Chu Zhen-Xing, Jin Xia, Ye Ze-Hao, Zhu Yan-Yan, Huang Xiao-Jie, Wang Hui, Chen Yao-Kai, An Yu-Jing, Wu Zhen-Hao, Jiang Yong-Jun, Hu Qing-Hai, Shang Hong
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, NHC Key Laboratory of AIDS Prevention and Treatment, National Clinical Research Centre for Laboratory Medicine, The First Hospital of China Medical University, China Medical University, Shenyang, 110001, China.
Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, 110001, China.
NPJ Digit Med. 2025 Jun 11;8(1):349. doi: 10.1038/s41746-025-01743-7.
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.
口服暴露前预防（PrEP）能有效预防男男性行为者感染艾滋病毒，但其依从性面临重大障碍。我们通过一项使用电子药物监测器的随机对照试验，评估了实时数字干预在促进口服PrEP依从性方面的有效性。该试验已在中国临床试验注册中心注册（注册号：ChiCTR1900025604），将442名男男性行为者随机分为干预组（247人）和对照组（195人）。在6个月的随访中，干预组的口服PrEP依从性显著高于对照组（83.1%对59.8%；调整后的净差异：21.0%，95%置信区间：12.9 - 29.2%，p < 0.001），而在男性性伴侣数量、无保护肛交流行率或物质使用障碍方面未发现差异，每日和事件驱动的口服PrEP方案的结果一致。因此，数字干预在每日和事件驱动亚组中显著提高了6个月内的口服PrEP依从性，但对高危行为没有影响。
