Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial.
Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial.
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DOI：
10.1016/s2352-3018(22)00126-6
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发表时间：
2022-07
期刊：
影响因子：
16.1
通讯作者：
Baeten, Jared M.
中科院分区：
文献类型：
--
作者：
Ngure, Kenneth;Ortblad, Katrina F.;Mogere, Peter;Bardon, Ashley R.;Thomas, Katherine K.;Mangale, Dorothy;Kiptinness, Catherine;Gakuo, Stephen;Mbaire, Sarah;Nyokabi, Jacinta;Mugo, Nelly R.;Baeten, Jared M.
预防艾滋病毒的口服暴露前预防(PrEP)非常有效，正在整个撒哈拉以南非洲的卫生诊所推广。然而，以诊所为基础的PrEP交付的障碍仍然存在，例如客户和诊所的高昂成本。在一项随机实施试验中，我们旨在测试由临时家庭HIV自我检测(HIVST)支持的半年一次的PrEP诊所就诊是否会导致PrEP客户与季度就诊(护理标准)相比，获得同等的艾滋病毒检测、药物补充和依从性。在一项随机的非劣势试验(ClinicalTrials.gov NCT03593629)中，我们在肯尼亚测试了这种新的PrEP交付模式。所有受试者均为≥，年龄18岁，服药1个月。参与者按2：1随机分为：1)6个月的PrEP配药(每半年进行一次门诊，3个月后在家中进行HIVST支持)或2)标准护理PrEP配药(3个月供应，每季度就诊一次)。我们的主要结果，在六个月时衡量，是艾滋病毒检测(从登记到六个月的访问之间的任何测试)，PrEP重新填充，以及PrEP依从性(在干血点中可检测到替诺福韦-二磷酸)。我们使用二项回归模型估计风险差异(RD)，并将单边95%可信区间(CI)下限(LB)−10%解释为非劣势。从2018年5月到2020年2月，我们登记并跟踪了495名参与者：165名男性和130名女性，其中165名男性和130名女性在HIV血清不同的夫妇中，200名女性在已知的不同血清夫妇中。在6个月时，干预组83.3%(274/329)接受艾滋病毒检测，而标准护理组84.3%(140/166)(RD−1.2%，单侧95%CI-−6.9%)。在干预组的参与者中，78.1%(257/329)的患者重新填充了PREP，而标准护理组的参与者为80.7%(134/166)(RD−2.6%，单侧95%CI-−8.9%)。在干预组中，60·8%(2 0 0/32 9)的患者坚持PREP，而在标准护理组中，5 7·2%(95/16 6)(RD 2·4%，单侧95%CI L B−5·1%)。没有参与者感染艾滋病毒。六个月的PrEP免去HIVST进行中期测试，在不影响HIV检测、保留或依从性的情况下，PrEP诊所的就诊次数减少了一半。
Oral pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective and being scaled at health clinics throughout sub-Saharan Africa. However, barriers to clinic-based PrEP delivery such as high costs for clients and clinics remain. In a randomized implementation trial, we aimed to test whether semiannual PrEP clinic visits supported with interim home-based HIV self-testing (HIVST) would result in equivalent HIV testing, drug refilling, and adherence among PrEP clients compared to quarterly visits, the standard of care. In a randomized non-inferiority trial (ClinicalTrials.gov NCT03593629), we tested this novel model for PrEP delivery in Kenya. All participants were ≥18 years and had taken PrEP for one month. Participants were 2:1 randomized to: 1) six-month PrEP dispensing (with semiannual clinic visits, supported by HIVST conducted at home after three months) or 2) standard-of-care PrEP dispensing (three-month supply with quarterly clinic visits). Our primary outcomes, measured at six months, were HIV testing (any testing between enrollment and six-month visit), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate in dried blood spots). We used binomial regression models to estimate risk differences (RDs) and interpreted one-sided 95% confidence interval (CI) lower bounds (LB) −10% as non-inferior. From May 2018 to February 2020, we enrolled and followed 495 participants: 165 men and 130 women in HIV serodifferent couples and 200 women not in known serodifferent couples. At six months, 83·3% (274/329) in the intervention arm tested for HIV compared to 84·3% (140/166) in the standard-of-care arm (RD −1·2%, one-sided 95% CI LB −6·9%). Among participants in the intervention arm, 78·1% (257/329) refilled PrEP, compared to 80·7% (134/166) in the standard-of-care arm (RD −2·6%, one-sided 95% CI LB −8·9%). In the intervention arm, 60·8% (200/329) were adherent to PrEP compared to 57·2% (95/166) in the standard-of-care arm (RD 2·4%, one-sided 95% CI LB −5·1%). No participants acquired HIV. Six-month PrEP dispensing with HIVST for interim testing reduces the number of PrEP clinic visits in half without compromising HIV testing, retention, or adherence.