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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), April 2009
First Received: September 16, 2005   Last Updated: April 10, 2009   History of Changes
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

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

Resource links provided by NLM:


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: Matthew D. Skinta, PhD 415-502-8641 matthew.skinta@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

No publications provided

Responsible Party: University of California, San Francisco - Department of Psychiatry ( James W. Dilley, MD/Principal Investigator )
Study ID Numbers: R01 MH073425, DAHBR 9A-ASPQ
Study First Received: September 16, 2005
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00218712     History of Changes
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:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 01, 2009