Clinical trial NCT00218712: Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
AIDS
MSM
Cognitive-Behavioral
HIV Seronegativity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-22
Enrollment: 488
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention
timeFrame: Measured at Months 6 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF AIDS Health Project
state: California
city: San Francisco
country: United States
facility: SFDPH San Francisco City Clinic
state: California
Study officials:
affiliation: UCSF AIDS Health Project
name: James W. Dilley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SFDPH-AIDS Office
name: Sandra Schwarcz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: