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Share Safer Sex Counseling Program for Changing Sexual Risk Behaviors in Mexican Female Sex Workers
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), February 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00338845
  Purpose

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.


Condition Intervention Phase
HIV Infections
Sexually Transmitted Diseases
Behavioral: Share Safer Sex program
Behavioral: Standard didactic safer-sex counseling program
Phase II

MedlinePlus related topics: AIDS Sexually Transmitted Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Safer Sex Intervention for at-Risk Women in Mexico

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1800
Study Start Date: December 2003
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive the Share Safer Sex counseling program
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.
2: Active Comparator
Participants will receive a standard didactic safer-sex counseling session
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338845

Contacts
Contact: Prisciliana Orozovich, MPH 619-543-4738 porozovich@ucsd.edu

Locations
Mexico, B.C.
Study outreach clinic Recruiting
Tijuana, B.C., Mexico
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas L. Patterson, PhD Dept. of Psychiatry, University of California, San Diego
  More Information

Responsible Party: University of California, San Diego ( Thomas L. Patterson, Professor of Psychiatry )
Study ID Numbers: R01 MH65849, DAHBR 9A-ASI
Study First Received: June 16, 2006
Last Updated: February 14, 2008
ClinicalTrials.gov Identifier: NCT00338845  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
STDs

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009