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Economic and Social Empowerment To Increase Upwards Mobility Among Women (ESTIMA)

Primary Purpose

Sexually Transmitted Infections, Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
ESTIMA Intervention
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring Sexually Transmitted Infections, Female Sex Workers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Los Ninos De Baja California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ESTIMA intervention

Wait-list control

Arm Description

This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up.

This group will receive standard of care (education as well as referrals to testing and treatment). After 12 months of follow-up, this group will receive the ESTIMA intervention.

Outcomes

Primary Outcome Measures

Number of Participants With Decreased Economic Vulnerability
Economic vulnerability was measured by asking women about several financial challenges creating urgency in their work. We also measured income.
Number of Participants With Increased Collective Efficacy
improved reported support from other women; increased sense of unity within group, increased sense of belonging
Decreased Sexually Transmitted Infections
decreased reported Sexually Transmitted Infections

Secondary Outcome Measures

Full Information

First Posted
October 10, 2014
Last Updated
October 15, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02266108
Brief Title
Economic and Social Empowerment To Increase Upwards Mobility Among Women
Acronym
ESTIMA
Official Title
ESTIMA: Economic and Social Empowerment To Increase Upwards Mobility Among Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections, Human Immunodeficiency Virus
Keywords
Sexually Transmitted Infections, Female Sex Workers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESTIMA intervention
Arm Type
Experimental
Arm Description
This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up.
Arm Title
Wait-list control
Arm Type
Other
Arm Description
This group will receive standard of care (education as well as referrals to testing and treatment). After 12 months of follow-up, this group will receive the ESTIMA intervention.
Intervention Type
Behavioral
Intervention Name(s)
ESTIMA Intervention
Intervention Description
This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico.
Primary Outcome Measure Information:
Title
Number of Participants With Decreased Economic Vulnerability
Description
Economic vulnerability was measured by asking women about several financial challenges creating urgency in their work. We also measured income.
Time Frame
12 months
Title
Number of Participants With Increased Collective Efficacy
Description
improved reported support from other women; increased sense of unity within group, increased sense of belonging
Time Frame
12 months
Title
Decreased Sexually Transmitted Infections
Description
decreased reported Sexually Transmitted Infections
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Reed, ScD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Ninos De Baja California
City
Tijuana
State/Province
Baja California
Country
Mexico

12. IPD Sharing Statement

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