- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06414070
Developing and Testing the Jenga Dada Intervention in Kenya
Jenga Dada: A Group-based Intervention to Prevent Partner Violence and Unintended Pregnancy Among Women in Kenya
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eldoret, Kenya
- Community-based Women's Economic Empowerment Groups in Uasin Gishu County
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Waitlist Control
Standard women's economic empowerment group programming
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Experimental: Jenga Dada
Jenga Dada programming in women's economic empowerment group meetings
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Jenga Dada aims to empower women participating in community-based economic groups by training them to recognize inequality, challenge it, and work toward positive changes in their lives related to finances, health, and relationships and increase social support on these issues within the groups.
Jenga Dada is expected to include eight modules: 1) overview of the intervention, 2) gender roles, 3) economic control and abuse, 4) intimate partner violence (IPV), 5) reproductive coercion (RC), 6) family planning (FP), 7) financial literacy, and 8) life goals.
The Jenga Dada intervention is group discussion-based and draws on two effective interventions: ARCHES (a facility-based contraceptive counseling intervention providing support for RC and IPV) and Girls Invest (a mobile health application with integrated modules on gender, IPV, and financial literacy).
The intervention will be facilitated by a local NGO in partnership with group leaders.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy to cope with economic abuse
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 6-18, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Self-efficacy to use family planning in the face of reproductive coercion among women of reproductive age (15-49 years)
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 3-9, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Self-efficacy to seek formal intimate partner violence support services
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 1-3, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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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)
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 3-9 among women of reproductive age [15-49 years]; range: 2-6 for women above reproductive age [50+ years], higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Financial self-efficacy
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 4-12, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Attitudes supportive of women's economic self-sufficiency
Time Frame: Baseline and 4-month follow-up
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Change in mean attitude score (range: 5-25, higher = more supportive attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Attitudes not accepting of reproductive coercion
Time Frame: Baseline and 4-month follow-up
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Change in mean attitude score (range: 6-30, higher=attitudes less accepting of reproductive coercion/improved attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Attitudes not accepting of intimate partner violence
Time Frame: Baseline and 4-month follow-up
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Change in mean attitude score (range: 10-50, higher = attitudes less accepting of intimate partner violence/improved attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Awareness of intimate partner violence services
Time Frame: Baseline and 4-month follow-up
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Change in prevalence of awareness of intimate partner violence services between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Attitudes supportive of family planning use
Time Frame: Baseline and 4-month follow-up
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Change in mean attitude score (range: 7-35, higher = more supportive attitudes) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
|
Baseline and 4-month follow-up
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Family planning knowledge
Time Frame: Baseline and 4-month follow-up
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Change in mean knowledge score (range: 0-8, higher = more accurate knowledge) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Knowledge of financial resources
Time Frame: Baseline and 4-month follow-up
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Change in prevalence of knowledge of financial resources between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Self-efficacy to access family planning services among women of reproductive age (15-49 years)
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 4-12, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Self-efficacy to use a family planning method among women of reproductive age (15-49 years)
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 4-12, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Self-efficacy to support someone experiencing violence (economic abuse, reproductive coercion, intimate partner violence)
Time Frame: Baseline and 4-month follow-up
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Change in mean self-efficacy score (range: 6-18, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Group norms supportive of women's economic self-sufficiency
Time Frame: Baseline and 4-month follow-up
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Change in mean group norm score based off individual attitudes scales aggregated at group (i.e.
cluster) level (range: 5-25, higher = more supportive norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
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Baseline and 4-month follow-up
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Group norms not accepting of reproductive coercion
Time Frame: Baseline and 4-month follow-up
|
Change in mean group norm score based off individual attitudes scales aggregated at group (i.e.
cluster) level (range: 6-30, higher = norms less accepting of reproductive coercion/improved norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
|
Baseline and 4-month follow-up
|
|
Group norms not accepting of intimate partner violence
Time Frame: Baseline and 4-month follow-up
|
Change in mean group norm score based off individual attitudes scales aggregated at group (i.e.
cluster) level (range: 10-50, higher = norms less accepting of intimate partner violence/improved norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
|
Baseline and 4-month follow-up
|
|
Group norms supportive of family planning use
Time Frame: Baseline and 4-month follow-up
|
Change in mean group norm score based off individual attitudes scales aggregated at group (i.e.
cluster) level (range: 7-35, higher = more supportive norms) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)
|
Baseline and 4-month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jay G Silverman, PhD, University of California, San Diego
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 800987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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