Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected
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Purpose
This study will evaluate the effectiveness of a single specialized pre-test counseling session in reducing HIV infection risk behavior in men who are not HIV infected.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Behavioral: Cognitive-Behavioral Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Changing Sexual Behavior in Gay Male Repeat HIV Testers: A Randomized Trial of a Single Session Counseling Intervention |
- Reduction in HIV infection risk behavior; measured at Months 6 and 12 [ Time Frame: 6 and 12 months ]
| Enrollment: | 300 |
| Study Start Date: | August 2002 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
In San Francisco, HIV infection rates among men who have tested for HIV three or more times is almost triple the HIV infection rates of all other testers. Past research has shown that HIV uninfected gay and bisexual men who receive counseling are less likely to engage in high-risk sexual behavior. Counseling provided by trained mental health professionals within a clinical study setting helped individuals identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in unprotected sex. This study will focus on implementing a "real-world" counseling intervention designed specifically for men who are at the greatest risk of becoming infected with HIV: men who engage in high-risk sexual activity with other men and who repeatedly test for HIV. This specialized intervention will be administered by trained paraprofessional counselors during a pre-test counseling session prior to an HIV test. The purpose of this study is to evaluate the effectiveness of the specialized pre-test counseling intervention versus a standard pre-test counseling intervention in promoting safer sexual activity among HIV uninfected men. The men will have reported having unprotected sex with males of unknown HIV status or known HIV infection.
This 12-month study will enroll 300 men who will be recruited upon scheduling an anonymous HIV test at the participating clinic. Participants will be randomly assigned to receive either the enhanced pre-test counseling session or a standard pre-test counseling session prior to an HIV test. Outcome measurements will be assessed 6 and 12 months after the counseling session and will include self-reports of unprotected anal sex with non-primary partners and reported satisfaction levels with the pre-test counseling.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- History of two or more HIV antibody tests prior to study entry
- History of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry
Exclusion Criteria:
- History of injection drug use within 12 months of study enrollment
- Insufficient proficiency in English
Contacts and Locations| United States, California | |
| UCSF AIDS Health Project | |
| San Francisco, California, United States, 94102 | |
| Principal Investigator: | James W. Dilley, MD | UCSF AIDS Health Project |
| Principal Investigator: | William J. Woods, PhD | UCSF Center for AIDS Prevention Studies |
More Information
No publications provided
| Responsible Party: | James W. Dilley, MD/Principal Investigator, University of California, San Francisco - Department of Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00218699 History of Changes |
| Other Study ID Numbers: | R01 MH65138, DAHBR AZ-Q |
| Study First Received: | September 16, 2005 |
| Last Updated: | February 13, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
HIV MSM Men Who Have Sex With Men |
Cognitive-Behavioral HIV Counseling and Testing HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 19, 2013