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OpenTrials
Completed

NCT Number: NCT06312592

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Los Andes University

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Change in Self-reliance Index From Baseline to Endline

    Time frame: Past three months

    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.

Secondary outcomes

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

    Time frame: Past two weeks

    The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression. The score may assume a value from 0 to 27, with higher scores signaling greater depressive symptomology.

  2. Change in Brief Scale of Resilient Strategies From Baseline to Endline

    Time frame: Last three months

    The BriefScale of Resilient Strategies is a 4-item measure of resilience. The score may assume a value from 4 to 20, with higher scores signaling greater resilience.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Universidad de Los Andes

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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