Uptake, engagement, and adherence to pre-exposure prophylaxis offered after population HIV testing in rural Kenya and Uganda: 72-week interim analysis of observational data from the SEARCH study
Uptake, engagement, and adherence to pre-exposure prophylaxis offered after population HIV testing in rural Kenya and Uganda: 72-week interim analysis of observational data from the SEARCH study
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DOI：
10.1016/s2352-3018(19)30433-3
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发表时间：
2020-04-01
期刊：
影响因子：
16.1
通讯作者：
Havlir, Diane V.
中科院分区：
文献类型：
--
作者：
Koss, Catherine A.;Charlebois, Edwin D.;Havlir, Diane V.
背景暴露前预防（PrEP）参与广泛的HIV流行的最佳策略是未知的。我们的目的是评估PrEP摄取和参与后，人口水平的艾滋病毒检测和普及PrEP访问的PrEP级联在农村Kenya and Uganda.Methods中，我们做了一个72周的中期分析的观察数据，从正在进行的ESTA（可持续的东非社区卫生研究）研究。在社区宣传和PrEP教育之后，我们在肯尼亚西部，乌干达东部和乌干达西部的16个农村社区的健康博览会和设施中进行了艾滋病毒检测并提供PrEP。我们为15岁及以上的个人提供了增强的PrEP咨询，这些人根据血清差异伙伴关系或经验风险评分被评估为具有较高的艾滋病毒风险，或者其他自我确定为高风险但未在血清差异伙伴关系中或通过风险评分确定。PrEP后续访问在设施，家庭或社区地点进行。我们评估了艾滋病毒检测后90天内的PrEP吸收，计划参与（第4周，第12周和此后每12周随访一次），再填充，自我报告的依从性长达72周，以及报告艾滋病毒风险和依从性的个人头发样本中替诺福韦的浓度。这项研究已在ClinicalTrials.gov注册，NCT 01864603。结果在2016年6月6日至2017年6月23日期间，70379名15岁或15岁以上的社区居民在人群水平的艾滋病毒检测期间接受了检测。在这些个体中，69121人检测为HIV阴性，其中12935人具有升高的HIV风险（1353 [10%]血清不同的伙伴关系，6938 [54%]风险评分，4644 [36%]其他自我识别的风险）。3489人（27%）启动了PrEP，其中2865人（82%）在HIV检测当天进行，其中1733人（50%）为男性。15-24岁的个体（调整后的比值比为0.55，95% CI为0.45-0.68）和移动的个体（0.61，0.41-0.91）的PrEP摄取率较低。在第4周，在3466名开始PrEP并且在第一次访问之前没有退出或死亡的人中，2215人（64%）参与了该计划，1701人（49%）接受了药物补充，1388人（40%）自我报告遵守。在第72周，3274例患者中有1832例（56%）参与，1070例（33%）接受了再灌注，900例（27%）自我报告了依从性。在第4-72周报告艾滋病毒风险的参与者中，再填充（89-93%）和自我报告的依从性（70-76%）很高。在第24周自我报告依从性的抽样参与者中，头发中替诺福韦浓度反映每周至少服用4剂的比例为66%，反映每周服用7剂的比例为44%。停止PrEP的参与者在5140次后续访问中有4274次（83%）接受了HIV检测;这些参与者中有一半后来重新开始PrEP。五个不良事件（均为3级）被评估为可能与研究drug.Interpretation相关在人群水平的HIV检测，包容性风险评估（结合血清学不同的伙伴关系，经验风险评分，和自我识别的HIV风险）是可行的，并确定个人谁可以受益于PrEP。在PrEP级联的最大差距是PrEP摄取，特别是年轻和移动的个人。启动PrEP并在随访期间感知艾滋病毒风险的参与者报告服用PrEP，但三分之一的药物浓度与依从性差一致，这突出了随着PrEP推广的扩大，对新方法和长效制剂的需求。版权所有（C）2020作者。爱思唯尔有限公司出版
Background Optimal strategies for pre-exposure prophylaxis (PrEP) engagement in generalised HIV epidemics are unknown. We aimed to assess PrEP uptake and engagement after population-level HIV testing and universal PrEP access to characterise gaps in the PrEP cascade in rural Kenya and Uganda.Methods We did a 72-week interim analysis of observational data from the ongoing SEARCH (Sustainable East Africa Research in Community Health) study. Following community sensitisation and PrEP education, we did HIV testing and offered PrEP at health fairs and facilities in 16 rural communities in western Kenya, eastern Uganda, and western Uganda. We provided enhanced PrEP counselling to individuals 15 years and older who were assessed as having an elevated HIV risk on the basis of serodifferent partnership or empirical risk score, or who otherwise self-identified as being at high risk but were not in serodifferent partnerships or identified by the risk score. PrEP follow-up visits were done at facilities, homes, or community locations. We assessed PrEP uptake within 90 days of HIV testing, programme engagement ( follow-up visit attendance at week 4, week 12, and every 12 weeks thereafter), refills, self-reported adherence up to 72 weeks, and concentrations of tenofovir in hair samples from individuals reporting HIV risk and adherence during follow-up, and analysed factors associated with uptake and adherence. This study is registered with ClinicalTrials.gov, NCT01864603.Findings Between June 6, 2016, and June 23, 2017, 70 379 community residents 15 years or older who had not previously been diagnosed with HIV were tested during population-level HIV testing. Of these individuals, 69 121 tested HIV-negative, 12 935 of whom had elevated HIV risk (1353 [10%] serodifferent partnership, 6938 [54%] risk score, 4644 [36%] otherwise self-identified risk). 3489 (27%) initiated PrEP, 2865 (82%) of whom did so on the same day as HIV testing and 1733 (50%) of whom were men. PrEP uptake was lower among individuals aged 15-24 years (adjusted odds ratio 0.55, 95% CI 0.45-0.68) and mobile individuals (0.61, 0.41-0.91). At week 4, among 3466 individuals who initiated PrEP and did not withdraw or die before the first visit, 2215 (64%) were engaged in the programme, 1701 (49%) received medication refills, and 1388 (40%) self-reported adherence. At week 72, 1832 (56%) of 3274 were engaged, 1070 (33%) received a refill, and 900 (27%) self-reported adherence. Among participants reporting HIV risk at weeks 4-72, refills (89-93%) and self-reported adherence (70-76%) were high. Among sampled participants self-reporting adherence at week 24, the proportion with tenofovir concentrations in the hair reflecting at least four doses taken per week was 66%, and reflecting seven doses per week was 44%. Participants who stopped PrEP accepted HIV testing at 4274 (83%) of 5140 subsequent visits; half of these participants later restarted PrEP. 29 participants of 3489 who initiated PrEP had serious adverse events, including seven deaths. Five adverse events (all grade 3) were assessed as being possibly related to the study drug.Interpretation During population-level HIV testing, inclusive risk assessment (combining serodifferent partnership, an empirical risk score, and self-identification of HIV risk) was feasible and identified individuals who could benefit from PrEP. The biggest gap in the PrEP cascade was PrEP uptake, particularly for young and mobile individuals. Participants who initiated PrEP and had perceived HIV risk during follow-up reported taking PrEP, but one-third had drug concentrations consistent with poor adherence, highlighting the need for novel approaches and long-acting formulations as PrEP roll-out expands. Copyright (C) 2020 The Author(s). Published by Elsevier Ltd.