Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial.
Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial.
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DOI：
10.1001/jamanetworkopen.2023.18590
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发表时间：
2023-06-01
影响因子：
13.8
通讯作者：
Ngure, Kenneth
中科院分区：
文献类型：
--
作者：
Ortblad, Katrina F.;Bardon, Ashley R.;Mogere, Peter;Kiptinness, Catherine;Gakuo, Stephen;Mbaire, Sarah;Thomas, Katherine K.;Mugo, Nelly R.;Baeten, Jared M.;Ngure, Kenneth
6个月的每日口服艾滋病毒暴露前预防（PrEP）配药与中期艾滋病毒自我检测支持减少每年PrEP诊所就诊的次数，而不危及客户在12个月的继续结果？在肯尼亚495名成年人中进行的一项随机非劣效性试验中，与标准的季度PrEP分发相比，半年度PrEP分发支持临时HIV自我检测，导致启动后1年的HIV检测和PrEP依从性非劣效。这项研究的结果表明，这种差异化的PrEP服务交付模式可以简化和优化PrEP交付。这项随机非劣效性试验评估了在中期HIV自我检测支持下，6个月暴露前预防（PrEP）分发是否会导致12个月时与标准季度门诊访视相比的非劣效性PrEP持续结局。每日口服艾滋病毒暴露前预防（PrEP）需要每季度到诊所进行艾滋病毒检测和药物补充，这对卫生系统和客户来说都是昂贵的。评估与标准季度门诊访视相比，6个月PrEP分发支持中期HIV自我检测（HIVST）是否在12个月时导致非劣效PrEP继续结局。这项随机非劣效性试验于2018年5月至2021年5月进行，在18岁或以上的PrEP客户中进行了12个月的随访，这些客户在肯尼亚基安布县的一家研究诊所进行了首次补充。参与者以2：1的比例随机分配到（1）6个月的PrEP分发，每半年一次的诊所访视和3个月的中期HIVST，或（2）标准护理（SOC）PrEP交付，3个月分发，每季度一次的诊所访视和基于诊所的HIV检测。预先规定的12个月结果包括最近的HIV检测（过去6个月内的任何检测）、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）。使用二项回归模型估计风险差异（RD），单侧95% CI下限（LB）为-10%或更高时视为非劣效性。共入组495例受试者，其中329例入组干预组，166例入组SOC组; 330例（66.7%）为女性，295例（59.6%）为血清学不同关系，中位（IQR）年龄为33（27-40）岁。在12个月时，干预组有241人（73.3%）和SOC组有120人（72.3%）返回诊所。在干预组中，近期HIV检测结果（230例[69.9%]）不劣于SOC组（116例[69.9%]; RD，− 0.33%，95%CI LB，−7.44%）。干预组的PrEP补充（196 [59.6%]）与SOC组相比不确定（104 [62.7%]; RD，−3.25%; 95% CI LB，−10.84%），干预组的PrEP依从性非劣效性（151例[45.9%]）与SOC组（70例[42.2%]; RD，4.96%; 95% CI LB，−2.46%）相比。在随访期间未观察到HIV血清转化。在对1年次要试验终点的分析中，与SOC季度PrEP分发相比，半年一次PrEP分发与中期HIVST导致近期HIV检测和PrEP依从性非劣效。这种新的模型有可能优化PrEP递送。ClinicalTrials.gov标识符：NCT 03593629
Does 6-month daily oral HIV preexposure prophylaxis (PrEP) dispensing supported with interim HIV self-testing reduce the number of annual PrEP clinic visits without jeopardizing client continuation outcomes at 12 months? In a randomized noninferiority trial among 495 adults in Kenya, semiannual PrEP dispensing supported with interim HIV self-testing resulted in noninferior HIV testing and PrEP adherence 1 year after initiation compared with standard quarterly PrEP dispensing. The findings of this study suggest that this differentiated model of PrEP service delivery could simplify and optimize PrEP delivery. This randomized noninferiority trial evaluated whether 6-month preexposure prophylaxis (PrEP) dispensing, supported by interim HIV self-testing, results in noninferior PrEP continuation outcomes at 12 months vs standard quarterly clinic visits. Daily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients. To evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits. This randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya. Participants were randomized 2:1 to (1) 6-month PrEP dispensing with semiannual clinic visits and interim HIVST at 3 months or (2) standard-of-care (SOC) PrEP delivery with 3-month dispensing, quarterly clinic visits, and clinic-based HIV testing. Prespecified 12-month outcomes included recent HIV testing (any in past 6 months), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate concentrations in dried blood spots). Binomial regression models were used to estimate risk differences (RDs), and a 1-sided 95% CI lower bound (LB) of −10% or greater was interpreted as noninferior. A total of 495 participants were enrolled, with 329 enrolled in the intervention group and 166 enrolled in the SOC group; 330 (66.7%) were women, 295 (59.6%) were in serodifferent relationships, and the median (IQR) age was 33 (27-40) years. At 12 months, 241 individuals in the intervention group (73.3%) and 120 in the SOC group (72.3%) returned to clinic. In the intervention group, recent HIV testing was noninferior (230 individuals [69.9%]) compared with the SOC group (116 [69.9%]; RD, −0.33%, 95% CI LB, −7.44%). PrEP refilling in the intervention group (196 [59.6%]) was inconclusive compared with the SOC group (104 [62.7%]; RD, −3.25%; 95% CI LB, −10.84%), and PrEP adherence was noninferior in the intervention group (151 [45.9%]) compared with the SOC group (70 [42.2%]; RD, 4.96%; 95% CI LB, −2.46%). No HIV seroconversions were observed over the follow-up period. In this analysis of secondary trial end points at 1 year, semiannual PrEP dispensing with interim HIVST resulted in noninferior recent HIV testing and PrEP adherence compared with SOC quarterly PrEP dispensing. This novel model has the potential to optimize PrEP delivery. ClinicalTrials.gov Identifier: NCT03593629
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影响因子：
16.1
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.
通讯作者：
Baeten, Jared M.
影响因子：
6
作者：
Wanga, Valentine;Omollo, Victor;Baeten, Jared M.
通讯作者：
Baeten, Jared M.
DOI：
10.1097/qai.0000000000001575
发表时间：
2018-02-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Mugwanya KK;Baeten JM;Wyatt C;Mugo NR;Celum CL;Ronald A;Kiarie J;Katabira E;Heffron R;Partners PrEP Study and Partners Demonstration Project Teams
通讯作者：
Partners PrEP Study and Partners Demonstration Project Teams
影响因子：
2.5
作者：
Ortblad, Katrina F.;Kearney, John E.;Ngure, Kenneth
通讯作者：
Ngure, Kenneth
影响因子：
8.4
作者：
Bigogo, Godfrey;Audi, Allan;Feikin, Daniel R.
通讯作者：
Feikin, Daniel R.