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Gender-based ViolenceNCT04081441

Impacts of Clean Cookstoves and Empowerment Training on Women's Health in Refugee Settings

A study testing Inyenyeri clean cookstove and fuel system and I-ACT (Individual, Agency-Centered Training) workshop in people with Gender-based Violence and Adherence, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Rwanda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Inyenyeri clean cookstove and fuel system and I-ACT (Individual, Agency-Centered Training) workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,555 participants
Where
1 siteRwanda
Study dates
1 Aug 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Rwanda1 site

  • Plan International, Rwanda

    Kacyiru, Kigali, KG 546ST1

Other trials in Rwanda

About this study

Official title: 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).

Read the 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.

Being tested
Inyenyeri clean cookstove and fuel system, I-ACT (Individual, Agency-Centered Training) workshop
Keywords
gender-based violence, intimate-partner violence, empowerment, food insecurity, humanitarian settings, depression, fuel use, clean cookstoves
Medical subject headings
Empowerment, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inyenyeri clean cookstove and fuel systemDevice

    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

  • I-ACT (Individual, Agency-Centered Training) workshopBehavioural

    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)

Study groups in NCT04081441
Study groupRoleWhat they receive
Inyenyeri clean cookstove/fuelExperimentalA tier 4 clean Mimi-moto cookstove/pellet system
Receives: Device: Inyenyeri clean cookstove and fuel system
I-ACT behavioral empowerment interventionExperimentalA 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
Receives: Behavioral: I-ACT (Individual, Agency-Centered Training) workshop
Cookstove and I-ACT empowermentExperimentalAccess to both the clean cookstove system and I-ACT empowerment training
Receives: Device: Inyenyeri clean cookstove and fuel system; Behavioral: I-ACT (Individual, Agency-Centered Training) workshop
I-ACT Waitlisted controlOtherThese households include those that were offered cookstoves after 6 months (from baseline) and are waitlisted to receive the I-ACT intervention
Receives: Device: Inyenyeri clean cookstove and fuel system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. 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.

    Measured: 6 months

  9. Number of participants reporting increased grit

    Changes in grit (Grit scale (Duckworth, et al)) as a result of the empowerment intervention.

    Measured: 6 months

  10. 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.

    Measured: 6 months

Secondary outcomes (1)

  1. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2019
  2. Study start1 Aug 2018
  3. Primary completion30 Dec 2019
  4. Study completion31 Dec 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
In this natural experiment, we have two connected randomized intervention deployments. The cookstove/fuel program was randomly rolled out to 750 households in Kigeme camp over a 6-month period (September 2018-March 2019) by Inyenyeri (a Rwandan social business). A second intervention (I-ACT empowerment training) was rolled out by Plan, International (December 2018-March 2019). I-ACT was deployed to women and their male partners (if applicable and available). After March 2019, the cookstove/pellet program was available to the whole camp. Assessments of impacts are done at 6 months after deployment of the interventions. Due to the staggering of the intervention roll-outs, the midline follow-up includes a six-month follow-up of the cookstove deployment and approximately 2-3 months of the I-ACT intervention and includes both partnered and non-partnered women. The 12-month assessment includes a 6-month follow up of the I-ACT empowerment intervention for partnered women only.
Masking
None (open label)
Enrolment
1,555 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04081441
Sponsor's protocol ID
7806
Status last verified
Aug 2022
First submitted
5 Aug 2019
Last updated
10 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data from this sample on social networks will be shared with colleagues at Boston College

Publications

  • Kalra N, Habumugisha L, Shankar A. Impacts of an abbreviated personal agency training with refugee women and their male partners on economic empowerment, gender-based violence, and mental health: a randomized controlled trial in Rwanda. BMC Public Health. 2024 May 14;24(1):1306. doi: 10.1186/s12889-024-18780-8.

    PubMed 38745312

Questions about this trial

What is this clinical trial studying?

A study testing Inyenyeri clean cookstove and fuel system and I-ACT (Individual, Agency-Centered Training) workshop in people with Gender-based Violence and Adherence, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Rwanda.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Aug 2022. 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 Rwanda. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rates of gender-based violence (time frame: 6 months). The study lists 10 primary outcomes in all. 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 NCT04081441, 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 10 Aug 2022.

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