Abstract
BackgroundPre-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.MethodsThe CROPrEP project, a real-world study of PrEP use, will recruit 1000 high-risk HIV-negative MSM 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.DiscussionThe CROPrEP project is the first study of the TDF/FTC combination as PrEP in China, which will provide primary data on PrEP implementation, including: the cascade of PrEP use, “real-world” effectiveness, adherence, and safety. The findings from this study have potential to be vital for promoting the integration of PrEP within the portfolio of HIV prevention interventions and developing guidance on PrEP implementation in China.Trial registrationChiCTR-IIN-17013762 (Chinese Clinical Trial Registry). Date of registration: 8 December 2017.
Highlights
Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent human immunodeficiency virus (HIV) transmission; context-specific data to guide optimal implementation are currently lacking in China
In China, men who have sex with men (MSM) account for more than a quarter of overall new HIV infections [1] and this proportion has doubled in the last decade [2]; MSM represent a key population with an increasing trend of HIV incidence rate over time [3]
The coformulation of 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF) (TDF/ FTC, Truvada®) is the only drug approved by the US Food and Drug Administration for pre-exposure prophylaxis
Summary
Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent human immunodeficiency virus (HIV) transmission; 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. Pre-exposure prophylaxis (PrEP) refers to a promising prevention strategy, where people uninfected with HIV use antiretroviral drugs to prevent acquisition of the virus, and has been recommended by the World Health Organization and Centers for Disease Control and Prevention (CDC) in the United States for HIV prevention [7,8,9]. Despite the continued expansion of the PrEP strategy, there are socio-cultural contexts and healthcare infrastructure gaps between low- and middleincome countries (including China) and developed countries, which represent particular challenges for the former in the implementation of PrEP, necessitating a cautious approach [17]
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