Evaluation of a Digital Intervention for Monitoring and Improving Medication Adherence Among Real-World e-Consumers of HIV Preexposure Prophylaxis in China: Protocol for a Randomized Controlled Trial

BACKGROUND: Preexposure prophylaxis (PrEP) is a key biomedical HIV prevention strategy that relies heavily on adherence for optimal effectiveness. In China, most PrEP users purchase their medication online, making it challenging to monitor and support adherence effectively. OBJECTIVE: This protocol aims to describe a digital intervention developed to monitor and improve the medication adherence of real-world e-consumers of PrEP and an evaluation plan assessing its acceptability, feasibility, and effectiveness. METHODS: The Real-Time Monitoring and Precision Intervention for HIV PrEP Adherence (REMOTE) trial is a parallel-group, open-label, online-delivered, active-controlled, and stratified randomized controlled trial conducted among 430 e-consumers of PrEP (320 event-driven regimen users and 110 daily regimen users) in China. People who have purchased PrEP online, have taken PrEP in the previous 3 months, and plan to continue for the next 6 months will be stratified by regimen type and randomized into control and intervention groups at a 1:1 ratio. A WeChat-based digital platform will deliver the REMOTE intervention. The monitoring module follows ecological momentary assessment principles. The intervention design is guided by the stages of change theory, tailoring strategies to different nonadherence risks based on monitoring results. Intervention components include low-risk (health education and an artificial intelligence chatbot), medium-risk (peer forum and admonitory education), and high-risk (customized reminders and physician counseling) strategies. The control group will use a simplified platform with only real-time monitoring. The primary outcome is the proportion of participants achieving optimal adherence for 6 months, assessed via real-time monitoring and validated via surveys at baseline and the 1-, 3-, and 6-month follow-ups. Secondary outcomes include PrEP adherence knowledge, self-efficacy, risk perception, adherence barriers, stigma, and social support, measured via surveys. Intention-to-treat analysis will be conducted. RESULTS: Funding for the study was approved in March 2024. Ethics approval for the study was granted in July 2024. The pilot trial was completed in November 2025. Baseline data collection commenced in January 2026. By February 5, 2026, recruitment and baseline data collection were completed, with 448 participants enrolled. The data have not been viewed by the research team. The intervention is currently ongoing, and the study is expected to conclude in August 2026. Results are anticipated to be published in early 2027. CONCLUSIONS: The REMOTE trial pioneers a real-time monitoring and precision intervention for e-consumers of PrEP. Leveraging technology and ecological momentary assessment, it delivers a personalized, real-time intervention that is crucial for adherence. The findings could significantly impact future HIV prevention strategies. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400088278; https://www.chictr.org.cn/showproj.html?proj=236414. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/92750.