Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men
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Purpose
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 |
|---|---|
|
HIV Infections |
Behavioral: Cognitive behavioral intervention Behavioral: Standard counseling |
| 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: | Reducing HIV Transmission Risk Behavior: a Trial of a Two Session Risk-Reduction Intervention With HIV-Positive Men Who Have Sex With Men |
- Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
| Enrollment: | 488 |
| Study Start Date: | September 2005 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive personalized cognitive counseling
|
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.
|
|
Active Comparator: 2
Participants will receive standard counseling
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-infected
- Currently receiving HIV-specific primary medical care or mental health care
- Reports at least one episode of unprotected sex (receptive or insertive) with a male partner who is either not infected or does not know if he is infected with HIV (within 12 months prior to study enrollment)
- Plans to live in the San Francisco Bay Area for the next 12 months
Exclusion Criteria:
- History of intercourse on a regular basis with only one person
- Insufficient understanding of English
- Cognitive disorder that may affect ability to give informed consent
- Currently enrolled in any other behavioral or clinical HIV trials that could affect participation in this study
Contacts and Locations| United States, California | |
| UCSF AIDS Health Project | |
| San Francisco, California, United States, 94102 | |
| SFDPH San Francisco City Clinic | |
| San Francisco, California, United States, 94103 | |
| Principal Investigator: | James W. Dilley, MD | UCSF AIDS Health Project |
| Principal Investigator: | Sandra Schwarcz, MD, MPH | SFDPH-AIDS Office |
More Information
No publications provided
| Responsible Party: | James W. Dilley, Principal Investigator, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00218712 History of Changes |
| Other Study ID Numbers: | R01 MH073425, R01MH073425, DAHBR 9A-ASPQ |
| Study First Received: | September 16, 2005 |
| Last Updated: | April 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Francisco:
|
HIV AIDS MSM Cognitive-Behavioral 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