Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers

Phase 2

Completed

• Conditions: HIV Infections; Sexually Transmitted Diseases
• Interventions: Behavioral: Share Safer Sex program; Behavioral: Standard didactic safer-sex counseling program

• Registration Number: NCT00338845
• Lead Sponsor: University of California, San Diego

Brief Summary

This study will evaluate the effectiveness of the Share Safer Sex Program in reducing sexual risk behaviors among female sex workers in four Mexican cities close to the U.S. border.

Detailed Description

Mexican female sex workers (FSWs) represent a large portion of the reported cases of AIDS and other sexually transmitted diseases (STDs) in Mexico. Despite the imbalance in the distribution of reported cases, there have been few efforts to change high-risk sexual behaviors in this population. There has been a dramatic increase in HIV and other STDs over the past decade, especially in Mexican cities along the United States border. Border cities often have a thriving sex trade industry, and some are considered "sexual tourist" destinations. FSWs in these border cities, however, often do not know how to practice safe sex. A previous study showed that a culturally sensitive risk reduction counseling program was effective in reducing sexual risk behavior in FSWs in Tijuana, Mexico. It may therefore be possible to implement the same program, with similar efficacy, in other Mexican cities near the U.S. border. This study will evaluate the effectiveness of the Share Safer Sex Program versus a standard counseling program in reducing sexual risk behaviors among FSWs in the Mexican cities of Tijuana, Ciudad Juarez, Nuevo Laredo, and Matamoros.

Participants in this open label study will be randomly assigned to either the Share Safer Sex Program or a standard counseling program. Both programs will last for 6 months and will consist of a single counseling session lasting between 35 and 40 minutes. All participants will undergo blood collection and a gynecological exam upon study entry and 6 months later. The standard counseling program will be based on a sexual risk reduction counseling program developed by the Centers for Disease Control and Prevention, and will focus on personal risk assessment and strategies for risk reduction. Additionally, it will incorporate risk reduction materials provided by CENSIDA, Mexico's National Center for AIDS Studies. The Share Safer Sex Program will be tailored to the needs, values, beliefs, and behaviors of the participants, and will take into account gender and cultural differences. Counselors will work with participants to increase personal awareness of their current unsafe behaviors and the associated risks, help them understand their motivation to change, and increase their knowledge about how to practice safe sex. Demonstrations and practice exercises will be used to improve participants' attitudes about, as well as intentions to practice, condom use. The counseling session will include the following activities: assessing readiness for change; building motivation for change; and performing exercises in decisional balance, identification of problem and problem-solving, and knowledge and skill-building. Outcomes for both treatment groups will be assessed after 6 months. Participants in the standard counseling program will be offered an opportunity to participate in the Share Safer Sex Program upon completion of the study.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2006-06-16
• Study First Submitted QC: 2006-06-16
• Study First Posted: 2006-06-20
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1800

Inclusion Criteria

• Reports having had unprotected vaginal, oral, or anal sex at least once within 2 weeks prior to study entry

Exclusion Criteria

• Consistent use of condoms or dental dams for vaginal, oral, and anal sex with all clients within 2 weeks prior to study entry
• Duration of employment as an FSW is less than 2 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Share Safer Sex program	Participants will receive the Share Safer Sex counseling program
2	Standard didactic safer-sex counseling program	Participants will receive a standard didactic safer-sex counseling session

Primary Outcome Measures

Name	Time	Method
Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner	Measured at Month 6 post-treatment

Secondary Outcome Measures

Name	Time	Method
STD incidence	Measured at Month 6 post-treatment
Knowledge, self-efficacy, and positive outcome expectancies re: condom use	Measured at Month 6 post-treatment

Trial Locations

Locations (1)

Study outreach clinic; 🇲🇽 Tijuana, B.c., Mexico