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

Abstract

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.

The effectiveness of sexual health interventions for people with severe mental illness: a systematic review

“…Of these, 13 studies (representing 14 references) 31,[46][47][48][49][50][51][52][53][54][55][56][57][58] met the inclusion criteria. These studies were all defined by the authors as RCTs.…”

“…), outpatient psychiatric clinics [Berkman et al, 48 Carey et al, 49 Kalichman et al, 51 Kelly et al, 31 National Institute of Mental Health (NIMH), 57 Otto-Salaj et al 55 and Weinhardt et al…”

“…The standard care in the control groups included educational sessions on HIV (Berkman et al, 46,47 Kelly et al, 31 Linn et al 53 and NIMH 57 ), money management (Berkman et al, 48 Collins et al 50 and Susser et al…”

“…There was also variation in the ethnicity of participants between the studies, with seven studies reporting the majority of participants to be African Americans (Berkman et al, 46,47 Berkman et al, 48 Linn et al, 53 Malow et al, 54 NIMH, 57 Otto-Salaj et al 55 and Susser et al…”

“…One study did not report information on the ethnicity of the participants. 52 Only four studies reported information regarding the marital status of participants (Berkman et al, 48 Carey et al, 49 Kalichman et al 51 and Malow et al…”