GBV Prevention, Mitigation, and Response in Colombia

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06312592
• Other study ID #: FWA00015367
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 253
• Est. completion date: September 1, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Decision Making
• Empowerment
• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
Colombia	Los Andes University	Bogotá

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Universidad de Los Andes

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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