Community Mobilization for High Blood Pressure

Recruiting at1 trial location

Overseen by Christopher O Olopade

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

Using a focused implementation research framework, the EPIS (Exploration, Preparation, Implementation and Sustainment) model in a type-2 hybrid design, the study will be conducted in 3 phases: 1) A pre-implementation phase that will use the Exploration and Preparation domains of EPIS to: a) explore barriers and facilitators of Clean Fuel- Clean- Stove (CF-CS) use, and b) develop a culturally-tailored CM strategy for CF-CS use; 2) An Implementation phase that will use the Implementation domain of EPIS to compare in a cluster RCT of 32 peri-urban communities (640 households), the effect of CM vs. a self-directed condition (i.e. receipt of information on CF-CS use without CM) on adoption of CF-CS use; and systolic BP reduction; 3) A post-implementation phase that will use the Sustainment domain of EPIS to evaluate the effect of CM strategy vs. self-directed condition on sustainability of the CF-CS use in 640 households across the randomly assigned 32 peri-urban communities in Nigeria. The Lagos State University College of Medicine (LASUCOM) working with the MOH will oversee research coordination in Nigeria.

Research Team

Olugbenga Ogedegbe, MD

Principal Investigator

NYU Langone Health

Christopher O Olopade

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for families in peri-urban Nigerian communities who primarily use kerosene, charcoal, or firewood for cooking. The primary cook must be a female without a paid housemaid, and the household should have 2 to 7 members. The key decision-maker at home must agree to participate and not plan to move within the next year.

Inclusion Criteria

I am a woman who does the cooking in my household.

Must not have a paid housemaid

Family size must be a minimum of 2 and no more than 7 members

Exclusion Criteria

Does not meet the inclusion criteria

Treatment Details

Interventions

• Community Mobilization (Behavioral Intervention)

Trial Overview The study tests if community mobilization (CM) can increase clean cookstove usage and reduce hypertension compared to just giving information without CM support. It's conducted in three phases: exploring barriers, implementing CM in a randomized trial of 640 households across 32 communities, then checking long-term sustainability.

Participant Groups

Group I: CM Intervention Group Experimental Treatment 1 Intervention

Cluster. RCT of 16 urban and rural communities. Community mobilizers and health education officers will facilitate use of CF-CS (bioethanol and LPG fuels/stoves) and educate households on HAP exposure throughout the intervention period

Group II: Self-Directed Group Active Control 1 Intervention

Receive information on CFCS use and education on HAP in 16 urban and rural communities; will not receive the CM intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco