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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safer Sex Intervention for at-Risk Women in Mexico |
| Enrollment: | 1800 |
| Study Start Date: | December 2003 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
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Active Comparator: 2
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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Thomas L. Patterson, Professor of Psychiatry, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00338845 History of Changes |
| Other Study ID Numbers: | R01 MH065849, DAHBR 9A-ASI |
| Study First Received: | June 16, 2006 |
| Last Updated: | April 16, 2009 |
| Health Authority: | United States: Federal Government |
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STDs |
|
HIV Infections Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Infection Genital Diseases, Male Genital Diseases, Female |