Sexually Transmitted InfectionsESTIMANCT02266108
Economic and Social Empowerment To Increase Upwards Mobility Among Women
A study testing ESTIMA Intervention in people with Sexually Transmitted Infections and Human Immunodeficiency Virus, run by University of California, San Diego at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections, Human Immunodeficiency Virus
- What is being tested?
- ESTIMA Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2014to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not be a part of a recent behavioral intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ESTIMA: Economic and Social Empowerment To Increase Upwards Mobility Among Women
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.
Read the 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.
- Being tested
- ESTIMA Intervention
- Keywords
- Sexually Transmitted Infections, Female Sex Workers
- Medical subject headings
- Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTIMA InterventionBehavioural
This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico.
| Study group | Role | What they receive |
|---|---|---|
| ESTIMA intervention | Experimental | This group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up. Receives: Behavioral: ESTIMA Intervention |
| Wait-list control | Other | 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. Receives: Behavioral: ESTIMA Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Number of Participants With Increased Collective Efficacy
improved reported support from other women; increased sense of unity within group, increased sense of belonging
Measured: 12 months
Decreased Sexually Transmitted Infections
decreased reported Sexually Transmitted Infections
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study start1 Aug 2014
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexually Transmitted InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Reed, University of California, San Diego
- Investigators
- Elizabeth Reed, ScD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266108
- Sponsor's protocol ID
- 140523
- Acronym
- ESTIMA
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2014
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESTIMA: Economic and Social Empowerment To Increase Upwards Mobility Among Women
- ClinicalTrials.gov ID
- NCT02266108
- Acronym / sponsor ID
- ESTIMA / 140523
- Keywords
- Sexually Transmitted Infections, Female Sex Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESTIMA intervention | Experimental | Behavioral: ESTIMA InterventionThis group is randomized to receive the ESTIMA intervention and will be followed for 12 months for follow-up. |
| Wait-list control | Other | Behavioral: ESTIMA InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Not be a part of a recent behavioral intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESTIMA InterventionThis study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico. | Behavioural | ESTIMA intervention, Wait-list control |
Primary outcome
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.
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
Decreased Sexually Transmitted Infections
Time frame: 6 months
decreased reported Sexually Transmitted Infections
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sexually Transmitted Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Reed, ScD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESTIMA Intervention in people with Sexually Transmitted Infections and Human Immunodeficiency Virus, run by University of California, San Diego at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Decreased Economic Vulnerability (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.