Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial
Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial
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DOI：
10.1016/s2214-109x(21)00039-5
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发表时间：
2021-05-01
影响因子：
34.3
通讯作者：
Rosen, Sydney
中科院分区：
文献类型：
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作者：
Hoffman, Risa M.;Moyo, Crispin;Rosen, Sydney
以机构为基础的艾滋病毒抗逆转录病毒治疗（ART）的数月分发可以减轻患者和提供者的负担，并提高护理的保留率。我们评估是否6个月的ART配药是非劣效于标准的护理和3个月的ART dispensation.Methods我们做了一个务实的，集群随机，非盲，非劣效性试验（INTERVAL）在马拉维和赞比亚的30个卫生设施。符合条件的参与者年龄在18岁或以上，HIV阳性，并且在ART治疗中临床稳定。在随机化之前，根据国家，ART队列规模，设施类型（即医院与卫生中心）以及地区或省份匹配卫生设施（集群）。使用简单的随机分配序列，将匹配的群组随机分配（1：1：1）到标准护理、3个月ART分发或6个月ART分发。主要结果是在12个月时保持护理，定义为在研究随访期间连续60天内未接受ART的患者比例，通过意向治疗进行分析。使用2.5%的边界评估非劣效性。该研究在www.example.com注册ClinicalTrials.gov，NCT 03101592。结果在2017年5月15日至2018年4月30日期间，随机分配了9118名参与者，其中8719名参与者（n=3012，标准护理组; n=2726，3个月ART分发组; n=2981，6个月ART分发组）在12个月时有主要结局数据，并被纳入主要分析。参与者的中位年龄为42.7岁（IQR 36.1-49.9），8719人中有5774人（66.2%）为女性。标准治疗组3012名参与者中有2478名（82.3%）达到主要结局，3个月ART分发组2726名参与者中有2356名（86.4%）达到主要结局，6个月ART分发组2981名参与者中有2729名（91.5%）达到主要结局。在对聚类进行调整后，对于12个月时的护理保留，6个月ART分发组不劣于标准护理组（治疗点增加9.1 [95% CI 0.9-17.2]）和3个月ART分发组解释每6个月进行一次抗逆转录病毒治疗的临床访视不劣于标准治疗和每3个月进行一次抗逆转录病毒治疗。6-在资源有限的情况下，每月发放抗逆转录病毒药物是扩大抗逆转录病毒药物供应和实现艾滋病毒治疗目标的一项有希望的战略。版权所有（C）2021作者。由Elsevier Ltd.出版，这是一篇开放获取文章，CC BY-NC-ND 4.0许可证。
Background Facility-based, multimonth dispensing of antiretroviral therapy (ART) for HIV could reduce burdens on patients and providers and improve retention in care. We assessed whether 6-monthly ART dispensing was non-inferior to standard of care and 3-monthly ART dispensing.Methods We did a pragmatic, cluster-randomised, unblinded, non-inferiority trial (INTERVAL) at 30 health facilities in Malawi and Zambia. Eligible participants were aged 18 years or older, HIV-positive, and were clinically stable on ART. Before randomisation, health facilities (clusters) were matched on the basis of country, ART cohort size, facility type (ie, hospital vs health centre), and region or province. Matched clusters were randomly allocated (1:1:1) to standard of care, 3-monthly ART dispensing, or 6-monthly ART dispensing using a simple random allocation sequence. The primary outcome was retention in care at 12 months, defined as the proportion of patients with less than 60 consecutive days without ART during study follow-up, analysed by intention to treat. A 2.5% margin was used to assess noninferiority. This study is registered with ClinicalTrials.gov, NCT03101592.Findings Between May 15, 2017, and April 30, 2018, 9118 participants were randomly assigned, of whom 8719 participants (n=3012, standard of care group; n=2726, 3-monthly ART dispensing group; n=2981, 6-monthly ART dispensing group) had primary outcome data available at 12 months and were included in the primary analysis. The median age of participants was 42.7 years (IQR 36.1-49.9) and 5774 (66.2%) of 8719 were women. The primary outcome was met by 2478 (82.3%) of 3012 participants in the standard of care group, 2356 (86.4%) of 2726 participants in the 3-monthly ART dispensing group, and 2729 (91.5%) of 2981 participants in the 6-monthly ART dispensing group. After adjusting for clustering, for retention in care at 12 months, the 6-monthly ART dispensing group was non-inferior to the standard of care group (percentage-point increase 9.1 [95% CI 0.9-17.2]) and to the 3-monthly ART dispensing group (5.0% [1.0-9.1]).Interpretation Clinical visits with ART dispensing every 6 months was non-inferior to standard of care and 3-monthly ART dispensing. 6-monthly ART dispensing is a promising strategy for the expansion of ART provision and achievement of HIV treatment targets in resource-constrained settings. Copyright (C) 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license.