Clinical trial NCT01465607: Implementation of an Efficacious Intervention for High Risk Women in Mexico
Official title: Implementation of an Efficacious Intervention for High Risk Women in Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Syphilis
Gonorrhea
Chlamydia
Keywords: Condom use
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-11-06
Enrollment: 1228
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in HIV and STI incidence relative to control group
timeFrame: 6 months
measure: Reduction in number of unprotected sex acts relative to control group
timeFrame: 6 months
Secondary outcomes:
measure: Fidelity to Mujer Segura intervention model
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro de Servicios Medicos (CSM) Revolucion
state: D.f.
city: Guadalajara
country: Mexico
facility: CSM Guadalajara
state: Jalisco
city: Naranjos
country: Mexico
facility: CSM Naranjos
state: Veracruz
city: Veracruz
country: Mexico
facility: CSM Veracruz
Study officials:
affiliation: University of California, San Diego
name: Thomas L Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Patterson 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.