Randomised controlled trial of a brief, clinic-based intervention to promote safer sex among young Black men who have sex with men: implications for pre-exposure prophylaxis-related counselling.

Background: The aim of this study was to determine the 3-month efficacy of a single-session, clinic-based intervention promoting condom use for anal and oral sex among HIV-uninfected Black young men who have sex with men (YBMSM). Methods: A pre-post test randomised controlled trial (RCT) was conducted from 2012 to 2015 using a 3-month period of observation. Recruitment and assessment occurred in sexually transmissible infection (STI) clinics. Men were randomised to either the intervention condition (n=142) or a standard-of-care control condition (n=135). The experimental condition comprised a single session of a one-to-one program designed for use in STI clinics. YBMSM completed both baseline and 3-month follow-up assessments. Outcomes measures were condomless anal insertive sex, condomless anal receptive sex and condomless oral sex. Results: Among men receiving the intervention, 11.2% (n=15) reported any condomless anal insertive sex at follow-up, compared with 20.6% (n=27) among controls (rate ratio=0.54, P=0.04). In addition, 12.0% (n=17) of men receiving the intervention reported any condomless anal receptive sex at follow-up, compared with 21.6% (n=29) among controls (rate ratio=0.55, P=0.03). When combining insertive and receptive anal sex, 18.3% (n=26) of men receiving the intervention reported any condomless sex, compared with 31.1% (n=42) among controls (rate ratio=0.59, P=0.01). Furthermore, 45.8% (n=33) of men receiving the intervention reported any condomless oral sex at follow-up, compared with 63.2% (n=48) among controls (rate ratio=0.72, P=0.03). Conclusions: This analysis of data from a Phase 3 RCT suggests that a single session of a clinic-based behavioural intervention may effectively promote the consistent use of condoms for anal and oral sex among HIV-uninfected YBMSM. The single-session program may be a valuable counselling tool for use in conjunction with recommended quarterly clinic appointments for YBMSM using pre-exposure prophylaxis.