Real-time digital intervention on oral pre-exposure prophylaxis adherence among MSM: randomized controlled trial

Oral pre-exposure prophylaxis (PrEP) effectively prevents HIV among men who have sex with men, but its adherence faces significant hindrances. We evaluated the effectiveness of real-time digital intervention in promoting oral PrEP adherence through a randomized controlled trial using electronic medication monitors. The trial was registered on the Chinese Clinical Trial Registry (ChiCTR1900025604) and randomized 442 MSM to intervention (247) or control group (195). At the 6-month follow-up, the intervention group exhibited significantly higher oral PrEP adherence than the control (83.1% vs. 59.8%; adjusted net difference: 21.0%, 95% confidence interval: 12.9-29.2%, p < 0.001), while no differences were detected in the number of male sexual partners, condomless anal intercourse prevalence, or substance use disorder, with consistent results across both daily and event-driven oral PrEP regimens. Therefore, digital intervention significantly increased oral PrEP adherence over 6 months in the daily and event-driven subgroups but demonstrated no effect on high-risk behaviors.