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Implementation of an Efficacious Intervention for High Risk Women in Mexico

Implementation of an Efficacious Intervention for High Risk Women in Mexico

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01465607
Enrollment
1228
Registered
2011-11-07
Start date
2011-11-30
Completion date
2015-04-30
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia, Gonorrhea, HIV, Syphilis

Keywords

Condom use

Brief summary

This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs). Taking a brief, single-session counseling program (called Mujer Segura) that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness. Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.

Interventions

BEHAVIORALMujer Segura

Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).

BEHAVIORALCENSIDA counseling program

Didactic HIV and STI counseling involving some personal risk assessment and presenting appropriate information on methods of transmission and for avoiding or reducing the risk of infection. Based on a counseling manual disseminated by CENSIDA, Mexico's federal HIV-AIDS prevention agency.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* At least 18 years of age * Self-identify as female sex worker * Exchanged sex for money, drugs, shelter, or other benefit in last 2 months * Had unprotected anal or vaginal sex with male client at least once in last 2 months * Agree to be tested for HIV & STIs at baseline and 6-month follow-u0

Exclusion criteria

* Previous positive HIV test result

Design outcomes

Primary

MeasureTime frameDescription
Reduction in HIV and STI incidence relative to control group6 monthsFemale sex worker (FSW) participants will be tested at baseline and 6-month follow-up for HIV, syphilis, gonorrhea, and Chlamydia. Incidence rates for all infections at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
Reduction in number of unprotected sex acts relative to control group6 monthsFemale sex worker (FSW) participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with male clients. Changes in frequency at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).

Secondary

MeasureTime frameDescription
Fidelity to Mujer Segura intervention model6 monthsCounselors at each CBO will be assessed for their fidelity to the intervention protocol and assigned a numerical score. This number will be used to determine possible correlations between levels of fidelity and the efficacy of the Mujer Segura intervention at each clinic.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026