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临床试验/NCT02266108
NCT02266108已完成不适用

ESTIMA: Economic and Social Empowerment To Increase Upwards Mobility Among Women

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2014年8月1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
151
试验地点
1
主要终点
Number of Participants With Increased Collective Efficacy

研究概览

简要总结

The proposed research aims to pilot a multi-strategy structural intervention combining community mobilization to promote gender equity alongside an economic intervention (microfinance and business training) in order to reduce gender-based violence and HIV risk among female sex workers (FSW) in Tijuana, Mexico. The program will be called ESTIMA: "Economic and Social Empowerment To Increase Upwards Mobility Among Women." The evaluation will employ a randomized controlled design, recruiting FSW (n=120, 60 in each arm) who will be randomized to: 1) ESTIMA (gender equity/community mobilization program and economic intervention) or 2) a wait-list control group. For this preliminary work, at 12 months follow-up, we hypothesize that compared to control participants, intervention participants will have: 1) significantly greater economic security (e.g. decreased debt, increased income, decreased number of sex trades) and 2) significantly greater perceived collective power (i.e. collective efficacy) to address gendered power imbalances within social structures and the community. The long-term goal of this program, upon future refinement and large scale implementation, is to reduce HIV risk behaviors, STI/HIV, GBV, and ultimately, alleviate a multitude of health burdens among women. Furthermore, we expect that such work will highlight the need for HIV prevention initiatives in Mexico, and elsewhere, to more broadly consider women's 'life contexts' - addressing economic and social burdens in women's lives, to reduce the burden of poverty, gender, and HIV, as well as the intersection of these among women.

详细描述

The ESTIMA program will consist of the 1) Via microfinance program, which includes providing women with monetary loans as a group (approximately 10 women, with repayment as a group) and training them to initiate a business or other investment endeavor, and 2) gender equity community mobilization, which involves initiating groups of women (i.e. collectives) and engaging in social action within the community, with a focus on addressing issues relevant to gender inequities and women's economic mobility and power (such as client or police violence/harassment). Like the IMAGE program in South Africa, community mobilization will be incorporated into the Via microfinance trainings.

Priorities of mobilization efforts will be identified by the ESTIMA collectives, and facilitated by the election of collective leaders. As part of the microfinance efforts, women will be provided with a loan of up to $200 each and will support each other by agreeing to all be responsible to repay the loan as a group. While the amount is small, women can take out more money with subsequent loans to help them support the business.

The outcome evaluation of ESTIMA will employ a randomized controlled design. From the parent study (Dr. Brouwer, PI;R01 DA028692), we will recruit at least 120 participants in expectation to afford a final sample size of at least 48 in each group (using a conservative estimate of 80% retention). Eligible and willing participants will be randomized to treatment assignment (ESTIMA or wait-list control group) using a randomizer software package, after baseline data collection for the proposed research. The wait-list control group will be provided with referrals to local FSW support organizations, as the standard of care, and will receive ESTIMA subsequent to the 12 month follow-up data collection. ESTIMA will involve groups of approximately 10 women each; groups will initiate once sufficient numbers are enrolled (i.e. groups will be staggered in initiation of the ESTIMA program). Data collection will include a behavioral survey as well as HIV/STI testing.

This combined program addresses economic vulnerability while also supporting women via community mobilization to address challenging social conditions at work, in the community, and at home. This work affords an opportunity to evaluate the efficacy of a microfinance-based initiative to improve health outcomes among an economically vulnerable population of women, many who have been trafficked into sex work, and who face dire economic circumstances to support their families and children. The randomized controlled evaluation design will be among the first implemented among sex workers and among the few implemented globally to evaluate a microfinance-based program in terms of improving health outcomes. Such a robust design will be key to providing evidence needed regarding the efficacy of the ESTIMA program, and implications of the utility of microfinance as a means of HIV prevention among this population.

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
Single (Participant)

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

  • Biologically female,
  • At least 18 years old,
  • Ability to Speak English or Spanish
  • Report having exchanged sex for money, goods, shelter or drugs within the last month,
  • Live in Tijuana or its suburbs and have no plans to permanently move over the next 18 months
  • Willing and able to provide informed consent
  • Agree to receive antibiotic treatment for Chlamydia, gonorrhea and syphilis if they test positive

排除标准

  • Not be a part of a recent behavioral intervention.

结局指标

主要结局

Number of Participants With Increased Collective Efficacy

时间窗: 12 months

improved reported support from other women; increased sense of unity within group, increased sense of belonging

Decreased Sexually Transmitted Infections

时间窗: 6 months

decreased reported Sexually Transmitted Infections

Number of Participants With Decreased Economic Vulnerability

时间窗: 12 months

Economic vulnerability was measured by asking women about several financial challenges creating urgency in their work. We also measured income.

次要结局

未报告次要终点

研究者

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

Elizabeth Reed

Associate Professor

University of California, San Diego

研究点 (1)

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