Clinical trial NCT02266108: Economic and Social Empowerment To Increase Upwards Mobility Among Women
Official title: ESTIMA: Economic and Social Empowerment To Increase Upwards Mobility Among Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Human Immunodeficiency Virus
Keywords: Sexually Transmitted Infections
Female Sex Workers
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Not be a part of a recent behavioral intervention.

Primary outcomes:
measure: Number of Participants With Decreased Economic Vulnerability
timeFrame: 12 months
measure: Number of Participants With Increased Collective Efficacy
timeFrame: 12 months
measure: Decreased Sexually Transmitted Infections
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Los Ninos De Baja California
state: Baja California
Study officials:
affiliation: University of California, San Diego
name: Elizabeth Reed, ScD
role: PRINCIPAL_INVESTIGATOR
References: