Evidence map›Paper›PMID 31416439›Full record

ArticleBMC infectious diseases2019

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 and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Hongyi WangNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Yonghui ZhangNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Zhu MeiNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Yueru JiaNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Sequoia I LeubaDepartment of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Jing ZhangNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Zhenxing ChuNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Haibo DingNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Yongjun JiangNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Wenqing GengNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China.
Hong ShangNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China. hongshang100@hotmail.com.ORCID http://orcid.org/0000-0001-5333-8943
Junjie XuNHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, No. 155, Nanjingbei Street, Heping District, Shenyang, 110001, Liaoning Province, China. xjjcmu@163.com.

Funding

the Mega-Projects of National Science Research of the 13th Five-Year Plan 2017ZX10201101the National Natural Science Foundation of China 81872674
6 · The paper itself

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. DISCUSSION: The 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.

Indexed as

Homosexuality, MaleAdultAnti-HIV AgentsChinaCohort StudiesEmtricitabineHIV InfectionsHumansMaleMulticenter Studies as TopicPre-Exposure ProphylaxisSafe SexSelf ReportSexual and Gender MinoritiesSexual BehaviorSurveys and QuestionnairesAnti-HIV AgentsEmtricitabineTenofovirHIVMSMPre-exposure prophylaxisPrEP

Identifiers

PMID31416439
PMCPMC6694544

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.