Clinical trial NCT06414070: Developing and Testing the Jenga Dada Intervention in Kenya
Official title: Jenga Dada: A Group-based Intervention to Prevent Partner Violence and Unintended Pregnancy Among Women in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Coercion
Intimate Partner Violence
Keywords: Reproductive coercion
Intimate partner violence
Contraceptive Use
Economic Abuse
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Population Council Kenya
name: Women's Empowerment Link
name: San Diego State University
First posted: 2024-05-16
Enrollment: 279
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled trial; stratified randomization based on urban/rural location
Primary purpose: TREATMENT

Brief summary: This study aims to work with women's economic empowerment groups within the community to address reproductive coercion and intimate partner violence and promote economic self-sufficiency among women (aged 15+ years). Based on the investigators' previous research in the United States, Bangladesh, and Kenya, the ARCHES (Addressing Reproductive Coercion in Health Settings) intervention is a highly effective clinic-based model to improve women's ability to use family planning and cope with abuse. Due to common requests for community-based support, content from the ARCHES intervention along with Girls Invest, an economic empowerment intervention implemented in the US and Nigeria, is being adapted to develop Jenga Dada, which means "Build a Woman Up" in Kiswahili, to be delivered to women's economic empowerment groups. The study will conduct formative research among women's economic empowerment group members, develop the Jenga Dada intervention, and conduct a pilot cluster randomized controlled trial to assess preliminary efficacy of the intervention on proximal outcomes (i.e., self-efficacy) and feasibility and acceptability.

Detailed description: Background: This project aims to develop and preliminarily evaluate an intervention, Jenga Dada, on its feasibility, acceptability, and efficacy to increase women's and girl's ability to successfully cope with reproductive coercion (RC), intimate partner violence (IPV), economic abuse, and promote reproductive health and economic self-sufficiency among women participating in economic empowerment groups in rural and peri-urban areas of Uasin Gishu county, Kenya. Jenga Dada is being developed as an innovative hybrid approach based on adaptation and integration of core content from two effective interventions: ARCHES (Addressing Reproductive Coercion in Health Settings) and Girls Invest. ARCHES is a clinic-based contraceptive counseling intervention designed and demonstrated to support voluntary contraceptive use and reduce physical IPV. ARCHES was originally designed in the U.S. and has been adapted to and evaluated, with positive results, in Bangladesh and Nairobi, Kenya, and is currently being adapted for scale-up in public sector facilities in Uasin Gishu county, Kenya. Girls Invest is a mobile health application (mHealth app) with integrated intervention modules on gender, IPV, and financial literacy demonstrated to be feasible and acceptable among adolescent girls in the U.S. and Nigeria (efficacy evaluation ongoing). Jenga Dada combines the information and education from ARCHES and Girls Invest in a group discussion-based curriculum, delivered by a local women's empowerment non-governmental organization (NGO), that aims to build social support for women, delivered within women's economic empowerment groups as they move towards economic self-sufficiency, reproductive autonomy, and violence-free relationships.

Intervention: Jenga Dada educational sessions will be delivered to existing women's economic empowerment group participants during regular meetings by a facilitator from a local NGO. Sessions will include education and facilitated group discussions on gender, RC, IPV, economic abuse, and financial literacy to bolster understanding, shift attitudes and norms, and support peers on these issues. One 60-minute guided group discussion will take place for each of the eight training modules during the weekly or bi-weekly women's economic empowerment group meetings.

Methodology: This pilot trial will test the hypothesis that women participating in Jenga Dada will report improved proximal outcomes regarding a) coping with economic abuse, IPV, and RC (self-efficacy to seek assistance for IPV and coping strategies to maintain contraceptive use in the face of opposition) and b) self-efficacy to seek support for violence experiences from women's economic group members. Study activities include formative research to inform development of Jenga Dada based on the lived experience of women and girls and implementers in this context, pilot testing, and evaluation of the effects of Jenga Dada on violence, reproductive health, and economic outcomes. The evaluation will occur in two phases via random assignment of 18 existing women's economic empowerment groups to receive either Jenga Dada or standard women's economic empowerment group programming with baseline and 4-month follow-up survey data collected (n=280 participants, ages 15+ years). Post-program qualitative data from participants and implementers will be collected and analyzed to evaluate the feasibility and acceptability of the program.

Eligibility criteria: Inclusion Criteria:

* Being a women's economic group member prior to baseline
* Aged 15 years and older
* Able to provide informed consent
* Not planning to move out of the area or leave the women's economic group in the next 4 months

Exclusion Criteria:

* None

Primary outcomes:
measure: Self-efficacy to cope with economic abuse
timeFrame: Baseline and 4-month follow-up
measure: Self-efficacy to use family planning in the face of reproductive coercion among women of reproductive age (15-49 years)
timeFrame: Baseline and 4-month follow-up
measure: Self-efficacy to seek formal intimate partner violence support services
timeFrame: Baseline and 4-month follow-up
measure: Self-efficacy to seek support from the group/group members if experiencing violence (economic abuse, reproductive coercion among women of reproductive age [15-49 years], intimate partner violence)
timeFrame: Baseline and 4-month follow-up
Secondary outcomes:
measure: Attitudes supportive of women's economic self-sufficiency
timeFrame: Baseline and 4-month follow-up
measure: Attitudes supportive of family planning use
timeFrame: Baseline and 4-month follow-up
measure: Attitudes not accepting of reproductive coercion
timeFrame: Baseline and 4-month follow-up
measure: Attitudes not accepting of intimate partner violence
timeFrame: Baseline and 4-month follow-up
measure: Awareness of intimate partner violence services
timeFrame: Baseline and 4-month follow-up
measure: Family planning knowledge
timeFrame: Baseline and 4-month follow-up
measure: Knowledge of financial resources
timeFrame: Baseline and 4-month follow-up
measure: Financial self-efficacy
timeFrame: Baseline and 4-month follow-up
measure: Self-efficacy to access family planning services among women of reproductive age (15-49 years)
timeFrame: Baseline and 4-month follow-up
measure: Self-efficacy to use a family planning method among women of reproductive age (15-49 years)
timeFrame: Baseline and 4-month follow-up
measure: Self-efficacy to support someone experiencing violence (economic abuse, reproductive coercion, intimate partner violence)
timeFrame: Baseline and 4-month follow-up
Other outcomes:
measure: Group norms supportive of women's economic self-sufficiency
timeFrame: Baseline and 4-month follow-up
measure: Group norms supportive of family planning use
timeFrame: Baseline and 4-month follow-up
measure: Group norms not accepting of reproductive coercion
timeFrame: Baseline and 4-month follow-up
measure: Group norms not accepting of intimate partner violence
timeFrame: Baseline and 4-month follow-up
Locations:
city: Eldoret
country: Kenya
facility: Community-based Women's Economic Empowerment Groups in Uasin Gishu County
Study officials:
affiliation: University of California, San Diego
name: Jay G Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References: