protocolSection identificationModule nctId: NCT06312592, orgStudyIdInfo id: FWA00015367, briefTitle: GBV Prevention, Mitigation, and Response in Colombia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: Universidad de Los Andes, 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., conditionsModule conditions: Refugee Self-reliance, conditions: Mental Health Issue, conditions: Empowerment, conditions: Gender Based Violence Knowledge and Perceived Risk, conditions: Decision Making, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 253, type: ACTUAL, armsInterventionsModule interventions name: Entrepreneurship School with Gender Lens, outcomesModule primaryOutcomes measure: Self-Reliance Index, secondaryOutcomes measure: Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Brief Scale of Resilient Strategies, secondaryOutcomes measure: Multidimensional Women's Empowerment Index, secondaryOutcomes measure: GBV perceived risk, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Los Andes University, city: Bogotá, country: Colombia, geoPoint lat: 4.60971, lon: -74.08175, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-27, uploadDate: 2024-03-08T15:46, filename: ICF_000.pdf, size: 255505, hasResults: False