HypertensionNCT05416372
Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities
A study testing Religious Engagement in Health Intervention in people with Hypertension, run by Weill Medical College of Cornell University at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Religious Engagement in Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,046 participants
- Where
- 1 siteTanzania
- Study dates
- 22 Jun 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- First-degree relative from the same household already enrolled
- Relative of the same sex from the same household already enrolled
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Religious Engagement in Health Intervention
- Keywords
- Religious Leaders, Community Engagement, Hypertension, Tanzania
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Religious Engagement in Health InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Religious Engagement in Health Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 12months
Secondary outcomes (19)
Change in Awareness of Hypertension
Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 12 months
Measured: Baseline; 12 months
Change in Awareness of Hypertension
Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 24 months
Measured: Baseline; 24 months
Change in Treatment of Hypertension
Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 12 months
Measured: Baseline; 12 months
Change in Treatment of Hypertension
Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 24 months
Measured: Baseline; 24 months
Change in Body Mass Index
Change in body mass index between baseline and 12 months.
Measured: Baseline; 12 months
Change in Body Mass Index
Change in body mass index between baseline and 24 months.
Measured: Baseline; 24 months
Change in Waist Circumference
Change in waist circumference between baseline and 12 months
Measured: Baseline; 12 months
Change in Waist Circumference
Change in waist circumference between baseline and 24 months
Measured: Baseline; 24 months
Change in Fruit Intake
Change in reported number of servings of fruits consumed per week between baseline and 12 months
Measured: Baseline; 12 months
Change in Fruit Intake
Change in reported number of servings of fruits consumed per week between baseline and 24 months
Measured: Baseline; 24 months
Change in Vegetables Intake
Change in reported number of servings of vegetables consumed per week between baseline and 12 months
Measured: Baseline; 12 months
Change in Vegetables Intake
Change in reported number of servings of vegetables consumed per week between baseline and 24 months
Measured: Baseline; 24 months
Change in Minutes of Physical Exercise Per Week
Change in minutes of physical exercise per week between baseline and 12 months
Measured: Baseline; 12 months
Change in Minutes of Physical Exercise Per Week
Change in minutes of physical exercise per week between baseline and 24 months
Measured: Baseline; 24 months
Reach of the Intervention
Percentage of religious leaders attending educational seminar and mentorship groups of 240 invited and number of community members reporting having blood pressure measured in the past year
Measured: 24 months
Effectiveness of the Intervention
Percentage of community members initiating anti-hypertensive medications
Measured: 24 months
Adoption of the Intervention
Percentage of community members report being educated about blood pressure by religious leader in past 12 months
Measured: 24 months
Maintenance of the Intervention
Percentage of community members report hearing blood pressure discussed in religious context in past 12 months; self-efficacy for blood pressure
Measured: 24 months
Mean Change in Community Systolic Blood Pressure
Before and 24 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.
Measured: Baseline; 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start22 Jun 2022
- Primary completion18 Jul 2025
- Study completionDec 2027 (estimated)
Why it stopped: Trial recruitment paused pending ongoing analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jennifer A Downs, MD, PhD, Principal investigator, Weill Medical College of Cornell UniversityRobert N Peck, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416372
- Sponsor's protocol ID
- 21-06023670
- Other IDs
- R01HL161673
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2022
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified research data sets that document, support, and validate our research findings will be made available under appropriate data-sharing agreements after the main findings from the final research data set have been accepted for publication.
Publications
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.
PubMed 40118143
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities
- ClinicalTrials.gov ID
- NCT05416372
- Acronym / sponsor ID
- 21-06023670
- Conditions
- Hypertension
- Keywords
- Religious Leaders, Community Engagement, Hypertension, Tanzania
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Trial recruitment paused pending ongoing analysis.
- Enrolment
- 16,046 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Religious Engagement in Health InterventionCommunities 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- First-degree relative from the same household already enrolled
- Relative of the same sex from the same household already enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Religious Engagement in Health InterventionReligious 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. | Behavioural | Religious Engagement in Health Intervention communities |
Primary outcome
Mean Change in Community Systolic Blood Pressure
Time frame: Baseline; 12months
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.
19 secondary outcomes
Change in Awareness of Hypertension
Time frame: Baseline; 12 months
Change in Awareness of Hypertension
Time frame: Baseline; 24 months
Change in Treatment of Hypertension
Time frame: Baseline; 12 months
Change in Treatment of Hypertension
Time frame: Baseline; 24 months
Change in Body Mass Index
Time frame: Baseline; 12 months
Change in Body Mass Index
Time frame: Baseline; 24 months
Change in Waist Circumference
Time frame: Baseline; 12 months
Change in Waist Circumference
Time frame: Baseline; 24 months
Change in Fruit Intake
Time frame: Baseline; 12 months
Change in Fruit Intake
Time frame: Baseline; 24 months
Change in Vegetables Intake
Time frame: Baseline; 12 months
Change in Vegetables Intake
Time frame: Baseline; 24 months
Change in Minutes of Physical Exercise Per Week
Time frame: Baseline; 12 months
Change in Minutes of Physical Exercise Per Week
Time frame: Baseline; 24 months
Reach of the Intervention
Time frame: 24 months
Effectiveness of the Intervention
Time frame: 24 months
Adoption of the Intervention
Time frame: 24 months
Maintenance of the Intervention
Time frame: 24 months
Mean Change in Community Systolic Blood Pressure
Time frame: Baseline; 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40118143Kavishe 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.
- Individual participant dataSharing planned: Yes. De-identified research data sets that document, support, and validate our research findings will be made available under appropriate data-sharing agreements after the main findings from the final research data set have been accepted for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Downs, MD, PhD principal investigator
Weill Medical College of Cornell University
Robert N Peck, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Religious Engagement in Health Intervention in people with Hypertension, run by Weill Medical College of Cornell University at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Community Systolic Blood Pressure (time frame: Baseline; 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.