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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas L. Patterson, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00338845
First received: June 16, 2006
Last updated: April 9, 2013
Last verified: April 2013

June 16, 2006
April 9, 2013
December 2003
November 2008   (final data collection date for primary outcome measure)
Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner [ Time Frame: Measured at Month 6 post-treatment ] [ Designated as safety issue: Yes ]
  • Measured 6 months post-intervention: Frequency of unprotected vaginal, oral, and anal sex with clients and spouse or steady partner
  • Protected sex ratio
  • Number of clients
  • Number and type of other sex partners (non-clients)
  • Number of partners who inject drugs
  • Number and type of STDs
  • Incidence of HIV/AIDS
  • Condom use
Complete list of historical versions of study NCT00338845 on ClinicalTrials.gov Archive Site
  • STD incidence [ Time Frame: Measured at Month 6 post-treatment ] [ Designated as safety issue: Yes ]
  • Knowledge, self-efficacy, and positive outcome expectancies re: condom use [ Time Frame: Measured at Month 6 post-treatment ] [ Designated as safety issue: No ]
  • Measured 6 months post-intervention: Mechanisms of change variables
  • Contextual variables
  • Social factors
  • Intrapersonal factors
Not Provided
Not Provided
 
Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers
Safer Sex Intervention for At-risk Women in Mexico

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Sexually Transmitted Diseases
  • Behavioral: Share Safer Sex program
    The Share Safer Sex intervention will consist of a single, 30 to 40 minute, one-on-one counseling session designed to increase personal awareness of the participant's current unsafe behaviors and the associated risks, help her understand her motivation to change, and increase her 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.
  • Behavioral: Standard didactic safer-sex counseling program
    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.
  • Experimental: 1
    Participants will receive the Share Safer Sex counseling program
    Intervention: Behavioral: Share Safer Sex program
  • Active Comparator: 2
    Participants will receive a standard didactic safer-sex counseling session
    Intervention: Behavioral: Standard didactic safer-sex counseling program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00338845
R01 MH065849, R01MH065849, DAHBR 9A-ASI
Not Provided
Thomas L. Patterson, University of California, San Diego
University of California, San Diego
National Institute of Mental Health (NIMH)
Principal Investigator: Thomas L. Patterson, PhD Dept. of Psychiatry, University of California, San Diego
University of California, San Diego
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP