HIV Infections Clinical Trial
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
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.
;
Intervention Model: Parallel Assignment, Primary Purpose: Prevention
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