Clinical trial NCT00000931: HIV Prevention Counseling for Men Who Have Sex With Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Homosexuality, Male
Risk-Taking
Behavior Therapy
HIV Seronegativity
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 4350
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Dept of Hlth / AIDS Office
state: California
city: Denver
country: United States
facility: Denver Dept of Public Health / HIVNET
state: Colorado
city: Chicago
country: United States
facility: Howard Brown Health Ctr
state: Illinois
city: Boston
country: United States
facility: Fenway Community Health Ctr
state: Massachusetts
city: Bronx
country: United States
facility: New York Blood Ctr
state: New York
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
name: Chesney M, Coates T
role: STUDY_CHAIR
name: Koblin B
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/S0140-6736(04)16588-4.