Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial.
Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial.
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口服艾滋病毒暴露前预防（PrEP）用于预防艾滋病毒非常有效，但非洲的使用率仍然很低，特别是在年轻妇女中，她们是艾滋病毒预防服务的优先人群。艾滋病毒自我检测（HIVST）已被证明可以增加不同人群的艾滋病毒检测，但在支持与艾滋病毒预防服务的联系方面没有得到充分利用。在非洲，大多数开始PrEP的年轻妇女都是通过非正式的同行推荐来进行的。我们想测试一个正式的同行转介模式，加强与艾滋病毒/艾滋病传播的年轻肯尼亚妇女。Peer PrEP试验是一项在肯尼亚中部进行的双臂混合有效性实施群集随机对照试验。合格参与者（即，同行提供者，n = 80）是在公共医疗诊所补充或开始PrEP的女性（≥ 16-24岁），她们可以确定至少4名可以从PrEP中受益且未参加另一项HIV研究的同行。同行提供者将1：1随机分配到（1）正式的同行PrEP转介+ HIVST交付，鼓励他们转介四个同行（即，同伴客户，≥ 16-24岁）使用教育材料和HIVST工具包（每个同伴客户两个），或（2）非正式的同伴PrEP转介，鼓励他们使用非正式的口碑转介四个同伴客户。在这两种情况下，同行提供者将提供标准的PrEP转介卡，其中包含附近提供PrEP服务的公共诊所的信息。同行提供者将在基线和3个月完成调查;同行客户将在3个月完成调查。我们的主要结果是在同行客户中启动PrEP，正如同行提供者在3个月时所报告的那样。次要结果包括PrEP持续（任何再填充），HIV检测（过去3个月），性行为（过去一个月）和PrEP依从性（过去一个月），如同行提供者和客户在3个月时所报告的。实施结果将包括参与者对干预措施的可接受性、适当性和可行性的看法，以及对干预措施的可信度和成本的评估。这项试验的证据将帮助我们了解HIVST如何通过促进在肯尼亚和类似环境中受益的年轻女性与PrEP服务的联系来支持卫生系统。ClinicalTrials.gov NCT04982250。于2021年7月29日注册。在线版本包含补充材料，可通过10.1186/s13063-023-07734-x获得。
Oral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women. The Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16–24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16–24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants’ perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention’s fidelity and cost. Evidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings. ClinicalTrials.gov NCT04982250. Registered on July 29, 2021. The online version contains supplementary material available at 10.1186/s13063-023-07734-x.
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影响因子：
3.4
作者：
Calhoun LM;Mirzoyants A;Thuku S;Benova L;Delvaux T;van den Akker T;McGuire C;Onyango B;Speizer IS
通讯作者：
Speizer IS
DOI：
10.1016/s2352-3018(20)30307-6
发表时间：
2021-03
期刊：
The lancet. HIV
影响因子：
--
作者：
Haberer JE;Bukusi EA;Mugo NR;Pyra M;Kiptinness C;Oware K;Garrison LE;Thomas KK;Musinguzi N;Morrison S;Anderson PL;Ngure K;Baeten JM;MPYA Study Team
通讯作者：
MPYA Study Team
DOI：
10.1097/qai.0000000000000124
发表时间：
2014-05-01
影响因子：
3.6
作者：
Kimanga, Davies O.;Ogola, Samuel;Kim, Andrea A.
通讯作者：
Kim, Andrea A.
影响因子：
4.6
作者：
Kelvin EA;Akasreku B
通讯作者：
Akasreku B
影响因子：
168.9
作者：
Choopanya, Kachit;Martin, Michael;Vanichseni, Suphak
通讯作者：
Vanichseni, Suphak