FCHV-HTN Implementation Trial in Nepal

Summary

The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are:

1\. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels?

2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial.

3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy?

Participants will receive four follow-up group meetings or home visits every three months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.

Conditions

• Hypertension

Interventions

BEHAVIORAL

Community Health Worker Intervention

Trained CHWs will hold group meetings or home visits using a locally adapted manual for HTN management. CHWs will visit homes in their areas and measure BP. High BP clients will be taken to the nearest health center. CHWs will enroll individuals with preHTN and HTN and conduct 4 follow-up group meetings or home visits with them every 3 months. Participants will be invited to attend CHW lead group-based counseling. For those with uncontrolled HTN who have difficulty adhering to prescribed HTN management and not willing or able to attend group meetings, CHWs will conduct follow-up home visits. First meeting (about 90 minutes), CHWs will explain purpose of the meeting and discuss HTN and its consequences. CHWs will apply techniques to initiate dialogue and reflection regarding lifestyle modifications and choose goals based on PEN protocol-2, BP monitoring, and antihypertensive medication use. In subsequent meetings (about 60 minutes), the CHWs will measure BP and address ongoing problems.

Sponsors & Collaborators

• Dhulikhel Hospital

  collaborator OTHER

• Institute for Implementation Science and Health

  collaborator UNKNOWN

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Donna Spiegelman, ScD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-02

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Nepal

Study Locations