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临床试验/NCT06312592
NCT06312592已完成不适用

Owning Rights and Protection: GBV Prevention, Mitigation, and Response in Colombia

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2024年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
253
试验地点
1
主要终点
Change in Self-reliance Index From Baseline to Endline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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).

结局指标

主要结局

Change in Self-reliance Index From Baseline to Endline

时间窗: 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.

次要结局

  • Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline(Past two weeks)
  • Change in Brief Scale of Resilient Strategies From Baseline to Endline(Last three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindsay Stark

Professor

Washington University School of Medicine

研究点 (1)

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