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.
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.
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.
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.
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.
US National Institute of Mental Health.
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。
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。
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。
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。
美国国立心理健康研究所。
