Ryan Kathleen E, Mak Anne, Stoove Mark, Price Brian, Fairley Christopher K, Ruth Simon, Lal Luxshimi, Asselin Jason, El-Hayek Carol, Nguyen Long, Batrouney Colin, Wilson David, Lockwood John, Murphy Dean, Cornelisse Vincent J, Roth Norman, Willcox Jeff, Chang Christina C, Armishaw Judy, Tee Ban K, Penn Matthew, Forgan-Smith George, Williams Christopher, Montgomery Jeff, Byron Kat, Coelho Alison, Allen Brent, Wiggins Jeremy, Kelsall Jenny, Vujovic Olga, West Michael, Pierce Anna B, Gallant Daniel, Bell Charlotte, de Wit John B F, Hoy Jennifer F, Wesselingh Steve L, Grant Robert M, Wright Edwina J
The Burnet Institute, Melbourne, VIC, Australia.
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Front Public Health. 2018 May 29;6:151. doi: 10.3389/fpubh.2018.00151. eCollection 2018.
Pre-exposure prophylaxis (PrEP) is the use of HIV anti-retroviral therapy to prevent HIV transmission in people at high risk of HIV acquisition. PrEP is highly efficacious when taken either daily, or in an on-demand schedule. In Australia co-formulated tenofovir-emtricitabine is registered for daily use for PrEP, however, this co-formulation is not listed yet on the national subsidized medicines list. We describe a study protocol that aims to demonstrate if the provision of PrEP to up to 3800 individuals at risk of HIV in Victoria, Australia reduces HIV incidence locally by 25% generally and 30% among GBM. PrEPX is a population level intervention study in Victoria, Australia in which generic PrEP will be delivered to 3800 individuals for up to 36 months. Study eligibility is consistent with the recently updated 2017 Australian PrEP guidelines. Participants will attend study clinics, shared care clinics, or outreach clinics for quarterly HIV/STI screening, biannual renal function tests and other clinical care as required. Study visits and STI diagnoses will be recorded electronically through the ACCESS surveillance system. At each study visit participants will be invited to complete behavioral surveys that collect demographics and sexual risk data. Diagnosis and behavioral data will be compared between PrEPX participants and other individuals testing within the ACCESS surveillance system. A subset of participants will complete in depth surveys and interviews to collect attitudes, beliefs and acceptability data. Participating clinics will provide clinic level data on implementation and management of PrEPX participants. The population level impact on HIV incidence will be assessed using Victorian HIV notification data. This study will collect evidence on the real world impact of delivery of PrEP to 3800 individuals at risk of acquiring HIV in Victoria. This study will provide important information for the broader implementation of PrEP planning upon listing of the tenofovir-emtricitabine on the national subsidized list of medicines. The study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12616001215415).
暴露前预防（PrEP）是指使用抗逆转录病毒疗法来预防有感染艾滋病毒高风险的人群感染艾滋病毒。每日服用或按需服用PrEP都具有很高的疗效。在澳大利亚，替诺福韦-恩曲他滨复方制剂已注册用于PrEP的每日服用，但该复方制剂尚未列入国家补贴药品清单。我们描述了一项研究方案，旨在证明在澳大利亚维多利亚州为多达3800名有感染艾滋病毒风险的人提供PrEP是否能使当地艾滋病毒发病率总体降低25%，在男同性恋者中降低30%。PrEPX是在澳大利亚维多利亚州开展的一项人群水平干预研究，将向3800人提供通用型PrEP，为期最长36个月。研究资格符合最近更新的2017年澳大利亚PrEP指南。参与者将前往研究诊所、共享护理诊所或外展诊所，按季度进行艾滋病毒/性传播感染筛查，每半年进行一次肾功能测试，并根据需要接受其他临床护理。研究访视和性传播感染诊断将通过ACCESS监测系统进行电子记录。在每次研究访视时，将邀请参与者完成行为调查，收集人口统计学和性风险数据。将对PrEPX参与者与ACCESS监测系统内进行检测的其他个体的诊断和行为数据进行比较。一部分参与者将完成深入调查和访谈，以收集态度、信念和可接受性数据。参与研究的诊所将提供有关PrEPX参与者实施和管理的诊所层面数据。将使用维多利亚州艾滋病毒通报数据评估对艾滋病毒发病率的人群水平影响。本研究将收集关于在维多利亚州为3800名有感染艾滋病毒风险的人提供PrEP的现实世界影响的证据。本研究将为替诺福韦-恩曲他滨列入国家补贴药品清单后更广泛地实施PrEP规划提供重要信息。该研究已在澳大利亚新西兰临床试验注册中心注册（ACTRN12616001215415）。
