Department of Medicine, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA, USA.
Right to Care Zambia, Lusaka, Zambia.
Lancet Glob Health. 2021 May;9(5):e628-e638. doi: 10.1016/S2214-109X(21)00039-5.
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.
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 non-inferiority. This study is registered with ClinicalTrials.gov, NCT03101592.
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]).
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.
US Agency for International Development.
在医疗机构中，每 6 个月发放一次抗逆转录病毒疗法（ART）药物，这可以减少患者和医疗服务提供者的负担，并提高患者的治疗保留率。我们评估了每 6 个月发放一次 ART 是否不劣于标准护理和每 3 个月发放一次 ART。
我们在马拉维和赞比亚的 30 个卫生机构进行了一项实用的、基于群组的、非盲的、非劣效性试验（INTERVAL）。符合条件的参与者年龄在 18 岁或以上，HIV 阳性，在接受 ART 治疗后临床状况稳定。在随机分组之前，根据国家、ART 队列规模、机构类型（即医院与卫生中心）以及地区或省份对卫生机构（群组）进行匹配。使用简单随机分配序列将匹配的群组（1:1:1）随机分配到标准护理组、每 3 个月 ART 分配组或每 6 个月 ART 分配组。主要结局是在 12 个月时的治疗保留率，定义为研究随访期间，少于 60 天连续未接受 ART 的患者比例，采用意向治疗分析。使用 2.5%的差值来评估非劣效性。这项研究在 ClinicalTrials.gov 注册，编号为 NCT03101592。
在 2017 年 5 月 15 日至 2018 年 4 月 30 日期间，共有 9118 名参与者被随机分配，其中 8719 名参与者（n=3012，标准护理组；n=2726，3 个月 ART 分配组；n=2981，6 个月 ART 分配组）在 12 个月时有主要结局数据，并纳入了主要分析。参与者的中位年龄为 42.7 岁（IQR 36.1-49.9），8719 名参与者中 5774 名（66.2%）为女性。标准护理组中 2478 名（82.3%）、3 个月 ART 分配组中 2356 名（86.4%）和 6 个月 ART 分配组中 2729 名（91.5%）参与者达到了主要结局。在调整聚类效应后，12 个月时的治疗保留率，6 个月 ART 分配组不劣于标准护理组（百分点增加 9.1[95%CI 0.9-17.2]）和 3 个月 ART 分配组（5.0%[1.0-9.1]）。
每 6 个月进行一次 ART 药物发放的临床访视不劣于标准护理和每 3 个月 ART 分配。每 6 个月 ART 分配是在资源有限的环境中扩大 ART 供应和实现 HIV 治疗目标的有前途的策略。
美国国际开发署。
