NCT02266108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 4, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

4.2 years

First QC Date

October 10, 2014

Results QC Date

October 25, 2018

Last Update Submit

October 15, 2019

Conditions

Keywords

Sexually Transmitted InfectionsFemale Sex Workers

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    12 months

  • Decreased Sexually Transmitted Infections

    decreased reported Sexually Transmitted Infections

    6 months

Study Arms (2)

ESTIMA intervention

EXPERIMENTAL

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

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.

Behavioral: ESTIMA Intervention

Interventions

This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico.

ESTIMA interventionWait-list control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not be a part of a recent behavioral intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Ninos De Baja California

Tijuana, Estado de Baja California, Mexico

Location

MeSH Terms

Conditions

Sexually Transmitted DiseasesAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHIV InfectionsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Elizabeth Reed, Associate Professor
Organization
UCSDMED

Study Officials

  • Elizabeth Reed, ScD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 16, 2014

Study Start

August 1, 2014

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 4, 2019

Results First Posted

November 4, 2019

Record last verified: 2019-10

Locations