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| Name | Class |
|---|---|
| Universidad de Los Andes | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | No Intervention | Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Past three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Past two weeks |
| Change in Brief Scale of Resilient Strategies From Baseline to Endline |
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Inclusion Criteria:
Exclusion Criteria:
Based on self identification
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Andes University | Bogotá | Colombia |
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Of 286 individuals screened, 253 met inclusion criteria and were randomized to treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group | Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The sample that was measured at both baseline and endline | Posted | Mean | Standard Deviation | score on a scale | Past three months |
|
Eight months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study was originally designed to include a third round of data collection for March 2025. However, the study received a stop work order and termination from the funder in January 2025, preventing the last round of data collection from taking place. As such, the study is a pilot RCT with baseline and endline data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lindsay Stark | Washington University in St. Louis | 314-935-4747 | lindsaystark@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2024 | Apr 30, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2024 | Apr 30, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2024 | Mar 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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|
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. |
| Last three months |
| BG001 | Control Group | Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Self-Reliance Index | Mean | Standard Deviation | units on a scale |
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| PHQ-9 | Mean | Standard Deviation | units on a scale |
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| Brief Resilient Coping Scale | Mean | Standard Deviation | units on a scale |
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| Completed primary school | Count of Participants | Participants |
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| Household size | Mean | Standard Deviation | people |
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| Nationality | Participant nationality. All participants are either Colombian or Venezuelan. | Count of Participants | Participants |
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| OG001 | Control Group | Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention |
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| Secondary | 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. | Participants measured at baseline and endline. | Posted | Mean | Standard Deviation | score on a scale | Past two weeks |
|
|
|
| Secondary | 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. | Participants who were measured at baseline and endline | Posted | Mean | Standard Deviation | score on a scale | Last three months |
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|
| 0 |
| 175 |
| 0 |
| 175 |
| 0 |
| 175 |
| EG001 | Control Group | Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention | 0 | 78 | 0 | 78 | 0 | 78 |
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