- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04081441
Impacts of Clean Cookstoves and Empowerment Training on Women's Health in Refugee Settings
August 9, 2022 updated by: Johns Hopkins Bloomberg School of Public Health
Impacts of Clean Cookstoves/Efficient Fuels Uptake and Empowerment Trainings on Women's Health and Well Being in Humanitarian Settings in Rwanda
The main objective of this study is to understand the links and outcomes of adoption of a cleaner cookstove/fuel and exposure to a personal empowerment training on women's health outcomes in a Congolese refugee camp in Rwanda, with a focus on gender-based violence (GBV).
Study Overview
Status
Completed
Conditions
Detailed Description
This randomized controlled trial examines the impacts of a phased-in integrated technology -behavior change intervention on women's health with a focus on gender-based violence.
In a population of approximately 1500 Congolese households in Kigeme refugee camp in Rwanda, two interventions are randomly deployed in the camp.
The first intervention is the Inyenyeri cookstove/pellet fuel system, a Tier 4 clean cookstove system; the second intervention is a behavior change intervention (referred to as I-ACT, Individual-Agency-Centered Training) designed to foster personal agency and empowerment, given to women and, if applicable, their male partner.
Analyses will be done with interviews on 1500 women (ages 18-45) from these households that may have received one, both or none of the interventions, either as the full sample or the sub-sample of partnered-only women.
Study Type
Interventional
Enrollment (Actual)
1555
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kigali
-
Kacyiru, Kigali, Rwanda, KG 546ST1
- Plan International, Rwanda
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Study participants are between the ages of 18 years - 45 years of age
- Reported as currently living in a refugee camp with no intention to relocate
- Has lived in any refugee camp for at least 1 year and can be interviewed in private
- Has the ability to give informed consent
Exclusion Criteria:
- Inability to provide informed consent
- Individuals having evidence of significant illness and/or are not able to engage fully in the surveys
- Women younger than 18 or over 45 years of age
- Those who have not lived continuously in a refugee camp setting for the past 12 months
- If two or more women live in a household, only one of these will be included in the study. The one responsible for fuel purchase/collection will be selected. If more than one woman is responsible for fuel collection, we will randomly choose one woman to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Inyenyeri clean cookstove/fuel
A tier 4 clean Mimi-moto cookstove/pellet system
|
The Inyenyeri cooking systems includes a tier 4 clean cooking system with biomass pellets that are purchased through the unconditional cash transfer program in the refugee camp
|
EXPERIMENTAL: I-ACT behavioral empowerment intervention
A culturally adapted 2-day personal empowerment workshop (based on the Individual, Agency-Centered Training (I-ACT) to women and modified, condensed 1-day training for their male partners, if applicable
|
The I-ACT (Individual, Agency-Centered Training) empowerment workshop consists of behavioral exercises drawn primarily from positive psychology, that provide the tools to foster a growth mindset by allowing participants to understand the link between their thoughts, beliefs, and past actions to their future actions.
Conducted in a workshop setting, this locally adapted version of the I-ACT curriculum consists of two days for women and a 1 day workshop for their male partners (as applicable)
|
EXPERIMENTAL: Cookstove and I-ACT empowerment
Access to both the clean cookstove system and I-ACT empowerment training
|
The Inyenyeri cooking systems includes a tier 4 clean cooking system with biomass pellets that are purchased through the unconditional cash transfer program in the refugee camp
The I-ACT (Individual, Agency-Centered Training) empowerment workshop consists of behavioral exercises drawn primarily from positive psychology, that provide the tools to foster a growth mindset by allowing participants to understand the link between their thoughts, beliefs, and past actions to their future actions.
Conducted in a workshop setting, this locally adapted version of the I-ACT curriculum consists of two days for women and a 1 day workshop for their male partners (as applicable)
|
OTHER: I-ACT Waitlisted control
These households include those that were offered cookstoves after 6 months (from baseline) and are waitlisted to receive the I-ACT intervention
|
The Inyenyeri cooking systems includes a tier 4 clean cooking system with biomass pellets that are purchased through the unconditional cash transfer program in the refugee camp
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of gender-based violence
Time Frame: 6 months
|
Change in gender-based violence (GBV) over time as assessed through an adapted ASIST-GBV screening tool to identify physical violence, sexual violence, harassment, emotional violence and reproductive coercion between non-partners and intimate partners in humanitarian settings.
|
6 months
|
Number of households reporting uptake and consistent use of clean cooking system and fuel
Time Frame: 6 months
|
Change in uptake and use of the clean cooking system as measured through pellet purchase and reported pellet use behavior
|
6 months
|
Number of participants reporting minor psychiatric disorders
Time Frame: 6 months
|
Changes in the number of participants reporting minor psychiatric disorders as determined by the General Health Questionnaire (GHQ-12) as a result of the empowerment intervention.
|
6 months
|
Number of participants reporting anxiety and depression
Time Frame: 6 months
|
Changes in the number of participants reporting anxiety and depression as determined by the Hopkins Symptom Checklist (HSCL) as a result of the empowerment intervention.
|
6 months
|
Number of participants reporting emotional symptoms of trauma
Time Frame: 6 months
|
Changes in the number of participants reporting emotional symptoms of trauma as determined by the Harvard Trauma Questionnaire (HTQ) as a result of the empowerment intervention.
|
6 months
|
Number of participants reporting increased economic and social empowerment
Time Frame: 6 months
|
Change in rates of reported uptake of economic activities (such as small businesses or savings) as well as participation in social groups and local training programs
|
6 months
|
Number of participants reporting reduced food insecurity
Time Frame: 6 months
|
Change in reported incidence and severity of food insecurity as determined through a culturally adapted modification of the food insecurity experience scale (FIES) associated with food-related distress during the past month
|
6 months
|
Number of participants reporting increased self-efficacy
Time Frame: 6 months
|
Changes in self-efficacy (as assessed by the New General Self-Efficacy Scale) as a result of the empowerment intervention.
|
6 months
|
Number of participants reporting increased grit
Time Frame: 6 months
|
Changes in grit (Grit scale (Duckworth, et al)) as a result of the empowerment intervention.
|
6 months
|
Number of participants reporting increased social agency
Time Frame: 6 months
|
Changes in social agency (as assessed by Ryff's psychological well-being scales) as a result of the empowerment intervention.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants reporting increased quality and quantity of social networks
Time Frame: 6 months
|
Changes in quality of social networks in the form of network size, network density and stove homophily resulting from either the empowerment training or the improved cookstove program as determined by reported social ties and characteristics of those social ties.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anita V Shankar, Ph.D., Johns Hopkins Bloomberg School of Public Health
- Principal Investigator: Naira Kalra, Ph.D., Johns Hopkins Bloomberg School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2018
Primary Completion (ACTUAL)
December 30, 2019
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
August 5, 2019
First Submitted That Met QC Criteria
September 4, 2019
First Posted (ACTUAL)
September 9, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7806
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data from this sample on social networks will be shared with colleagues at Boston College
IPD Sharing Time Frame
August 2019-January 2020
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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