Clinical Trials


HIV Prevention Counseling for Men Who Have Sex With Men

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: November 2, 1999
Last updated: September 8, 2008
Last Verified: November 2006
History of Changes


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.

Condition Intervention Phase
HIV Infections

Behavioral : Behavioral intervention
Behavioral : Risk-reduction counseling
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 4350

Detailed Description:

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.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  


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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00000931


United States, California
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States, 94102
United States, Colorado
Denver Dept of Public Health / HIVNET
Denver, Colorado, United States, 80204
United States, Illinois
Howard Brown Health Ctr
Chicago, Illinois, United States, 60613
United States, Massachusetts
Fenway Community Health Ctr
Boston, Massachusetts, United States, 02115
United States, New York
New York Blood Ctr
Bronx, New York, United States, 10456
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)


Study Chair: Chesney M, Coates T
Study Chair: Koblin B
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000931   History of Changes  
Other Study ID Numbers: HIVNET 015  
Study First Received: November 2, 1999  
Last Updated: September 8, 2008  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Homosexuality, Male
Behavior Therapy
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections processed this data on April 09, 2020
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