Community-based differentiated service delivery models incorporating multi-month dispensing of antiretroviral treatment for newly stable people living with HIV receiving single annual clinical visits: a pooled analysis of two cluster-randomized trials in southern Africa.
Community-based differentiated service delivery models incorporating multi-month dispensing of antiretroviral treatment for newly stable people living with HIV receiving single annual clinical visits: a pooled analysis of two cluster-randomized trials in southern Africa.
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DOI：
10.1002/jia2.25819
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发表时间：
2021-10
影响因子：
6
通讯作者：
Grimwood A
中科院分区：
文献类型：
--
作者：
Fatti G;Ngorima-Mabhena N;Tiam A;Tukei BB;Kasu T;Muzenda T;Maile K;Lombard C;Chasela C;Grimwood A
艾滋病毒治疗的差异化服务提供（DSD）模式减少了卫生机构就诊频率，并限制了卫生机构对严重急性呼吸综合征冠状病毒的暴露2。然而，两个重要的证据差距包括了解在抗逆转录病毒治疗（ART）开始12个月内开始DSD的客户以及仅接受一次年度临床咨询的客户的DSD有效性。为了研究这些问题，我们汇集了来自津巴布韦和莱索托两项调查基于社区的DSD的集群随机试验的数据。在抗逆转录病毒治疗开始后6至12个月间入组的新稳定成人的个人水平参与者数据进行汇总。两项试验（在2017年8月至2019年7月期间进行）都有三个组：在医疗机构每月提供三个月的标准护理ART （SoC，对照组）；ART在社区ART组（CAGs） （3MC）每月提供3次，ART在社区ART组或社区分发点（6MC）每月提供6次。SoC组为每月3次，干预组为每年一次。主要结局是保留护理，次要结局是病毒抑制（VS）和入组后12个月计划外的设施访问次数。个体水平的回归分析通过意向处理指定聚类，并根据国家进行调整。共纳入599名参与者；SoC、3MC和6MC分别为212（35.4%）、128（21.4%）和259（43.2%）。很少有年龄<25岁的参与者被纳入（n = 32）。12个月后，SoC、3MC和6MC分别保留198（93.4%）、123（96.1%）和248（95.8%）。3MC组的保留率优于SoC组，调整后的风险差(aRD) = 4.6% （95% CI: 0.7% - 8.5%）。与SoC相比，6MC的保留率非劣效性，aRD = 1.7% (95% CI: - 2.5% - 5.9%)（预先指定的非劣效性aRD边际- 3.25%）。各组间VS相似，SoC、3MC和6MC的VS分别为99.3%、98.6%和98.1%。3MC与SoC的VS校正风险比为0.98 (95% CI: 0.92 - 1.03)， 6MC与SoC的VS校正风险比为0.98 （95% CI: 0.95 - 1.00）。干预组未安排的门诊就诊未增加：3MC与SoC的发生率比= 0.53 (CI: 0.16 - 1.80)；6MC与SoC的比值为0.82 （CI: 0.25−2.79）。在年龄≥25岁的新稳定的ART患者中，以社区为基础的DSD包括3个月和6个月的ART补充和每年一次的临床就诊，至少不逊色于标准的基于设施的护理。ClinicalTrials.gov: NCT03238846和NCT03438370
Differentiated service delivery (DSD) models for HIV treatment decrease health facility visit frequency and limit healthcare facility‐based exposure to severe acute respiratory syndrome coronavirus 2. However, two important evidence gaps include understanding DSD effectiveness amongst clients commencing DSD within 12 months of antiretroviral treatment (ART) initiation and amongst clients receiving only single annual clinical consultations. To investigate these, we pooled data from two cluster‐randomized trials investigating community‐based DSD in Zimbabwe and Lesotho. Individual‐level participant data of newly stable adults enrolled between 6 and 12 months after ART initiation were pooled. Both trials (conducted between August 2017 and July 2019) had three arms: Standard‐of‐care three‐monthly ART provision at healthcare facilities (SoC, control); ART provided three‐monthly in community ART groups (CAGs) (3MC) and ART provided six‐monthly in either CAGs or at community‐distribution points (6MC). Clinical visits were three‐monthly in SoC and annually in intervention arms. The primary outcome was retention in care and secondary outcomes were viral suppression (VS) and number of unscheduled facility visits 12 months after enrolment. Individual‐level regression analyses were conducted by intention‐to‐treat specifying for clustering and adjusted for country. A total of 599 participants were included; 212 (35.4%), 128 (21.4%) and 259 (43.2%) in SoC, 3MC and 6MC, respectively. Few participants aged <25 years were included (n = 32). After 12 months, 198 (93.4%), 123 (96.1%) and 248 (95.8%) were retained in SoC, 3MC and 6MC, respectively. Retention in 3MC was superior versus SoC, adjusted risk difference (aRD) = 4.6% (95% CI: 0.7%−8.5%). Retention in 6MC was non‐inferior versus SoC, aRD = 1.7% (95% CI: −2.5%−5.9%) (prespecified non‐inferiority aRD margin −3.25%). VS was similar between arms, 99.3, 98.6 and 98.1% in SoC, 3MC and 6MC, respectively. Adjusted risk ratio's for VS were 0.98 (95% CI: 0.92−1.03) for 3MC versus SoC, and 0.98 (CI: 0.95−1.00) for 6MC versus SoC. Unscheduled clinic visits were not increased in intervention arms: incidence rate ratio = 0.53 (CI: 0.16−1.80) for 3MC versus SoC; and 0.82 (CI: 0.25−2.79) for 6MC versus SoC. Community‐based DSD incorporating three‐ and six‐monthly ART refills and single annual clinical visits were at least non‐inferior to standard facility‐based care amongst newly stable ART clients aged ≥25 years. ClinicalTrials.gov: NCT03238846 & NCT03438370
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影响因子：
3.8
作者：
Hoffman, Risa M.;Balakasi, Kelvin;Rosen, Sydney
通讯作者：
Rosen, Sydney
影响因子：
6
作者：
Cassidy T;Grimsrud A;Keene C;Lebelo K;Hayes H;Orrell C;Zokufa N;Mutseyekwa T;Voget J;Gerstenhaber R;Wilkinson L
通讯作者：
Wilkinson L
影响因子：
4.5
作者：
Faturiyele, I. O.;Appolinare, T.;Pisa, P. T.
通讯作者：
Pisa, P. T.
影响因子：
3.7
作者：
Stewart GB;Altman DG;Askie LM;Duley L;Simmonds MC;Stewart LA
通讯作者：
Stewart LA
影响因子：
2.9
作者：
Ross J;Murenzi G;Hill S;Remera E;Ingabire C;Umwiza F;Munyaneza A;Muhoza B;Habimana DS;Mugwaneza P;Zhang C;Yotebieng M;Anastos K
通讯作者：
Anastos K