Twelve-Month Outcomes of Community-Based Differentiated Models of Multimonth Dispensing of ART Among Stable HIV-Infected Adults in Lesotho: A Cluster-Randomized Noninferiority Trial
Twelve-Month Outcomes of Community-Based Differentiated Models of Multimonth Dispensing of ART Among Stable HIV-Infected Adults in Lesotho: A Cluster-Randomized Noninferiority Trial
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DOI：
10.1097/qai.0000000000002439
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发表时间：
2020-11-01
影响因子：
3.6
通讯作者：
Chasela, Charles
中科院分区：
文献类型：
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作者：
Tukei, Betty B.;Fatti, Geoffrey;Chasela, Charles
背景：莱索托于 2016 年 6 月采用了艾滋病毒治疗的“检测与治疗”方法，增加了抗逆转录病毒治疗（ART）的诊所数量。我们评估了莱索托稳定的艾滋病毒感染成年人中基于社区和基于设施的多月抗逆转录病毒治疗的差异化模型。方法：将 30 个设施随机分为 3 个组，设施为每 3 个月 ART (3MF)（对照）、社区 ART 组 (3MC) 和每 6 个月社区分发点 (6MCD)。我们使用人口平均广义估计方程估计各组之间的风险差异 (RD)，控制基线不平衡并指定聚类。主要结局是通过意向治疗和病毒学抑制作为次要结局保留 ART 护理（ClinicalTrials.gov：NCT03438370）。结果：共有 5,336 名参与者入组，其中 3MF、3MC 和 6MCD 分别为 1898、1558 和 1880 名。 ART 治疗的保留率在各组之间没有差异，并且在 3MC 与 3MF（对照）之间达到了预先指定的非劣效性极限 (-3.25%)； 6MCD 与 3MF；和 6MCD 与 3MC 相比，调整后的 RD = -0.1% [95% 置信区间 (CI)：-1.6% 至 1.5%]、调整后的 RD = -1.3%（95% CI：-3.0% 至 0.5%）和调整后的 RD = -1.2%（95% CI：-2.9% 至 0.5%）。 12 个月后，3MF、3MC 和 6MCD 中的病毒载量 (VL) 分别得到抑制，分别为 98.6% (n = 1503)、98.1% (n = 1126) 和 98.3% (n = 1285)。 3MC 与对照和 6MCD 与对照之间的 VL 没有差异，风险比 (RR) = 1.00（95% CI：0.98 至 1.01）和 RR = 1.00（95% CI：0.98 至 1.01）。结论：与基于机构的标准护理模型相比，在基于社区的差异化模型中接受数月 ART 配药的稳定 HIV 感染者的保留和 VL 抑制没有差异。
Background: Lesotho adopted the test-and-treat approach for HIV treatment in June 2016, which increased antiretroviral treatment (ART) clinic volume. We evaluated community-based vs. facility-based differentiated models of multimonth dispensing of ART among stable HIV-infected adults in Lesotho. Methods: Thirty facilities were randomized to 3 arms, facility 3-monthly ART (3MF) (control), community ART groups (3MC), and 6-monthly community distribution points (6MCD). We estimated risk differences (RDs) between arms using population-averaged generalized estimating equations, controlling for baseline imbalances and specifying for clustering. The primary outcome was retention in ART care by intention-to-treat and virologic suppression as a secondary outcome (ClinicalTrials.gov: NCT03438370). Results: A total of 5,336 participants were enrolled, with 1898, 1558, and 1880 in 3MF, 3MC, and 6MCD, respectively. Retention in ART care was not different across arms and achieved the prespecified noninferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD = -0.1% [95% confidence interval (CI): -1.6% to 1.5%], adjusted RD = -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD = -1.2% (95% CI: -2.9% to 0.5%), respectively. After 12 months, 98.6% (n = 1503), 98.1% (n = 1126), and 98.3% (n = 1285) were virally load (VL) suppressed in 3MF, 3MC, and 6MCD, respectively. There were no differences in VL between 3MC vs. control and 6MCD vs. control, risk ratio (RR) = 1.00 (95% CI: 0.98 to 1.01) and RR = 1.00 (95% CI: 0.98 to 1.01), respectively. Conclusions: There were no differences in retention and VL suppression for stable HIV-infected participants receiving multimonth dispensing of ART within community-based differentiated models when compared with the facility-based standard-of-care model.