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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral intervention
Standard counseling
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, AIDS, MSM, Cognitive-Behavioral, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF AIDS Health Project
  • SFDPH San Francisco City Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive personalized cognitive counseling

Participants will receive standard counseling

Outcomes

Primary Outcome Measures

Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
April 30, 2012
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00218712
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, AIDS, MSM, Cognitive-Behavioral, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive personalized cognitive counseling
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive standard counseling
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention
Time Frame
Measured at Months 6 and 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James W. Dilley, MD
Organizational Affiliation
UCSF AIDS Health Project
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Schwarcz, MD, MPH
Organizational Affiliation
SFDPH-AIDS Office
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF AIDS Health Project
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
SFDPH San Francisco City Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

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

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