Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT06312592
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GBV Prevention, Mitigation, and Response in Colombia
Sponsor:
Organization:
Raw JSON
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As such, the study is a pilot RCT with baseline and endline data.'}}, 'adverseEventsModule': {'timeFrame': 'Eight months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': "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.\n\nThe ESGL also includes a mental health and psychosocial support module.", 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 0, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Self-reliance Index From Baseline to Endline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': "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.\n\nThe ESGL will also include a mental health and psychosocial support module."}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Past three months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample that was measured at both baseline and endline'}, {'type': 'SECONDARY', 'title': 'Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': "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.\n\nThe ESGL also includes a mental health and psychosocial support module."}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.93', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '5.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Past two weeks', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants measured at baseline and endline.'}, {'type': 'SECONDARY', 'title': 'Change in Brief Scale of Resilient Strategies From Baseline to Endline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': "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.\n\nThe ESGL also includes a mental health and psychosocial support module."}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last three months', 'description': 'The BriefScale of Resilient Strategies is a 4-item measure of resilience. 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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.\n\nThe ESGL also includes a mental health and psychosocial support module."}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'Of 286 individuals screened, 253 met inclusion criteria and were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': "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.\n\nThe ESGL also includes a mental health and psychosocial support module."}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.50', 'spread': '11.49', 'groupId': 'BG000'}, {'value': '39.04', 'spread': '12.12', 'groupId': 'BG001'}, {'value': '39.36', 'spread': '11.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Self-Reliance Index', 'classes': [{'categories': [{'measurements': [{'value': '3.27', 'spread': '0.56', 'groupId': 'BG000'}, {'value': '3.27', 'spread': '0.50', 'groupId': 'BG001'}, {'value': '3.27', 'spread': '0.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PHQ-9', 'classes': [{'categories': [{'measurements': [{'value': '7.66', 'spread': '5.25', 'groupId': 'BG000'}, {'value': '9.01', 'spread': '4.82', 'groupId': 'BG001'}, {'value': '8.08', 'spread': '5.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief Resilient Coping Scale', 'classes': [{'categories': [{'measurements': [{'value': '16.85', 'spread': '2.18', 'groupId': 'BG000'}, {'value': '16.85', 'spread': '1.41', 'groupId': 'BG001'}, {'value': '16.85', 'spread': '1.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Completed primary school', 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Household size', 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'spread': '1.61', 'groupId': 'BG000'}, {'value': '4.18', 'spread': '1.79', 'groupId': 'BG001'}, {'value': '4.09', 'spread': '1.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'people', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nationality', 'classes': [{'categories': [{'title': 'Colombian', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Venezuelan', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participant nationality. All participants are either Colombian or Venezuelan.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-27', 'size': 362786, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-30T09:39', 'hasProtocol': True}, {'date': '2024-04-30', 'size': 105203, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-30T09:41', 'hasProtocol': False}, {'date': '2024-02-27', 'size': 255505, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-08T15:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2024-02-29', 'resultsFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-15', 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Self-reliance Index From Baseline to Endline', 'timeFrame': 'Past three months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline', 'timeFrame': 'Past two weeks', 'description': '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.'}, {'measure': 'Change in Brief Scale of Resilient Strategies From Baseline to Endline', 'timeFrame': 'Last three months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refugee Self-reliance', 'Mental Health Issue', 'Empowerment', 'Gender Based Violence Knowledge and Perceived Risk', 'Decision Making']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Based on self identification', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman\n* At least 18 years of age\n* At risk of gender based violence (GBV) or ever experienced GBV\n* Have a migratory permit (for migrants/refugees)\n* Colombian or Venezuelan, living in Colombia for at least six months\n* Hold an entrepreneur profile registered with HIAS (the implementing partner).\n\nExclusion Criteria:\n\n* Man or does not self identify as a woman\n* Less than 18 years old\n* Not at risk of GBV and never experienced GBV\n* Does not have a migratory permit\n* Not Colombian or Venezuelan\n* Living in Colombia for less than six months\n* No entrepreneur profile registered with HIAS (the implementing partner).'}, 'identificationModule': {'nctId': 'NCT06312592', 'briefTitle': 'GBV Prevention, Mitigation, and Response in Colombia', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Owning Rights and Protection: GBV Prevention, Mitigation, and Response in Colombia', 'orgStudyIdInfo': {'id': 'FWA00015367'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': "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.", 'interventionNames': ['Behavioral: Entrepreneurship School with Gender Lens']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention'}], 'interventions': [{'name': 'Entrepreneurship School with Gender Lens', 'type': 'BEHAVIORAL', 'description': "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.\n\nThe ESGL will also include a mental health and psychosocial support module.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Los Andes University', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad de Los Andes', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lindsay Stark', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}