Background

HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition. To enable routine commissioning of PrEP in England, we aimed to establish population need, duration of need, PrEP uptake, and duration of use in attendees of sexual health services (SHS) in England.

Methods

The Impact Trial was a prospective, open-label, single-arm, multicentre trial conducted at 157 SHS across England between Oct 13, 2017, and July 12, 2020. Clinicians assessed HIV-negative attendees for their risk of HIV acquisition to identify those who were eligible to participate and receive either daily or event-based oral PrEP (tenofovir disoproxil maleate with emtricitabine), as appropriate. Eligible participants were aged 16 years or older, considered HIV-negative on the day of enrolment, and willing to adhere to the trial procedures. Non-trial attendees are mutually exclusive of trial participants and included SHS attendees who were not recruited to the Impact Trial at any point. They include HIV-negative individuals aged 16 years or older who attended a participating SHS at least once after recruitment at that SHS had begun and before Feb 29, 2020. The main outcomes assessed were PrEP need, uptake, and use, and HIV and sexually transmitted infection (STI) incidence. Data are presented up to Feb 29, 2020, before the introduction of COVID-19 control measures. The study is registered with ClinicalTrials.gov, NCT03253757.

Findings

In this analysis, we include 21 356 of 24 268 participants enrolled before Feb 29, 2020. 20 403 participants (95·5%) were men who have sex with men (MSM). Uptake of PrEP among SHS attendees clinically assessed and coded as eligible was 21 292 (57·1%) of 37 289. 18 400 trial participants had at least one post-enrolment visit and a median of 361 days of follow-up (IQR 143–638); 14 039 (75·9%) of these had enough PrEP prescribed to provide protection for 75% of their follow-up time. Among MSM, HIV incidence was 0·13 (95% CI 0·08–0·19) per 100 person-years in trial participants (27 seroconversions) and 0·95 (95% CI 0·88–1·03) per 100 person-years in non-trial attendees (587 seroconversions; proportionate reduction of 86·8%, 95% CI 80·2–91·6). 18 607 bacterial STIs were recorded (incidence 68·1 per 100 person-years in trial participants who were MSM). 4343 (24·4%) MSM participants were diagnosed with two or more STIs, accounting for 14 800 (79·5%) of all 18 607 diagnoses.

Interpretation

PrEP need was higher than initially estimated by an expert stakeholder group. The high proportion of follow-up time protected by PrEP suggests that the need for protection persisted throughout trial participation for most participants. HIV incidence among MSM trial participants was low. The large unmet need for PrEP suggests that greater provision is required to maximise the potential of a national programme. The high incidence of bacterial STIs among participants, concentrated within a subgroup of PrEP users, presents an opportunity for tailored STI control measures.

Funding

NHS England.

中文翻译：

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HIV 暴露前预防及其在英国 PrEP 影响试验中的实施：实用的卫生技术评估

背景

HIV 暴露前预防 (PrEP) 对于预防 HIV 感染非常有效。为了能够在英格兰进行 PrEP 的常规调试，我们的目标是确定英格兰性健康服务 (SHS) 参与者的人口需求、需求持续时间、PrEP 的使用情况和使用持续时间。

方法

Impact 试验是一项前瞻性、开放标签、单组、多中心试验，于 2017 年 10 月 13 日至 2020 年 7 月 12 日在英格兰各地的 157 SHS 进行。临床医生评估了 HIV 阴性参与者感染 HIV 的风险，以确定这些参与者有资格参加并酌情接受每日或基于事件的口服 PrEP（马来酸替诺福韦二吡呋酯联合恩曲他滨）。符合资格的参与者年龄为 16 岁或以上，在入组当天被视为 HIV 呈阴性，并且愿意遵守试验程序。非试验参与者与试验参与者相互排斥，并包括在任何时候都没有被招募参加影响试验的 SHS 参与者。他们包括年龄 16 岁或以上的 HIV 阴性个体，在该 SHS 招募开始后和 2020 年 2 月 29 日之前至少参加过一次参与的 SHS。评估的主要结果是 PrEP 的需求、吸收和使用，以及 HIV 和性行为传播感染（STI）的发生率。数据截至 2020 年 2 月 29 日，即采取新冠肺炎 (COVID-19) 控制措施之前。该研究已在ClinicalTrials.gov注册，NCT03253757。

发现

在本次分析中，我们纳入了 2020 年 2 月 29 日之前登记的 24 268 名参与者中的 21 356 名。其中 20 403 名参与者 (95·5%) 是男男性行为者 (MSM)。经过临床评估和编码为合格的 SHS 参加者中，有 21 292 人 (57·1%) 接受了 PrEP。18 400 名试验参与者至少进行了一次入组后访视，中位随访时间为 361 天 (IQR 143) –638）；其中 14 039 名 (75·9%) 接受了足够的 PrEP 处方，可为他们 75% 的随访时间提供保护。在 MSM 中，试验参与者（27 名血清转化）中的 HIV 发病率为每 100 人年 0·13（95% CI 0·08–0·19），每 100 人年 HIV 发病率为 0·95（95% CI 0·88–1·03）。非试验参加者每年 100 人（587 例血清转化；比例减少 86·8%，95% CI 80·2–91·6）。记录了 18 607 例细菌性 STI（MSM 试验参与者的发病率为每 100 人年 68·1）。4343 名 (24·4%) MSM 参与者被诊断患有两种或两种以上性传播感染，占所有 18 607 名诊断中的 14 800 名 (79·5%)。

解释

PrEP 需求高于利益相关专家小组最初估计的水平。PrEP 保护的随访时间比例很高，表明大多数参与者在整个试验参与过程中始终需要保护。MSM 试验参与者的艾滋病毒感染率较低。PrEP 的大量未满足需求表明，需要提供更多资金来最大限度地发挥国家计划的潜力。参与者中细菌性传播感染的高发病率（集中在 PrEP 用户的一个亚组中）为制定量身定制的性传播感染控制措施提供了机会。

资金

英国国民医疗服务体系。