- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266108
Economic and Social Empowerment To Increase Upwards Mobility Among Women (ESTIMA)
ESTIMA: Economic and Social Empowerment To Increase Upwards Mobility Among Women
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baja California
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Tijuana, Baja California, Mexico
- Los Ninos De Baja California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESTIMA intervention
This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up.
|
This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico.
|
Other: Wait-list control
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.
|
This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Decreased Economic Vulnerability
Time Frame: 12 months
|
Economic vulnerability was measured by asking women about several financial challenges creating urgency in their work.
We also measured income.
|
12 months
|
Number of Participants With Increased Collective Efficacy
Time Frame: 12 months
|
improved reported support from other women; increased sense of unity within group, increased sense of belonging
|
12 months
|
Decreased Sexually Transmitted Infections
Time Frame: 6 months
|
decreased reported Sexually Transmitted Infections
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth Reed, ScD, University of California, San Diego
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Sexually Transmitted Diseases
Other Study ID Numbers
- 140523
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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