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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00218712 |
This study will evaluate the effectiveness of a specialized cognitive-behavioral counseling intervention in reducing sexual risk behaviors in men who are HIV-infected and report having unprotected sex with male partners who are either not HIV-infected or do not know if they are HIV-infected.
Condition | Intervention |
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HIV Infections |
Behavioral: Cognitive behavioral intervention Behavioral: Standard counseling |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Reducing HIV Transmission Risk Behavior: a Trial of a Two Session Risk-Reduction Intervention With HIV-Positive Men Who Have Sex With Men |
Estimated Enrollment: | 376 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive personalized cognitive counseling
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Behavioral: Cognitive behavioral intervention
Cognitive behavioral intervention will include personalized cognitive counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
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2: Active Comparator
Participants will receive standard counseling
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Behavioral: Standard counseling
Participants will receive standard counseling. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later.
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Past research has shown that HIV-uninfected men who receive counseling regarding high-risk sexual behavior are less likely to engage in such behavior with other men. The rising rates of HIV infection among gay men suggest that some HIV-infected men are still engaging in high-risk sexual activity. There are several existing counseling interventions that focus on reducing high-risk sexual behavior, but the need exists for an intervention specifically targeted to HIV-infected men. This study will focus on the development of a specialized counseling intervention to help HIV-infected men identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in high-risk sexual activity with other men. In turn, this counseling may decrease the incidence of high-risk sexual behaviors, thereby reducing HIV infection rates among gay men. This study will evaluate the effectiveness of the specialized counseling intervention versus a standard risk-reduction counseling intervention in promoting safer sexual activity among HIV-infected men.
This study will consist of two phases. In Year 1, interviews will be conducted with 30 HIV-infected men who have engaged in high-risk unprotected sex within the previous 12 months with HIV-uninfected partners or partners with an unknown HIV status. The data resulting from these interviews will aid in the development of a specialized counseling intervention that is specifically geared for HIV-infected men. In Years 2 through 4, approximately 400 HIV-infected men will be randomly assigned to receive either the specialized counseling intervention or a standard counseling intervention. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later. Outcome measurements will be assessed at the second counseling session and again 6 months later, and will include self-reports of unprotected sex and laboratory testing for the presence of sexually transmitted diseases.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Loeb, DrPH | 415-502-8641 | lisa.loeb@ucsf.edu |
United States, California | |
UCSF AIDS Health Project | Recruiting |
San Francisco, California, United States, 94102 | |
Contact: Jessie Murphy, MPH 415-502-7275 jessie.murphy@ucsf.edu | |
Principal Investigator: James W. Dilley, MD | |
SFDPH San Francisco City Clinic | Recruiting |
San Francisco, California, United States, 94103 | |
Contact: Jeffrey Klausner, MD, MPH 415-355-2000 Jeff.Klausner@sfdph.org | |
Principal Investigator: Sandra Schwarcz, MD, MPH |
Principal Investigator: | James W. Dilley, MD | UCSF AIDS Health Project |
Principal Investigator: | Sandra Schwarcz, MD, MPH | SFDPH-AIDS Office |
Responsible Party: | University of California, San Francisco - Department of Psychiatry ( James W. Dilley, MD/Principal Investigator ) |
Study ID Numbers: | R01 MH73425, DAHBR 9A-ASPQ |
Study First Received: | September 16, 2005 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00218712 |
Health Authority: | United States: Federal Government |
HIV AIDS MSM Cognitive-Behavioral HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |