Twenty-four-month outcomes from a cluster-randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs.
Twenty-four-month outcomes from a cluster-randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs.
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DOI：
10.1002/jia2.25649
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发表时间：
2020-12
影响因子：
6
通讯作者：
Wilkinson L
中科院分区：
文献类型：
--
作者：
Cassidy T;Grimsrud A;Keene C;Lebelo K;Hayes H;Orrell C;Zokufa N;Mutseyekwa T;Voget J;Gerstenhaber R;Wilkinson L
抗逆转录病毒疗法坚持俱乐部（AC）模式支持临床稳定的艾滋病毒患者保留集体抗逆转录病毒疗法补充和心理社会支持。通过将抗逆转录病毒治疗的补充时间增加到6个月来减少就诊频率，可以进一步使患者受益，并减轻卫生系统的负担。我们在南非Khayelitsha的一家初级保健机构进行了一项实用的非劣效性随机分组试验，比较了标准治疗（SoC）AC和6个月的补充干预AC。现有的基于社区和基于机构的AC被随机分配到SoC或干预AC。SoC AC每年举行五次会议，在年底接受两个月的补充和四个月的补充。在一次AC访视时抽血，并在下一次进行临床评估。干预AC每年会面两次，接受6个月的再填充，在年度临床评估AC访视前进行个体采血访视。第一次研究访问是在2017年10月和11月，参与者随访了27个月。我们报告了入组后24个月的护理保留、病毒载量完成和病毒抑制（<400拷贝/mL），并使用AC聚类的广义估计方程计算了主要结局的意向治疗风险差异。在纳入试验的2150名受试者中，977名被分配到干预组（40名AC），1173名被分配到SoC组（48名AC）。各组入组时的患者特征相似。两组24个月时的护理保留率相似：SoC组为93.6%（1098/1173），干预组为92.6%（905/977），风险差异为-1.0%（95%CI：-3.2至1.3）。干预组的病毒载量完成率更高（90.8%（999/1173）vs 85.1%（887/977））和抑制（87.3%（969 /1173）vs. 82.6%（853/977）），完成风险差异为5.5%（95% CI：1.5至9.5）和抑制4.6%（95% CI：0.2至9.0）。接受6个月ART再填充的干预AC患者显示出非劣效于SoC AC患者的护理保留、病毒载量完成和病毒载量抑制，增加了越来越多的文献，显示延长ART分发间隔的良好结局。
The antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients’ retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non‐inferiority cluster randomized trial comparing standard of care (SoC) ACs and six‐month refill intervention ACs in a primary care facility in Khayelitsha, South Africa. Existing community‐based and facility‐based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two‐month refills with a four‐month refill over year‐end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six‐month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention‐to‐treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC. Of 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of −1.0% (95% CI: −3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0). Intervention AC patients receiving six‐month ART refills showed non‐inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.
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影响因子：
3.7
作者：
Luque-Fernandez, Miguel Angel;Van Cutsem, Gilles;Boulle, Andrew
通讯作者：
Boulle, Andrew
DOI：
10.1097/qai.0000000000001730
发表时间：
2018-08-15
影响因子：
3.6
作者：
Kim, Maria H.;Wanless, Richard S.;Abrams, Elaine J.
通讯作者：
Abrams, Elaine J.
优化乌干达社区抗逆转录病毒治疗项目临床效率的策略。
影响因子：
4.4
作者：
Alamo, Stella T.;Wagner, Glenn J.;Ouma, Joseph;Sunday, Pamela;Marie, Laga;Colebunders, Robert;Wabwire-Mangen, Fred
通讯作者：
Wabwire-Mangen, Fred
影响因子：
6
作者：
Kehoe, Kathleen;Boulle, Andrew;Cornell, Morna
通讯作者：
Cornell, Morna
影响因子：
2.5
作者：
Hoffman, Risa;Bardon, Ashley;Sanne, Ian
通讯作者：
Sanne, Ian