Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

NCT ID: NCT05416372

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2027-12-31

Brief Summary

The investigators hypothesize that communities in which religious leaders are provided with education about blood pressure and how to measure blood pressure will have lower overall average blood pressures than communities in which religious leaders do not receive education about blood pressure.

Detailed Description

This research is being done to determine whether the Religious Engagement in Health Intervention can reduce community blood pressure. The study is being conducted in the Northwestern Tanzania. 20 communities will be involved: 10 will be randomized to the Religious Engagement in Health Intervention arm, and 10 will be randomized to the control arm. The Religious Engagement in Health Intervention includes the following three evidence-based components: (1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of blood pressure, (2) equipping religious leaders to provide blood pressure teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and (3) community blood pressure screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control communities

Communities randomized to the control arm will receive a strengthening of the capacity to manage blood pressure at their local health center. Healthcare workers at the local health center will receive standard supplies, reference materials, and training in blood pressure measurement and management on-site. In the event of any stock-outs due to higher demand for antihypertensives during the trial implementation, the trial will temporarily provide these medications to primary health facilities until the Ministry of Health supply chain is restored. Of note, control communities will receive Religious Engagement in Health Intervention after the trial is complete.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Religious Engagement in Health Intervention communities

Communities randomized to the intervention arm will receive a strengthening of the capacity to manage blood pressure at their local health center plus Religious Engagement in Health Intervention for blood pressure (BP), which includes three evidence-based components; 1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of BP, 2) equipping religious leaders to provide BP teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and 3) community BP screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.

Group Type: EXPERIMENTAL

Religious Engagement in Health Intervention

Intervention Type: BEHAVIORAL

Religious Engagement in Health Intervention for blood pressure (BP) includes three evidence-based components: (1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of BP, (2) equipping religious leaders to provide BP teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and (3) community BP screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.

Interventions

Religious Engagement in Health Intervention

Religious Engagement in Health Intervention for blood pressure (BP) includes three evidence-based components: (1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of BP, (2) equipping religious leaders to provide BP teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and (3) community BP screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult ≥35 years of age
• Has lived in the community for ≥1 year
• Household identified for random sampling is primary residence: has slept in the household at least once in the past 2 weeks and considers this their primary residence

Exclusion Criteria

• First-degree relative from the same household already enrolled
• Relative of the same sex from the same household already enrolled

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer A Downs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Robert N Peck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Community

Wards, Mwanza, Geita, and Simiyu Regions, Tanzania

Site Status: RECRUITING

Countries

Tanzania

Central Contacts

Megan Willkens, BS

Role: CONTACT

maw4016@med.cornell.edu

646-962-8140

Lindsey Reif, MPH, PhD

Role: CONTACT

lir2020@med.cornell.edu

646-962-8140

Facility Contacts

Regional Medical Officer

Role: primary

0282500690

Other Identifiers

R01HL161673

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-06023670

Identifier Type: -

Identifier Source: org_study_id