Refugee Self-relianceNCT06312592
GBV Prevention, Mitigation, and Response in Colombia
A study testing Entrepreneurship School with Gender Lens in people with Refugee Self-reliance and Mental Health Issue, run by Washington University School of Medicine at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Refugee Self-reliance, Mental Health Issue, Empowerment
- What is being tested?
- Entrepreneurship School with Gender Lens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteColombia
- Study dates
- 11 Mar 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Refugee Self-reliance, Mental Health Issue, Empowerment, Gender Based Violence Knowledge and Perceived Risk, Decision Making
- Being tested
- Entrepreneurship School with Gender Lens
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entrepreneurship School with Gender LensBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Entrepreneurship School with Gender Lens |
| Control group | No intervention | Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-reliance Index From Baseline to Endline
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.
Measured: Past three months
Secondary outcomes (2)
Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline
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.
Measured: Past two weeks
Change in Brief Scale of Resilient Strategies From Baseline to Endline
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.
Measured: Last three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start11 Mar 2024
- Primary completion30 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refugee Self-relianceStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de los Andes, Chile
- Responsible party
- Principal investigator, Lindsay Stark, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312592
- Sponsor's protocol ID
- FWA00015367
- Status last verified
- May 2025
- First submitted
- 29 Feb 2024
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Owning Rights and Protection: GBV Prevention, Mitigation, and Response in Colombia
- ClinicalTrials.gov ID
- NCT06312592
- Acronym / sponsor ID
- FWA00015367
- Conditions
- Refugee Self-reliance, Mental Health Issue, Empowerment, Gender Based Violence Knowledge and Perceived Risk, Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Universidad de los Andes, Chile
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Entrepreneurship School with Gender LensReceives 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. |
| Control group | No intervention | –Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entrepreneurship School with Gender LensThe 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. | Behavioural | Intervention group |
Primary outcome
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.
2 secondary outcomes
Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline
Time frame: Past two weeks
Change in Brief Scale of Resilient Strategies From Baseline to Endline
Time frame: Last three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entrepreneurship School with Gender Lens in people with Refugee Self-reliance and Mental Health Issue, run by Washington University School of Medicine at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-reliance Index From Baseline to Endline (time frame: Past three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.