N/A
N=253
GBV Prevention, Mitigation, and Response in Colombia
Refugee Self-reliance · Mental Health Issue · Empowerment · Gender Based Violence Knowledge and Perceived Risk · Decision Making
Bottom Line
View on ClinicalTrials.gov: NCT06312592 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Self-reliance Index From Baseline to Endline — -0.03; -0.21 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Entrepreneurship School with Gender Lens (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-reliance Index From Baseline to Endline |
-0.03; -0.21 | — |
| SECONDARY Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline |
-0.93; -1.49 | — |
| SECONDARY Change in Brief Scale of Resilient Strategies From Baseline to Endline |
1.10; 0.43 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT06312592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.