Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James W. Dilley, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00218712
First received: September 16, 2005
Last updated: April 30, 2012
Last verified: April 2012

September 16, 2005
April 30, 2012
September 2005
December 2010   (final data collection date for primary outcome measure)
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 ]
Reduction in HIV transmission risk behavior; measured 6 and 12 months following the intervention
Complete list of historical versions of study NCT00218712 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men
Reducing HIV Transmission Risk Behavior: a Trial of a Two Session Risk-Reduction Intervention With HIV-Positive Men Who Have Sex With Men

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
HIV Infections
  • 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.
  • 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.
  • Experimental: 1
    Participants will receive personalized cognitive counseling
    Intervention: Behavioral: Cognitive behavioral intervention
  • Active Comparator: 2
    Participants will receive standard counseling
    Intervention: Behavioral: Standard counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
March 2011
December 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218712
R01 MH073425, R01MH073425, DAHBR 9A-ASPQ
Yes
James W. Dilley, University of California, San Francisco
University of California, San Francisco
National Institute of Mental Health (NIMH)
Principal Investigator: James W. Dilley, MD UCSF AIDS Health Project
Principal Investigator: Sandra Schwarcz, MD, MPH SFDPH-AIDS Office
University of California, San Francisco
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP