HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya
HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya
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DOI：
10.1186/s13063-019-3521-2
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发表时间：
2019-07-04
期刊：
影响因子：
2.5
通讯作者：
Ngure, Kenneth
中科院分区：
文献类型：
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作者：
Ortblad, Katrina F.;Kearney, John E.;Ngure, Kenneth
背景在非洲引入暴露前预防 (PrEP) 来预防人类免疫缺陷病毒 1 (HIV-1)，这给已经不堪重负的卫生系统带来了新的挑战，因为 PrEP 的实施需要频繁的就诊（通常每 3 个月一次）进行 HIV-1 检测和 PrEP 补充。 HIV-1 自检 (HIVST) 有可能通过减少就诊次数来提高 PrEP 实施的效率。在这里，我们描述了一项随机、非劣效性试验的基本原理和设计，该试验旨在测试在肯尼亚使用 HIVST 支持 PrEP 实施的有效性和安全性。 方法 JiPime-JiPrEP（斯瓦希里语“Test Yourself”，“PrEP Yourself”）研究是一项在肯尼亚锡卡进行的三组随机试验。参与者 (n=495) 如果年满 18 岁、HIV-1 血清阴性且已服用 PrEP 1 个月，则有资格参加。将招募三种不同的参与者类型：处于相互披露的 HIV-1 血清不一致关系的男性 (n=165) 和女性 (n=165)，以及处于 HIV-1 风险但不处于已知血清不一致关系的女性 (n=165)。每个亚群的参与者将按 1:1:1 随机分配至： 1) 标准护理，每季度门诊就诊； 2) 口服 HIVST，每年两次就诊，并在两次就诊之间的季度使用口服 HIVST；或 3) 基于血液的 HIVST，每年两次就诊，加上基于血液的 HIVST。所有参与者将完成定量调查并提供血液样本，以客观测量基线、6 个月和 12 个月的 PrEP 依从性。主要结果是 PrEP 依从性、PrEP 持续性和 HIV-1 检测，分别在 6 个月时测量，其次在 12 个月时测量。讨论 该试验的结果有助于了解 HIVST（一种新的 HIV-1 检测技术）如何支持撒哈拉以南非洲的卫生系统。此外，研究结果还可以为旨在提高肯尼亚 PrEP 实施和扩大规模的政策提供信息。试验注册ClinicalTrials.gov，NCT03593629。追溯注册日期为2018年7月20日。
BackgroundThe introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya.MethodsThe JiPime-JiPrEP (Kiswahili for Test Yourself, PrEP Yourself') study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n=495) are eligible for enrollment if they are at least 18years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n=165) and women (n=165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n=165) who areat HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for theobjective measurement of PrEP adherence at baseline, 6months, and 12months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6months and secondarily at 12months.DiscussionThe findings from this trial can help to understand how HIVST-a new HIV-1 testingtechnology-can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya.Trial registrationClinicalTrials.gov, NCT03593629. Retrospectively registered on 20 July 2018.