The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men

Objectives We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men’s Safer Sex website, measuring condom use and sexually transmitted infection (STI). Methods For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care (n = 84), or usual clinic care only (n = 75). Online outcome data were solicited at 3, 6, and 12 months. Results Men were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website (n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90). Conclusion It is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings. Trial registration number: ISRCTN18649610