Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

NCT05416372 | Suspended Results DMC

• 2 other identifiers: 21-06023670R01HL161673
• Study Type: interventional
• Target: 16,046
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Religious Leaders; Community Engagement; Hypertension; Tanzania

Outcome Measures

Primary Outcomes (1)

• Mean Change in Community Systolic Blood Pressure

  Before and 12 months after the intervention, investigators will estimate the true mean community BP by sampling 400 randomly selected adult community members (age ≥35 years) in each of the 20 communities.

  Baseline; 12months

Secondary Outcomes (19)

• Change in Awareness of Hypertension

  Baseline; 12 months

• Change in Awareness of Hypertension

  Baseline; 24 months

• Change in Treatment of Hypertension

  Baseline; 12 months

• Change in Treatment of Hypertension

  Baseline; 24 months

• Change in Body Mass Index

  Baseline; 12 months

Study Arms (2)

Control communities

NO INTERVENTION

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.

Religious Engagement in Health Intervention communities

EXPERIMENTAL

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.

Behavioral: Religious Engagement in Health Intervention

Interventions

Religious Engagement in Health Intervention 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.

Religious Engagement in Health Intervention communities

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Community

Wards, Mwanza, Geita, and Simiyu Regions, Tanzania

Location

Related Publications (1)

• Kavishe B, Willkens M, Mwakisole AH, Kalokola F, Okello E, Ayieko P, Kisanga E, Lee MH, Kapiga S, Downs JA, Peck R. A study protocol to engage religious leaders to reduce blood pressure in Tanzanian communities: A cluster randomized trial. Contemp Clin Trials. 2025 May;152:107884. doi: 10.1016/j.cct.2025.107884. Epub 2025 Mar 19.

  PMID: 40118143 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jennifer Downs, Associate Professor of Medicine
• Organization: Weill Cornell Medicine

jna2002@med.cornell.edu

1 646 962 8140

Study Officials

• Jennifer A Downs, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Robert N Peck, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20 communities will be stratified by population size (\< or ≥ 20,000) and randomly ordered within strata using a computerized random number generator. A statistician will generate a list of all of possible random permutations that allocate equal numbers of communities from each stratum to the intervention and to the control. Investigators will then invite two representatives from each of the 20 communities to a public randomization ceremony. During this ceremony, representatives will blindly choose numbered tennis balls from an opaque bag to identify the permutation of allocations that will be used.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: June 22, 2022
• Primary Completion: July 18, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 22, 2026
• Results First Posted: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available at the time of manuscript publication.
• Access Criteria: De-identified data on community blood pressures, including demographic and clinical data, will be made available under appropriate data-sharing agreements.

Locations

TA (1)