## Protocol Section
### Identification Module
**NCT ID:** NCT06414070

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 800987
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Diego
### Status Module
#### Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Population Council Kenya

**Class:** UNKNOWN

**Name:** Women's Empowerment Link

**Class:** OTHER

**Name:** San Diego State University

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Diego

#### Responsible Party

**Investigator Affiliation:** University of California, San Diego

**Investigator Full Name:** Jay G. Silverman, PhD

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 our 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, we are adapting content from the ARCHES intervention along with Girls Invest, an economic empowerment intervention implemented in the US and Nigeria, 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: In this pilot trial, we will test the hypothesis that women participating in Jenga Dada will report improved proximal outcomes regarding a) financial self-efficacy, b) 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), c) reproductive health (self-efficacy to use contraceptives, including in the face of RC), and d) self-efficacy to seek support from women's economic group members and to support other members experiencing violence. 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 IPV, 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). We will also collect and analyze process data and post-program qualitative data among participants and implementers to evaluate the feasibility and acceptability of the program.

### Conditions Module

**Conditions:**

- Reproductive Coercion

- Intimate Partner Violence

- Economic Abuse

**Keywords:**

- Reproductive coercion

- Intimate partner violence

- Contraceptive Usage

- Economic Abuse

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Cluster-randomized controlled trial; stratified randomization based on urban/rural location

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 280

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Jenga Dada programming in women's economic empowerment group meetings

**Intervention Names:**

- Behavioral: Jenga Dada

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard women's economic empowerment group programming

**Label:** Waitlist Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** 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.

**Name:** Jenga Dada

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Financial self-efficacy

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Self-efficacy to cope with economic abuse

**Time Frame:** Baseline and 4-month follow-up

**Description:** Change in mean self-efficacy score (range: 11-33, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)

**Measure:** Self-efficacy to use family planning among women of reproductive age (15-49 years)

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** 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

**Description:** 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)

**Measure:** Self-efficacy to seek support from the group/group members for economic abuse

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Self-efficacy to seek support from the group/group members for reproductive coercion among women of reproductive age (15-49 years)

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Self-efficacy to seek support from the group/group members for intimate partner violence

**Time Frame:** Baseline and 4-month follow-up

**Description:** Change in mean self-efficacy score (range: 2-6, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)

**Measure:** Self-efficacy to support someone experiencing economic abuse

**Time Frame:** Baseline and 4-month follow-up

**Description:** Change in mean self-efficacy score (range: 2-6, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)

**Measure:** Self-efficacy to support someone experiencing reproductive coercion

**Time Frame:** Baseline and 4-month follow-up

**Description:** Change in mean self-efficacy score (range: 2-6, higher=higher self-efficacy) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)

**Measure:** Self-efficacy to support someone experiencing intimate partner violence

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Self-efficacy to seek formal intimate partner violence support services

**Time Frame:** Baseline and 4-month follow-up

#### Secondary Outcomes

**Description:** 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)

**Measure:** Attitudes supportive of women's economic self-sufficiency

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Attitudes supportive of family planning use

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Attitudes not accepting of reproductive coercion

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Attitudes not accepting of intimate partner violence

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Group norms supportive of women's economic self-sufficiency

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Group norms supportive of family planning use

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Group norms not accepting of reproductive coercion

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Group norms not accepting of intimate partner violence

**Time Frame:** Baseline and 4-month follow-up

**Description:** 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)

**Measure:** Awareness of intimate partner violence services

**Time Frame:** Baseline and 4-month follow-up

**Description:** Change in mean knowledge score (range: 0-10, higher = more accurate knowledge) between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)

**Measure:** Family planning knowledge

**Time Frame:** Baseline and 4-month follow-up

**Description:** Change in prevalence of knowledge of financial literacy resources between baseline and 4-month follow-up in intervention compared to control group (difference-in differences)

**Measure:** Knowledge of financial literacy resources

**Time Frame:** Baseline and 4-month follow-up

### Eligibility Module

**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

**Gender Based:** True

**Gender Description:** Self-report biologically female

**Minimum Age:** 15 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eepearson@health.ucsd.edu

**Name:** Erin Pearson, PhD MPH

**Phone:** 12546246937

**Role:** CONTACT

**Contact 2:**

**Email:** juysal@ucsd.edu

**Name:** Jasmine Uysal, MPH

**Phone:** 14259850772

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Diego

**Name:** Jay G Silverman, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Open access

**Description:** Will share de-identified quantitative participant data analysis sets to the Dryad public data repository upon publication of findings

**Info Types:**

- STUDY_PROTOCOL

- ICF

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** Upon publication of findings

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
