Implementation of an Efficacious Intervention for High Risk Women in Mexico
1 other identifier
interventional
1,228
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Nov 2011
Typical duration for not_applicable hiv
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 2, 2011
CompletedFirst Posted
Study publicly available on registry
November 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 27, 2015
May 1, 2015
3.4 years
November 2, 2011
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction in HIV and STI incidence relative to control group
Female 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).
6 months
Reduction in number of unprotected sex acts relative to control group
Female 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).
6 months
Secondary Outcomes (1)
Fidelity to Mujer Segura intervention model
6 months
Study Arms (2)
Theory-based counseling (Mujer Segura)
EXPERIMENTALWill consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
CENSIDA counseling program (didactic)
ACTIVE COMPARATORWill consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
Interventions
Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous positive HIV test result
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centro de Servicios Medicos (CSM) Revolucion
Mexico City, D.f., 06080, Mexico
CSM Guadalajara
Guadalajara, Jalisco, 44270, Mexico
CSM Naranjos
Naranjos, Veracruz, 92300, Mexico
CSM Veracruz
Veracruz, Veracruz, 91910, Mexico
Related Publications (2)
Pitpitan EV, Semple SJ, Aarons GA, Palinkas LA, Chavarin CV, Mendoza DV, Magis-Rodriguez C, Staines H, Patterson TL. Factors associated with program effectiveness in the implementation of a sexual risk reduction intervention for female sex workers across Mexico: Results from a randomized trial. PLoS One. 2018 Sep 11;13(9):e0201954. doi: 10.1371/journal.pone.0201954. eCollection 2018.
PMID: 30204761DERIVEDPatterson TL, Semple SJ, Chavarin CV, Mendoza DV, Santos LE, Chaffin M, Palinkas LA, Strathdee SA, Aarons GA. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors. Implement Sci. 2012 Oct 29;7:105. doi: 10.1186/1748-5908-7-105.
PMID: 23107285DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas L Patterson, Ph.D.
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 2, 2011
First Posted
November 7, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05