring, structured health education, lifestyle counseling, medication adherence support, and referral linkages to primary healthcare facilities.

Study design: The investigators will conduct a Hybrid type II effectiveness-implementation design focusing on implementation outcomes while also collecting effectiveness outcomes as they relate to the uptake or fidelity of the intervention. A mixed-method approach will be used. The investigators will conduct a cluster randomized controlled trial among 520 participants, clustered within 12 health facilities. Among the participants of the intervention arm, the investigators will collect quantitative data on adoption, implementation and reach. The investigators will conduct in-depth interviews with 8-16 patients, at least 2 FGDs with FCHVs and at least 4 Key Informant Interviews (KIIs) with health workers to understand implementation outcomes. The investigators will maintain qualitative tracking logs to document meetings with FCHVs and healthcare workers.

Study site: In partnership with the Ministry of Health and Population (MoHP), the World Health Organization (WHO), and the NCD Flagship Initiative, and with funding from the Norwegian government, Bagmati province has initiated the Hypertension care cascade model in the Kavrepalnchowk district. In this context, our research aims to support the model's objectives by monitoring treatment outcomes and control rates at every stage of care in the Kavre district. The study will involve 12 basic health facilities in Namobuddha municipalities of Kavrepalnchowk, where approximately 82 female community health volunteers (FCHVs) are actively engaged. The selection of the study district and municipalities was done in consultation with WHO Nepal and Nepal Health Research Council, taking into consideration national priorities, Norad priorities, and ongoing NCD care activities in the district.

Study Population: At the facility level, the investigators will include basic health facilities that have implemented PEN, excluding those who are not within the network of the Nepal government health system. At the patient level, inclusion criteria will be: i) 30-75 years old ii) have a high blood pressure of 130/80 mmHg, iii) are able to provide informed consent. Exclusion criteria will include: severe illness requiring bed-rest, and pregnant women due to their special health needs.

Intervention :

We propose a community-based hypertension intervention in Namobuddha Municipality, leveraging Female Community Health Volunteers (FCHVs) as frontline implementers. A total of 34 FCHVs will each form a group of 7-16 participants and conduct one-hour, bi-monthly sessions over three months. Sessions will include:

Blood pressure monitoring Structured health education on hypertension and its risk factors Counseling on lifestyle modification Support for medication adherence Referral to primary care for participants with uncontrolled blood pressure

FCHVs are selected due to their trusted status and strong community presence, which facilitate participant engagement and behavior change. Evidence from Nepal and other settings demonstrates that community health workers are effective agents for hypertension prevention and control. Regular blood pressure monitoring raises awareness and promotes timely care-seeking, while structured education grounded in Social Cognitive Theory enhances knowledge, self-efficacy, and peer-supported behavior change . The group-based delivery model integrates behavioral and clinical interventions in a low-cost, sustainable framework.

Implementation Strategies

Implementation will follow an Implementation Research Logic Model (IRLM) to align strategies, mechanisms, and expected outcomes. Development of these strategies included:

Consultations with health workers and municipal health coordinators Cognitive interviews with FCHVs from neighboring municipalities Meetings with federal, provincial, and local government authorities These consultations informed locally adapted intervention materials, including flip charts and other literacy-appropriate tools, designed to match FCHVs' skills, workload, and the sociocultural context.

The implementation strategies are designed to address key barriers and leverage facilitators identified during formative assessments and prior evidence on FCHV-led interventions:

Capacity Building: A one-time, three-day competency-based training to strengthen FCHVs' skills in blood pressure measurement, behavior change communication, documentation, and goal setting.

Technical and Clinical Support: Provision of digital automated blood pressure monitors and literacy-appropriate materials to enable accurate measurement and effective education delivery.

Coalition Building: Formation of FCHV-led hypertension groups meeting twice monthly to support lifestyle changes, medication adherence, and self-care.

Community-Facility Linkages: Monthly coordination and referral meetings between FCHVs and health facility in-charges to strengthen referral systems, enhance communication, and create feedback loops for problem-solving.

Tools and data collection: Quantitative data will be collected using face-to-face interviews administered by trained research assistants using standardized questionnaires adapted from the WHO STEPS survey , Hypertension Knowledge, Hill bone compliance , Dietary quality questionnaire and entered into REDCap. Blood pressure will be measured using a standardized protocol. Qualitative data will be collected through supportive process documentation to inform interpretation of implementation outcomes.

Blood pressure will be taken during baseline and endline. The investigators will be using both quantitative and qualitative tools to measure our primary outcomes. The investigators will conduct In-depth interviews (IDIs) and Focus group discussion (FGDs) and transcribe all the discussions and interviews into Nepali. The principal investigators and local principal investigator then independently review the transcripts against the audio recording for potential discrepancies or incomplete data. The investigators will conduct abductive analysis, using first inductive codes (e.g., emerging from the data) and transposing these into deductive REAIM domain. RAs will keep field notebooks to document observed behaviors of providers and patients relevant to implementation.

For qualitative information collection, the investigators will develop an IDI guide based on previous literature for qualitative study.

Data analysis:

1. The investigators will compute estimates of adoption, implementation, reach and maintenance, with appropriate 95% confidence intervals. Reach is defined as % of FCHVs implementing the program will participate in monthly meetings; at Client level: percent of the hypertensive patients in the community are aware of their high BP status. Adoption is defined as % of the health facilities asked to participate in adopting the program i.e. FCHVs complete the initial training session. Program implementation is defined as % of the health facility will implement a minimum standard to program implementation, measured by: (1) healthcare workers conduct monthly meetings; (2) first home visits by FCHVs to the target clients; and (3) FCHV submit monthly reports. In addition, the investigators will explore facilitators and barriers to implementation.
2. For qualitative FGDs and interviews, the investigators will conduct abductive analysis36, using first inductive codes (e.g., emerging from the data) and transposing these into deductive CFIR constructs. RAs will keep field notebooks to document observed behaviors of providers and patients relevant to implementation.
3. The baseline characteristics will be presented as the mean (standard deviation) or, median (interquartile) for continuous; and frequency (%) for categorical variables. Primary analyses of the outcome, mean systolic BP at 3 months using paired t-test.

The investigators will conduct a mixed-methods assessment of the implementation outcomes by combining data from quantitative tools and from in-depth interviews.

Inclusion Criteria:

• 30 -75 years old
• have a high blood pressure of 130/80 mmHg or under hypertension medication
• are able to provide informed consent.

Exclusion Criteria:

• severe illness requiring bed rest, and
• pregnant women, due to their special health needs.