Background

Oral pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective and is being implemented at scale at health clinics throughout sub-Saharan Africa. However, barriers to clinic-based PrEP delivery remain. We aimed to establish the efficiency of semiannual PrEP clinic visits supplemented with interim home-based HIV self-testing (HIVST) versus standard of care for HIV testing, drug refilling, and adherence among PrEP users.

Methods

This was a randomised, open-label, non-inferiority trial done at the Partners in Health and Research Development clinic in Thika, Kenya. Eligible participants were HIV-negative adults (≥18 years) at risk of acquiring HIV who had started PrEP at least 1 month before enrolment. Participants were randomly assigned (1:1:1) to 6-month PrEP dispensing plus interim blood-based HIVST (with biannual clinic visits), 6-month PrEP dispensing plus interim oral fluid-based HIVST (with biannual clinic visits), or standard of care PrEP delivery (3-month PrEP dispensing with quarterly clinic visits). The three coprimary outcomes, measured at 6 months, were HIV testing (any testing between enrolment and the 6-month visit), PrEP refilling, and PrEP adherence (detectable tenofovir diphosphate concentration in dried blood spots). All analyses were done according to the intention-to-treat principle. We used binomial regression models to estimate risk differences and one-sided 95% CIs. 6-month PrEP dispensing was considered non-inferior to standard of care if the lower limit bound of the one-sided 95% CI was greater than or equal to –10%. This study is registered with ClinicalTrials.gov, NCT03593629.

Findings

Between May 28, 2018, and Feb 24, 2020, 495 participants were enrolled: 165 men and 130 women in HIV serodifferent couples and 200 singly enrolled women. 166 participants were randomly assigned to the standard of care group, 163 to the 6-month PrEP dispensing plus oral-fluid HIVST group, and 166 to the 6-month PrEP dispensing plus blood-based HIVST group. At 6 months, 274 (83%) of 329 participants in the combined 6-month PrEP dispensing group had tested for HIV compared with 140 (84%) of 166 participants in the standard of care group (risk difference –1·15%, 95% CI lower bound –6·89). Among participants in the combined 6-month PrEP dispensing group, 257 (78%) participants refilled PrEP compared with 134 (81%) participants in the standard of care group (–2·60%, –8·88), and 200 (61%) participants were adherent to PrEP compared with 95 (57%) participants in the standard of care group (2·37%, –5·05). No participants acquired HIV during the study.

Interpretation

6-month PrEP dispensing with HIVST for interim testing reduced the number of PrEP clinic visits in half without compromising HIV testing, retention, or adherence.

Funding

US National Institute of Mental Health.

中文翻译：

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肯尼亚 6 个月 PrEP 与 HIV 自检的效率：开放标签、随机、非劣效性实施试验

背景

口服暴露前预防（PrEP）对于预防艾滋病毒非常有效，并且正在整个撒哈拉以南非洲的卫生诊所大规模实施。然而，基于临床的 PrEP 实施的障碍仍然存在。我们的目的是确定半年一次的 PrEP 诊所就诊辅以临时家庭 HIV 自我检测 (HIVST) 的效率与 HIV 检测、药物补充和 PrEP 使用者的依从性的护理标准的比较。

方法

这是一项随机、开放标签、非劣效性试验，在肯尼亚锡卡的健康与研究开发合作伙伴诊所进行。符合资格的参与者是有感染 HIV 风险的 HIV 阴性成年人（≥18 岁），并且在入组前至少 1 个月开始 PrEP。参与者被随机分配 (1:1:1) 接受 6 个月 PrEP 配药加临时基于血液的 HIVST（每两年一次门诊就诊）、6 个月 PrEP 配药加临时基于口腔液体的 HIVST（每两年一次门诊就诊），或PrEP 护理标准交付（3 个月 PrEP 配药，每季度就诊）。6 个月时测量的三个共同主要结果是 HIV 检测（入组和 6 个月就诊之间的任何检测）、PrEP 补充和 PrEP 依从性（干血斑中可检测到的替诺福韦二磷酸盐浓度）。所有分析均根据意向治疗原则进行。我们使用二项式回归模型来估计风险差异和单边 95% CI。如果单侧 95% CI 的下限大于或等于 –10%，则 6 个月 PrEP 配药被认为不劣于标准护理。本研究已在 ClinicalTrials.gov 注册，NCT03593629。

发现

2018年5月28日至2020年2月24日期间，共有495名参与者入组：165名男性和130名女性感染HIV血清不同的夫妇，以及200名单独入组的女性。166 名参与者被随机分配到标准护理组，163 名参与者被分配到 6 个月 PrEP 配药加口服液 HIVST 组，166 名参与者被分配到 6 个月 PrEP 配药加血液 HIVST 组。6 个月时，联合 6 个月 PrEP 配药组的 329 名参与者中有 274 名 (83%) 进行了 HIV 检测，而标准护理组的 166 名参与者中有 140 名 (84%) 进行了 HIV 检测（风险差异 –1·15%， 95% CI 下限 –6·89)。在 6 个月 PrEP 配药组的参与者中，有 257 名 (78%) 参与者重新补充了 PrEP，而标准护理组有 134 名 (81%) 参与者 (–2·60%，–8·88)，200 名 (61%) 参与者坚持 PrEP，而标准护理组中有 95 名 (57%) 参与者 (2·37%, –5·05)。研究期间没有参与者感染艾滋病毒。

解释

6 个月的 PrEP 配发 HIVST 进行临时检测将 PrEP 诊所就诊次数减少了一半，且不影响 HIV 检测、保留或依从性。

资金

美国国家心理健康研究所。