Clinical trial NCT06312592: GBV Prevention, Mitigation, and Response in Colombia
Official title: Owning Rights and Protection: GBV Prevention, Mitigation, and Response in Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refugee Self-reliance
Mental Health Issue
Empowerment
Gender Based Violence Knowledge and Perceived Risk
Decision Making
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Universidad de Los Andes
First posted: 2024-03-15
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Change in Self-reliance Index From Baseline to Endline
timeFrame: Past three months
Secondary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline
timeFrame: Past two weeks
measure: Change in Brief Scale of Resilient Strategies From Baseline to Endline
timeFrame: Last three months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Los Andes University
Study officials:
References: