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Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00218712
  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

MedlinePlus related topics: AIDS
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

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
1: Experimental
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.
2: Active Comparator
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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218712

Contacts
Contact: Lisa Loeb, DrPH 415-502-8641 lisa.loeb@ucsf.edu

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: James W. Dilley, MD UCSF AIDS Health Project
Principal Investigator: Sandra Schwarcz, MD, MPH SFDPH-AIDS Office
  More Information

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

Keywords provided by National Institute of Mental Health (NIMH):
HIV
AIDS
MSM
Cognitive-Behavioral
HIV Seronegativity

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009