A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men

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.