GBV Prevention, Mitigation, and Response in Colombia

NCT06312592 | Completed Results

• 1 other identifier: FWA00015367
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

As of August 2021, Colombia hosts the vast majority of Venezuelan refugees and migrants (UNHCR, 2022). For vulnerable refugees and migrants in Colombia, and especially for women, gender-based violence (GBV) is present during transit and continues in their new homes where xenophobia, lack of accessible and adequate services, lack of safe economic opportunities, and lack of information on access to services, further increase risk. Lack of livelihood opportunities also affect vulnerable refugees and migrants, especially women, with barriers to employment including lack of information; precarious working conditions with lower payments and longer working days with increasing risks of labor exploitation; xenophobia and discrimination; limited access to formal labor markets; lack of access to financial services, among others. To address these issues, the investigators are conducting a pilot randomized-controlled trial (RCT) of HIAS' Entrepreneurship School with Gender Lens (ESGL), a methodology that targets GBV survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. The pilot RCT will be conducted within three cities in Colombia; approximately 80 eligible participants will be enrolled in each city and randomized to a treatment or control arm. Survey questionnaires will be administered to participants at baseline, eight months following baseline (endline), and 3-4 months after endline. Outcomes of interest include household self-reliance, mental health, empowerment, decision-making, and GBV risk and knowledge.

Conditions

Refugee Self-reliance; Mental Health Issue; Empowerment; Gender Based Violence Knowledge and Perceived Risk; Decision Making

Outcome Measures

Primary Outcomes (1)

• Change in Self-reliance Index From Baseline to Endline

  The Self-Reliance Index (SRI) is a measure of refugee self-reliance, created by the Refugee Self-Reliance Initiative. The final score is calculated using 12 domains of self-reliance, including the health-related domains of healthcare access and health status. SRI scores may assume a value from 1 to 5, with 5 indicating greater self-reliance.

  Past three months

Secondary Outcomes (2)

• Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline

  Past two weeks

• Change in Brief Scale of Resilient Strategies From Baseline to Endline

  Last three months

Study Arms (2)

Intervention group

EXPERIMENTAL

Receives the Entrepreneurship School with Gender Lens intervention. Participants receive a general training with six modules focused on business modeling and female empowerment for the participants. It is targeted for women who are forcibly displaced people, including refugees, and who are survivors or at risk of Sexual or Gender Based Violence. Each women entrepreneur, participates in individual mentoring sessions to build their business plan after the training and receives $800 start-up capital for their business plan. For at least a year, entrepreneurs will have a follow-up to promote their business scale up, including how to formalize their business in the market, how to define new strategies, and how to answer to the market's evolving requirements. Additionally, the participants receive an extensive training in gender aspects that have been identified as relevant to promote women's empowerment. The intervention also includes mental health content.

Behavioral: Entrepreneurship School with Gender Lens

Control group

NO INTERVENTION

Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention

Interventions

Entrepreneurship School with Gender Lens BEHAVIORAL

The Entrepreneurship School with Gender Lens (ESGL) is an approach that targets gender based violence survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. Participants will go through a general business curriculum, work on business plans and learn gender issues and ways to mitigate GBV risks. Upon training completion, participants are eligible to pitch their business idea to a panel of experts and receive $800 of seed capital. They will also receive follow-up business advisory support for at least six months, focusing on access to markets and finance and building support networks, in order to continue building self-reliance. The ESGL will also include a mental health and psychosocial support module.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on self identification
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman
• At least 18 years of age
• At risk of gender based violence (GBV) or ever experienced GBV
• Have a migratory permit (for migrants/refugees)
• Colombian or Venezuelan, living in Colombia for at least six months
• Hold an entrepreneur profile registered with HIAS (the implementing partner).

You may not qualify if:

• Man or does not self identify as a woman
• Less than 18 years old
• Not at risk of GBV and never experienced GBV
• Does not have a migratory permit
• Not Colombian or Venezuelan
• Living in Colombia for less than six months
• No entrepreneur profile registered with HIAS (the implementing partner).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Universidad de Los Andes: collaborator

Study Sites (1)

Los Andes University

Bogotá, Colombia

Location

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Limitations and Caveats

The study was originally designed to include a third round of data collection for March 2025. However, the study received a stop work order and termination from the funder in January 2025, preventing the last round of data collection from taking place. As such, the study is a pilot RCT with baseline and endline data.

Results Point of Contact

• Title: Dr. Lindsay Stark
• Organization: Washington University in St. Louis

lindsaystark@wustl.edu

314-935-4747

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: March 11, 2024
• Primary Completion: December 30, 2024
• Study Completion: April 1, 2025
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)