GBV Prevention, Mitigation, and Response in Colombia

Owning Rights and Protection: GBV Prevention, Mitigation, and Response in Colombia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Decision Making; Mental Health Issue; Empowerment; Refugee Self-reliance; Gender Based Violence Knowledge and Perceived Risk
• Intervention / Treatment: Behavioral: Entrepreneurship School with Gender Lens

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • Los Andes University
    • Contact: Arturo Harker Roa, PhD
    • Principal Investigator: Arturo Harker Roa, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.
No Intervention: Control group; Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reliance Index	The 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	9-item measure of depression. The score may assume a value from 0 to 27, with higher scores signaling greater depressive symptomology.	Past two weks
Brief Scale of Resilient Strategies	4-item measure of resilience. The score may assume a value from 4 to 20, with higher scores signaling greater resilience.	Last three months
Multidimensional Women's Empowerment Index	Assesses women's resources, domestic decision making, decision making on personal matters, and achievements. Items will be assessed separately.	Last 3 months
GBV perceived risk	Three questions measuring self-reported perceptions of feeling supported by the community, feeling useful, and feeling controlled by one or more people. Items will be assessed separately.	Last 3 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Universidad de Los Andes

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FWA00015367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No