Purpose: HIV has emerged as a leading cause of morbidity and mortality among men and women with severe mental disorders. The objective of this study is to test the efficacy of a cognitive-behavioral HIV sexual risk reduction intervention among men with severe mental disorders through a randomized controlled trial. The intervention grows out of our experience with two previous randomized trials with similar populations.

Methods: The sample consists of 149 sexually active men drawn from outpatient psychiatric clinics in high HIV-prevalence urban communities in and around New York City. All subjects received an initial HIV education session with instruction on condom use before being randomized to the experimental or control conditions. Men were then randomly assigned to either the experimental intervention, which comprised ten educational group sessions followed later by three maintenance sessions, or to the control money management intervention which also comprised ten educational group sessions followed by three maintenance sessions. The primary outcome was a composite index of sexual risk behavior during the follow-up period. Participants were followed for twelve months after the intervention, during which they were assessed at two time points.

Results: No significant differences in overall sexual risk behavior between the experimental and the control group were evident at either first or second six-month follow-up. There was a trend toward reduced sexual risk behavior at the first follow-up in the experimental group vs. controls among those sexually active at baseline, the comparison most in line with our previous studies. By the second follow-up, there was no evidence of a reduction in the sexual risk behavior. Apparently the booster sessions were not successful in maintaining whatever improvement might have occurred. The need to devise and test interventions that can effectively lead to long-term behavior change remains a critical challenge for this and other high risk populations.