HIV Prevention Counseling for Men Who Have Sex With Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000931
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : September 9, 2008
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

November 2, 1999
August 31, 2001
September 9, 2008
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Complete list of historical versions of study NCT00000931 on Archive Site
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HIV Prevention Counseling for Men Who Have Sex With Men
A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men

The purpose of this study is to see if a behavioral intervention, a special kind of counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral intervention will be compared to the standard risk reduction counseling that is given before and after getting an HIV test.

In standard pre- and post-test counseling, everyone is told the same things about how to prevent HIV. The behavioral intervention used in this study is designed to help each individual prevent HIV according to his specific problems and needs.

The intervention being evaluated in this trial is based on the extensive literature on behavioral approaches to risk reduction in MSM. These reviews recommend an intervention that, unlike the current standard HIV pre-test and post-test risk-reduction counseling, is tailored to an individual's unique problems and needs, lifestyle, and situations that contribute to high-risk behavior. Furthermore, there is a need for HIV-prevention intervention trials using biological endpoints (e.g., HIV seroconversion) in addition to behavioral change indices.

Participants are randomly assigned to receive either the behavioral intervention or the control risk-reduction counseling. The same counseling staff provides the two types of treatment. The behavioral intervention consists of 10 counseling sessions within a 4-month period followed by quarterly maintenance sessions for the remainder of the 3-year follow-up. The intervention is conducted on a one-to-one basis and targets condom use, change in sexual practices associated with HIV risk, and change in sexual practices in the context of alcohol and drug use. Participants in the control group receive pre- and post-test counseling at enrollment, then semiannually through Month 36. Beginning at Month 6, all participants complete routine semiannual visits. At each visit, Risk Assessment and phlebotomy for specimen collection for HIV antibody tests are administered. As is routine in most public counseling and testing venues, participants in the control condition do not see the same counselor consistently.

Phase 3
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Behavioral intervention
  • Behavioral: Risk-reduction counseling
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Koblin B, Chesney M, Coates T; EXPLORE Study Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet. 2004 Jul 3-9;364(9428):41-50.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Inclusion Criteria

Participants may be eligible for this study if they:

  • Are an HIV-negative man who has had anal sex with another man in the 12 months prior to study entry.
  • Are able to attend all scheduled study visits.
  • Are able to provide information for locator purposes (address, phone number, etc.).
  • Are at least 18 years old.

Exclusion Criteria

Participants will not be eligible for this study if they:

  • Have been in a monogamous relationship for 2 years or more with an HIV-negative man. (Monogamous is defined as a relationship in which the members of the couple engage in sexual activities with only each other.)
  • Have an obvious mental disorder or any another condition that would prevent them from completing the study.
  • Are currently enrolled in any Phase III HIV vaccine trial, including the AIDSVAX Phase III trial sponsored by VaxGen, Inc.
  • Are currently enrolled in HIVNET Protocol 014.
  • Were enrolled in the HIVNET 015 Pilot Study.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Chesney M, Coates T
Study Chair: Koblin B
National Institute of Allergy and Infectious Diseases (NIAID)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP