Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial
Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial
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DOI：
10.1002/jia2.25491
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发表时间：
2020-05-01
影响因子：
6
通讯作者：
Baeten, Jared M.
中科院分区：
文献类型：
--
作者：
Beesham, Ivana;Welch, Julia D.;Baeten, Jared M.
简介 全球指南强调研究者的道德义务，即通过提供最佳的艾滋病毒预防方案来帮助艾滋病毒终点试验的参与者降低艾滋病毒风险。口服暴露前预防 (PrEP) 已日益成为最先进的艾滋病毒预防的一部分。在这里，我们描述了将口服 PrEP 递送纳入避孕选择证据和 HIV 结果 (ECHO) 试验的 HIV 预防包的过程。方法 ECHO 是一项开放标签随机临床试验，比较了随机使用三种有效避孕药之一的妇女的 HIV 发病率。 2015 年至 2018 年，来自四个非洲国家（斯威士兰、肯尼亚、南非和赞比亚）12 个地点的 7830 名 16 至 35 岁女性总共入组并进行了为期 12 至 18 个月的随访。在试验过程中，通过转介在场外或通过训练有素的试验人员在现场向研究参与者提供口服 PrEP。使用卡方检验或 t 检验比较不同避孕药具使用者之间的 PrEP 摄取情况。使用精确泊松回归比较从未启动过与曾经启动过 PrEP 的参与者之间的 HIV 血清发生率。结果 ECHO 于 2017 年 5 月开始在肯尼亚公开提供 PrEP，并于 2018 年 6 月在所有地点提供。当 PrEP 可用时，3626 名 (46.3%) 符合条件的女性仍在研究中进行随访，其中 622 名 (17.2%) 启动了 PrEP。开始 PrEP 的女性年龄稍大；更有可能未婚、不与伴侣同居、有多个伴侣；自己赚取收入并从合作伙伴那里获得经济支持的可能性较小（所有 p < 0.05）。 PrEP 启动在不同研究随机组之间没有差异 (p = 0.7)。三分之二的 PrEP 用户在研究退出时继续 PrEP。结论 需要在具有 HIV 终点的临床试验中改进 HIV 预防服务，特别是针对非洲妇女的试验。在大型临床试验中，PrEP 作为向妇女提供的全面艾滋病毒预防方案的一部分是切实可行的。在具有 HIV 结果的临床试验中提供 PrEP 应成为预防标准。
Introduction Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.Methods ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression.Results PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit.Conclusions There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.