澳大利亚新南威尔士州社区扩大艾滋病毒暴露前预防（PrEP）实施（EPIC-NSW）：一项开放性、单臂实施试验的设计。
Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial.
机构信息
The Kirby Institute, University of New South Wales, Sydney, 2052, Australia.
NSW Ministry of Health, Sydney, NSW, Australia.
出版信息
BMC Public Health. 2018 Feb 2;18(1):210. doi: 10.1186/s12889-017-5018-9.
BACKGROUND
The New South Wales (NSW) HIV Strategy 2016-2020 aims for the virtual elimination of HIV transmission in NSW, Australia, by 2020. Despite high and increasing levels of HIV testing and treatment since 2012, the annual number of HIV diagnoses in NSW has remained generally unchanged. Pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infection among gay and bisexual men (GBM) when taken appropriately. However, there have been no population-level studies that evaluate the impact of rapid PrEP scale-up in high-risk GBM. Expanded PrEP Implementation in Communities in NSW (EPIC-NSW) is a population-level evaluation of the rapid, targeted roll-out of PrEP to high-risk individuals.
METHODS
EPIC-NSW, is an open-label, single-arm, multi-centre prospective observational study of PrEP implementation and impact. Over 20 public and private clinics across urban and regional areas in NSW have participated in the rapid roll-out of PrEP, supported by strong community mobilization and PrEP promotion. The study began on 1 March 2016, aiming to enroll at least 3700 HIV negative people at high risk of HIV. This estimate took into consideration criteria for PrEP prescription in people at high risk for acquiring HIV as defined in the NSW PrEP guidelines. Study participants receive once daily co-formulated tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) and are followed for up to 24 months. Follow-up includes: testing for HIV at 1 month, HIV and other sexually transmissible infections three-monthly, HCV annually and monitoring of renal function six-monthly. Optional online behavioural surveys are conducted quarterly. The co-primary endpoints are (i) HIV diagnoses and incidence in the cohort and (ii) HIV diagnoses in NSW.
DISCUSSION
EPIC-NSW is a population-based PrEP implementation trial which targets the entire estimated population of GBM at high risk for HIV infection in NSW. It will provide a unique opportunity to evaluate the population impact of PrEP on a concentrated HIV epidemic.
TRIAL REGISTRATION
https://clinicaltrials.gov/ (identifying number NCT02870790 ; registration date 14 August 2016), pre-results stage.
背景
新南威尔士州（新州）2016-2020 年艾滋病毒战略旨在到 2020 年在澳大利亚新州实现艾滋病毒传播的实际消除。尽管自 2012 年以来艾滋病毒检测和治疗的水平不断提高，但新州的艾滋病毒诊断年度数量基本保持不变。在适当使用的情况下，暴露前预防（PrEP）在预防男同性恋和双性恋者（GBM）感染艾滋病毒方面非常有效。然而，还没有进行针对高危 GBM 人群中 PrEP 快速推广的人群水平研究。新南威尔士州社区中扩大 PrEP 的实施（EPIC-NSW）是对 PrEP 快速、有针对性地推广给高危人群的人群水平评估。
方法
EPIC-NSW 是一项针对 PrEP 实施和影响的开放性、单臂、多中心前瞻性观察研究。新州的城市和地区的 20 多家公立和私立诊所参与了 PrEP 的快速推广，同时还开展了强大的社区动员和 PrEP 宣传。该研究于 2016 年 3 月 1 日开始，目标是招募至少 3700 名 HIV 阴性的高艾滋病毒风险人群。这一估计考虑了新州 PrEP 指南中定义的高危人群获得 HIV 的 PrEP 处方标准。研究参与者每天服用一次富马酸替诺福韦二吡呋酯和恩曲他滨（TDF/FTC），并随访 24 个月。随访包括：第 1 个月进行 HIV 检测、每 3 个月进行 HIV 和其他性传播感染检测、每年进行 HCV 检测以及每 6 个月进行肾功能监测。每季度进行可选的在线行为调查。主要终点是（i）队列中的 HIV 诊断和发病率和（ii）新州的 HIV 诊断。
讨论
EPIC-NSW 是一项基于人群的 PrEP 实施试验，针对新州所有估计的 HIV 感染高危 GBM 人群。它将提供一个独特的机会来评估 PrEP 对集中性 HIV 流行的人群影响。
试验注册
https://clinicaltrials.gov/（识别号 NCT02870790；注册日期 2016 年 8 月 14 日），预结果阶段。
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