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

August 2, 2013 updated by: University of California, San Francisco

Changing Sexual Behavior in Gay Male Repeat HIV Testers: A Randomized Trial of a Single Session Counseling Intervention

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94102
        • UCSF AIDS Health Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in HIV infection risk behavior; measured at Months 6 and 12
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James W. Dilley, MD, UCSF AIDS Health Project
  • Principal Investigator: William J. Woods, PhD, UCSF Center for AIDS Prevention Studies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 5, 2013

Last Update Submitted That Met QC Criteria

August 2, 2013

Last Verified

August 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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