Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya; Department of Global Health, University of Washington, Seattle, WA, USA.
Department of Global Health, University of Washington, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Lancet HIV. 2022 Jul;9(7):e464-e473. doi: 10.1016/S2352-3018(22)00126-6.
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.
背景：用于预防艾滋病毒的口服暴露前预防（PrEP）非常有效，正在撒哈拉以南非洲的各个卫生诊所大规模实施。然而，基于诊所的 PrEP 提供仍存在障碍。我们旨在确定每半年一次的 PrEP 诊所就诊与标准护理（用于艾滋病毒检测、药物补充和坚持使用 PrEP）相比，对 PrEP 使用者提供的艾滋病毒自我检测（HIVST）的补充，在预防艾滋病毒方面的效率。
方法：这是在肯尼亚提卡的健康伙伴关系和研究发展诊所进行的一项随机、开放标签、非劣效性试验。符合条件的参与者是 HIV 阴性的成年人（≥18 岁），他们有感染艾滋病毒的风险，在入组前至少已经开始使用 PrEP 1 个月。参与者被随机分配（1:1:1）到 6 个月的 PrEP 配药加临时基于血液的 HIVST（每半年进行一次诊所就诊）、6 个月的 PrEP 配药加临时基于口腔液的 HIVST（每半年进行一次诊所就诊）或标准护理 PrEP 给药（每 3 个月进行一次 PrEP 配药，每 3 个月进行一次诊所就诊）。三个主要结局指标在 6 个月时测量，分别是艾滋病毒检测（在入组和 6 个月就诊之间的任何检测）、PrEP 补充和 PrEP 坚持（在干血斑中检测到替诺福韦二磷酸浓度）。所有分析均根据意向治疗原则进行。我们使用二项回归模型来估计风险差异和单侧 95%置信区间。如果单侧 95%置信区间的下限大于或等于-10%，则认为 6 个月的 PrEP 配药与标准护理相比是非劣效的。这项研究在 ClinicalTrials.gov 上注册，编号为 NCT03593629。
结果：在 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 名女性在 HIV 血清不同的夫妇中，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 名到 6 个月的 PrEP 配药加口腔液 HIVST 组，166 名到 6 个月的 PrEP 配药加基于血液的 HIVST 组。在 6 个月时，与标准护理组的 140（84%）相比，联合 6 个月 PrEP 配药组的 329 名参与者中有 274（83%）接受了艾滋病毒检测（风险差异-1.15%，95%置信区间下限-6.89）。在联合 6 个月 PrEP 配药组的参与者中，与标准护理组的 134（81%）相比，257（78%）名参与者补充了 PrEP（-2.60%，-8.88），与标准护理组的 95（57%）相比，200（61%）名参与者坚持使用 PrEP（2.37%，-5.05）。在研究期间没有参与者感染艾滋病毒。
解释：每半年一次的 PrEP 配药加 HIVST 进行临时检测，将 PrEP 诊所就诊的次数减少了一半，而不会影响艾滋病毒检测、保留或坚持使用。
资金：美国国立心理健康研究所。
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