Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention

Not Applicable

Active, not recruiting

• Conditions: Hypertension
• Interventions: Behavioral: Community Mobilization

• Registration Number: NCT05048147
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

This study will use CM to engage in the community dialogues, organize outreach facilitation, and advocacy for the adoption of bioethanol-based and liquified petroleum gas (LPG) CF-CS across participating households. The choice of CM strategy is deliberate because, unlike western culture, African cultures are largely based on communal hierarchy.

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-17
• Study Start: 2023-04-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2025-03
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

• Primary adult must be a female cook;
• Must not have a paid housemaid;
• Family size must be a minimum of 2 and no more than 7 members;
• Family must use Kerosene, charcoal, LPG, or firewood as primary cooking fuel;
• The person spoken to at enrollment must be the home key decision maker;
• Must have no plans for relocation in the next year.

Exclusion Criteria

• Does not meet the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM Intervention Group	Community Mobilization	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

Primary Outcome Measures

Name	Time	Method
Percent of Participants who have Adopted CF-CS at Baseline	Baseline	Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits.
Percent of Participants who have Adopted CF-CS at Month 12	Month 12	Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits.

Secondary Outcome Measures

Name	Time	Method
Change in Mean Systolic Blood Pressure from Baseline to Month 12	Baseline, Month 12	Blood pressure readings assessed with a validated automated BP device. At each visit, three readings will be taken by trained research coordinators using an automated BP monitor. The average of three BP readings will be used as the measure for each study visit.
Percent of Participants who Have Adopted CF-CS at Month 24	Month 24	Measure of sustainability. Adoption defined as utilization of the CF-CS for more than 50% of cooking activities based on the metric developed by the Global Alliance for Clean Cookstoves. All traditional stoves and the bioethanol-based CF-CS in the participating households will be equipped with the iButtons SUMs to assess their use. Trained study staff will collect iButton temperature data during household visits.

Trial Locations

Locations (2)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

NYU Langone Health; 🇺🇸 New York, New York, United States