NCT04081441

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,555

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 5, 2019

Last Update Submit

August 9, 2022

Conditions

Keywords

gender-based violenceintimate-partner violenceempowermentfood insecurityhumanitarian settingsdepressionfuel useclean cookstoves

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Number of participants reporting increased grit

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

    6 months

  • 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 Outcomes (1)

  • Number of participants reporting increased quality and quantity of social networks

    6 months

Study Arms (4)

Inyenyeri clean cookstove/fuel

EXPERIMENTAL

A tier 4 clean Mimi-moto cookstove/pellet system

Device: Inyenyeri clean cookstove and fuel system

I-ACT behavioral empowerment intervention

EXPERIMENTAL

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

Behavioral: I-ACT (Individual, Agency-Centered Training) workshop

Cookstove and I-ACT empowerment

EXPERIMENTAL

Access to both the clean cookstove system and I-ACT empowerment training

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

I-ACT Waitlisted control

OTHER

These households include those that were offered cookstoves after 6 months (from baseline) and are waitlisted to receive the I-ACT intervention

Device: Inyenyeri clean cookstove and fuel system

Interventions

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

Cookstove and I-ACT empowermentI-ACT Waitlisted controlInyenyeri clean cookstove/fuel

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)

Cookstove and I-ACT empowermentI-ACT behavioral empowerment intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plan International, Rwanda

Kacyiru, Kigali, KG 546ST1, Rwanda

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

EmpowermentDepression

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavioral Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

September 9, 2019

Study Start

August 1, 2018

Primary Completion

December 30, 2019

Study Completion

December 31, 2020

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

De-identified data from this sample on social networks will be shared with colleagues at Boston College

Shared Documents
ANALYTIC CODE
Time Frame
August 2019-January 2020

Locations