What type of study is this?

This is a RCT study (also classified as: Pre-Registered Trial).

August 20, 2025JMIR Public Health and Surveillance0 citationsOpen Access

Tenofovir to Prevent HIV Infection in Western China: Pragmatic Randomized Controlled Trial

YTYi TaoThe Affiliated Yongchuan Hospital of Chongqing Medical University YZYan ZhangHenan Agricultural University BPBin PengHunan University

Key Points

TDF-based PrEP did not show significant efficacy without good adherence, indicating that medication compliance is crucial for prevention.
In a trial involving 1914 participants over 3513.5 person-years, HIV seroconversion occurred in 30, 35, and 37 individuals among the time-driven, event-driven, and control groups respectively.
Conducted as a pragmatic randomized controlled trial, this approach involved alternatives in dosing regimens for TDF to determine the best strategy for HIV prevention.
Successful tenofovir PrEP relies heavily on patient adherence, emphasizing the importance of understanding adherence behavior to lower HIV risk.

Abstract

Abstract Background Pre-exposure prophylaxis (PrEP) programs have been implemented in multiple countries. Evidence from clinical trials and cohort studies has proven the safety and effectiveness of PrEP. However, minimizing drug-related adverse effects and cost should be primarily considered in PrEP. Most trials used tenofovir combined with emtricitabine as the intervention; yet, the use of tenofovir disoproxil fumarate (TDF) (ie, Tenofovir) alone has not been thoroughly evaluated. Furthermore, the medication regimen in most trials was used every day, with a few studies proposing an optimal medication regimen for PrEP. Objective This study was designed to systematically evaluate the preventive efficacy and safety profile of TDF-based PrEP in the Chinese population. We also aimed to explore medication compliance, changes in sexual behavior, and hazard factors of HIV infection. Methods We conducted a pragmatic randomized controlled trial (RCT) to evaluate the effectiveness and safety of TDF for HIV PrEP. Participants were randomly assigned (1:1:1) to a time-driven group (TDF 300 mg administered orally once daily), an event-driven group (TDF 300 mg administered orally 24 to 48 h before sexual activity and 2 hours after sexual activity, not exceeding 300 mg within 24 h), or an untreated control group. The primary outcomes were the effectiveness and safety of TDF during periods of PrEP use. Secondary outcomes focused on the effectiveness of TDF among participants with good compliance during PrEP use. Tertiary outcomes included the risk factors of HIV infection and behavioral changes from PrEP initiation to the last visit. For ethical reasons, all participants received condoms and health education. This study was registered with the Chinese Clinical Trial Registry (ChiCTR-TRC-13003849). Results A total of 1914 participants underwent randomization. During the follow-up of 3513.5 person-years from June 2013 to May 2016, HIV seroconversion was observed in 30 persons (2.02 per 100 person-years) in the time-driven group (time-driven vs control group: hazard ratio HR 0.93, 95% CI 058‐1.51; P =.78), 35 (1.73 per 100 person-years) in the event-driven group (event-driven group vs control group: HR 0.83, 95% CI 0.52‐1.31; P =.42), and 37 (2.06 per 100 person-years) in the control group. Post hoc analysis showed that participants with good medication compliance reduced their HIV infection risk by 53% ( P =.01) and event-driven medication with good compliance reduced the risk by 62% ( P =.009). We recorded no severe adverse events during the trial. For tertiary outcomes, low medication compliance, sexual role, no condom use, and more number of sexual partners remained significantly associated with HIV risk. Conclusions The TDF-based PrEP is ineffective without good adherence. However, when medication compliance is achieved, event-driven dosing is recommended as an optimal PrEP regimen.

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