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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04081441
Other study ID # 7806
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date December 31, 2020

Study information

Verified date August 2022
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 1555
Est. completion date December 31, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Device:
Inyenyeri clean cookstove and fuel 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
Behavioral:
I-ACT (Individual, Agency-Centered Training) workshop
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)

Locations

Country Name City State
Rwanda Plan International, Rwanda Kacyiru Kigali

Sponsors (4)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Fundacion Plan International Espana, Global Alliance for Clean Cookstoves, World Bank

Country where clinical trial is conducted

Rwanda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of gender-based violence 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
Primary Number of households reporting uptake and consistent use of clean cooking system and fuel Change in uptake and use of the clean cooking system as measured through pellet purchase and reported pellet use behavior 6 months
Primary Number of participants reporting minor psychiatric disorders 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
Primary Number of participants reporting anxiety and depression 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
Primary Number of participants reporting emotional symptoms of trauma 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
Primary Number of participants reporting increased economic and social empowerment 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
Primary Number of participants reporting reduced food insecurity 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
Primary Number of participants reporting increased self-efficacy Changes in self-efficacy (as assessed by the New General Self-Efficacy Scale) as a result of the empowerment intervention. 6 months
Primary Number of participants reporting increased grit Changes in grit (Grit scale (Duckworth, et al)) as a result of the empowerment intervention. 6 months
Primary Number of participants reporting increased social agency Changes in social agency (as assessed by Ryff's psychological well-being scales) as a result of the empowerment intervention. 6 months
Secondary Number of participants reporting increased quality and quantity of social networks 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
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