Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP)

Hongyi Wang, Yonghui Zhang, Zhu Mei, Yueru Jia, Sequoia I. Leuba, Jing Zhang, Zhenxing Chu, Haibo Ding, Yongjun Jiang, Wenqing Geng, Hong Shang, Junjie Xu
2019 BMC Infectious Diseases  
Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent human immunodeficiency virus (HIV) transmission; however, context-specific data to guide optimal implementation are currently lacking in China. This study aims to systematically collect comprehensive, empirical data to determine effective ways to implement PrEP among at-risk men who have sex with men (MSM) in China. Methods: The CROPrEP project, a real-world study of PrEP use, will recruit 1000 high-risk HIV-negative
more » ... M participants from four cities in China, who will be able to choose between daily or event-driven dosing regimens, according to their preference. Participants will be followed up at months 1, 3, 6, 9, and 12 for PrEP provision, clinical evaluation, laboratory testing (e.g., emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) concentrations, and HIV/sexually transmitted infections), alongside detailed, self-administered online questionnaires regarding sexual behaviors, adherence, and attitudes. Online weekly notes will be used to record pill use and sexual practice. Various measurements will be triangulated to assess adherence, including: self-reported adherence, pill count, and drug concentration. A propensity score matching model will be fitted to examine the effectiveness of PrEP use in HIV seroconversion compared with non-PrEP users selected from a local expanding cohort study of HIV-1-negative MSM at participating research centers. Analyses using a generalized estimating equation model will focus on elucidation of the cascade of PrEP implementation, effectiveness, safety, and possible effects of PrEP use on sexual behaviors. This study will provide a comprehensive assessment of real-world PrEP use among Chinese MSM, to develop guidelines and strategies for PrEP implementation in China.
doi:10.1186/s12879-019-4355-y fatcat:hfcj5kasyjblloqurzffqyfwyu