HIV prevention with severely mentally ill men: A randomised controlled trial

We conducted a randomised clinical trial to test the efficacy of an enhanced version of an intervention previously shown to reduce HIV sexual risk behaviours among men with severe mental illness. One-hundred-and-forty-nine subjects aged 18-59 years were randomly assigned to the experimental or control conditions. Sexual risk behaviours were assessed every three months for 12-months. The primary analysis compared experimental and control groups with respect to sexual risk behaviours with casual partners as measured by the Vaginal Episodes Equivalent ( VEE) score. Additional analyses included comparison of VEE scores of those men sexually active in the three months prior to baseline and the proportion of condom-protected sexual acts with casual partners. There were no significant differences in sexual risk behaviours with casual partners between experimental and control subjects. Additional analyses demonstrated a trend toward sexual risk reduction at six months post-intervention ( p = 0.06) but not at 12 months. These results may reflect a lack of efficacy or a true reduction in risk that the trial was underpowered to detect at the 0.05-level. If there was a true reduction in risk, it was not maintained after the initial six months.