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Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, MSM Men Who Have Sex with Men, Men Who Have Sex With Men, Cognitive-Behavioral, HIV Counseling and Testing, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: History of two or more HIV antibody tests prior to study entry History of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry Exclusion Criteria: History of injection drug use within 12 months of study enrollment Insufficient proficiency in English

Sites / Locations

  • UCSF AIDS Health Project

Outcomes

Primary Outcome Measures

Reduction in HIV infection risk behavior; measured at Months 6 and 12

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
August 2, 2013
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00218699
Brief Title
Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected
Official Title
Changing Sexual Behavior in Gay Male Repeat HIV Testers: A Randomized Trial of a Single Session Counseling Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effectiveness of a single specialized pre-test counseling session in reducing HIV infection risk behavior in men who are not HIV infected.
Detailed Description
In San Francisco, HIV infection rates among men who have tested for HIV three or more times is almost triple the HIV infection rates of all other testers. Past research has shown that HIV uninfected gay and bisexual men who receive counseling are less likely to engage in high-risk sexual behavior. Counseling provided by trained mental health professionals within a clinical study setting helped individuals identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in unprotected sex. This study will focus on implementing a "real-world" counseling intervention designed specifically for men who are at the greatest risk of becoming infected with HIV: men who engage in high-risk sexual activity with other men and who repeatedly test for HIV. This specialized intervention will be administered by trained paraprofessional counselors during a pre-test counseling session prior to an HIV test. The purpose of this study is to evaluate the effectiveness of the specialized pre-test counseling intervention versus a standard pre-test counseling intervention in promoting safer sexual activity among HIV uninfected men. The men will have reported having unprotected sex with males of unknown HIV status or known HIV infection. This 12-month study will enroll 300 men who will be recruited upon scheduling an anonymous HIV test at the participating clinic. Participants will be randomly assigned to receive either the enhanced pre-test counseling session or a standard pre-test counseling session prior to an HIV test. Outcome measurements will be assessed 6 and 12 months after the counseling session and will include self-reports of unprotected anal sex with non-primary partners and reported satisfaction levels with the pre-test counseling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, MSM Men Who Have Sex with Men, Men Who Have Sex With Men, Cognitive-Behavioral, HIV Counseling and Testing, HIV Seronegativity

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Intervention
Primary Outcome Measure Information:
Title
Reduction in HIV infection risk behavior; measured at Months 6 and 12
Time Frame
6 and 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: History of two or more HIV antibody tests prior to study entry History of at least one episode of unprotected anal intercourse (receptive or insertive) within 12 months prior to study entry Exclusion Criteria: History of injection drug use within 12 months of study enrollment Insufficient proficiency in English
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
William J. Woods, PhD
Organizational Affiliation
UCSF Center for AIDS Prevention Studies
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

12. IPD Sharing Statement

Learn more about this trial

Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected

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