Trial Outcomes & Findings for GBV Prevention, Mitigation, and Response in Colombia (NCT NCT06312592)
NCT ID: NCT06312592
Last Updated: 2025-05-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
Past three months
Results posted on
2025-05-16
Participant Flow
Participants were identified by HIAS through existing databases, external referrals from other organizations in the field and open calls. Potential participants were then prescreened, screened, and enrolled in the study based on a set of criteria from March 11th to 21st, 2024.
Of 286 individuals screened, 253 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Intervention Group
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 also includes a mental health and psychosocial support module.
|
Control Group
Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
78
|
|
Overall Study
COMPLETED
|
146
|
65
|
|
Overall Study
NOT COMPLETED
|
29
|
13
|
Reasons for withdrawal
| Measure |
Intervention Group
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 also includes a mental health and psychosocial support module.
|
Control Group
Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
29
|
13
|
Baseline Characteristics
GBV Prevention, Mitigation, and Response in Colombia
Baseline characteristics by cohort
| Measure |
Intervention Group
n=175 Participants
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 also includes a mental health and psychosocial support module.
|
Control Group
n=78 Participants
Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
169 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
39.50 years
STANDARD_DEVIATION 11.49 • n=5 Participants
|
39.04 years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
39.36 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
175 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
175 participants
n=5 Participants
|
78 participants
n=7 Participants
|
253 participants
n=5 Participants
|
|
Self-Reliance Index
|
3.27 units on a scale
STANDARD_DEVIATION 0.56 • n=5 Participants
|
3.27 units on a scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
3.27 units on a scale
STANDARD_DEVIATION 0.54 • n=5 Participants
|
|
PHQ-9
|
7.66 units on a scale
STANDARD_DEVIATION 5.25 • n=5 Participants
|
9.01 units on a scale
STANDARD_DEVIATION 4.82 • n=7 Participants
|
8.08 units on a scale
STANDARD_DEVIATION 5.15 • n=5 Participants
|
|
Brief Resilient Coping Scale
|
16.85 units on a scale
STANDARD_DEVIATION 2.18 • n=5 Participants
|
16.85 units on a scale
STANDARD_DEVIATION 1.41 • n=7 Participants
|
16.85 units on a scale
STANDARD_DEVIATION 1.97 • n=5 Participants
|
|
Completed primary school
|
123 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Household size
|
4.05 people
STANDARD_DEVIATION 1.61 • n=5 Participants
|
4.18 people
STANDARD_DEVIATION 1.79 • n=7 Participants
|
4.09 people
STANDARD_DEVIATION 1.66 • n=5 Participants
|
|
Nationality
Colombian
|
51 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Nationality
Venezuelan
|
124 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Past three monthsPopulation: The sample that was measured at both baseline and 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.
Outcome measures
| Measure |
Intervention Group
n=146 Participants
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.
|
Control Group
n=65 Participants
Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention
|
|---|---|---|
|
Change in Self-reliance Index From Baseline to Endline
|
-0.03 score on a scale
Standard Deviation 0.64
|
-0.21 score on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Past two weeksPopulation: Participants measured at baseline and 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.
Outcome measures
| Measure |
Intervention Group
n=146 Participants
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.
|
Control Group
n=65 Participants
Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention
|
|---|---|---|
|
Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline
|
-0.93 score on a scale
Standard Deviation 5.21
|
-1.49 score on a scale
Standard Deviation 5.71
|
SECONDARY outcome
Timeframe: Last three monthsPopulation: Participants who were measured at baseline and 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.
Outcome measures
| Measure |
Intervention Group
n=146 Participants
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.
|
Control Group
n=65 Participants
Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention
|
|---|---|---|
|
Change in Brief Scale of Resilient Strategies From Baseline to Endline
|
1.10 score on a scale
Standard Deviation 3.35
|
0.43 score on a scale
Standard Deviation 3.66
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place