Right to Care/EQUIP Health, Maseru, Lesotho.
Kheth'Impilo AIDS Free Living, Cape Town, South Africa.
J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):280-291. doi: 10.1097/QAI.0000000000002439.
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.
背景:莱索托于 2016 年 6 月采用了检测和治疗的 HIV 治疗方法,这增加了抗逆转录病毒治疗(ART)诊所的数量。我们评估了莱索托稳定感染 HIV 的成年人中基于社区和基于机构的不同的 ART 多剂量分发模式。
方法:30 个机构被随机分为 3 组,机构 3 个月 ART(3MF)(对照组)、社区 ART 组(3MC)和 6 个月社区分发点(6MCD)。我们使用人群平均广义估计方程估计了各组之间的风险差异(RD),控制了基线不平衡,并指定了聚类。主要结局是按意向治疗进行 ART 护理的保留率,次要结局是病毒学抑制(ClinicalTrials.gov:NCT03438370)。
结果:共有 5336 名参与者入组,3MF、3MC 和 6MCD 组分别有 1898、1558 和 1880 名参与者。各组之间的 ART 护理保留率没有差异,并且在 3MC 与 3MF(对照组)、6MCD 与 3MF 和 6MCD 与 3MC 之间达到了预先指定的非劣效性界限(-3.25%),调整后的 RD = -0.1%(95%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%)。在 12 个月时,3MF、3MC 和 6MCD 组分别有 98.6%(n=1503)、98.1%(n=1126)和 98.3%(n=1285)的病毒载量(VL)得到抑制。3MC 与对照组和 6MCD 与对照组之间的 VL 无差异,风险比(RR)分别为 1.00(95%CI:0.98 至 1.01)和 RR = 1.00(95%CI:0.98 至 1.01)。
结论:在基于社区的差异化模型中,稳定感染 HIV 的参与者接受多剂量分发的 ART 治疗时,与基于机构的标准护理模型相比,在保留和 VL 抑制方面没有差异。