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莱索托稳定感染 HIV 的成年人中基于社区的多剂量 ART 差异化模式的 12 个月结局:一项集群随机非劣效性试验。

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.

机构信息

Right to Care/EQUIP Health, Maseru, Lesotho.

Kheth'Impilo AIDS Free Living, Cape Town, South Africa.

出版信息

J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):280-291. doi: 10.1097/QAI.0000000000002439.


DOI:10.1097/QAI.0000000000002439
PMID:32665460
Abstract

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.

摘要

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。

相似文献

[1]
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.

J Acquir Immune Defic Syndr. 2020-11-1

[2]
Outcomes of Three- Versus Six-Monthly Dispensing of Antiretroviral Treatment (ART) for Stable HIV Patients in Community ART Refill Groups: A Cluster-Randomized Trial in Zimbabwe.

J Acquir Immune Defic Syndr. 2020-6-1

[3]
Economic evaluation of differentiated service delivery models for HIV treatment in Lesotho: costs to providers and patients.

J Int AIDS Soc. 2021-4

[4]
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.

J Int AIDS Soc. 2021-10

[5]
Out-of-Facility Multimonth Dispensing of Antiretroviral Treatment: A Pooled Analysis Using Individual Patient Data From Cluster-Randomized Trials in Southern Africa.

J Acquir Immune Defic Syndr. 2021-12-15

[6]
Outcomes of community-based differentiated models of multi-month dispensing of antiretroviral medication among stable HIV-infected patients in Lesotho: a cluster randomised non-inferiority trial protocol.

BMC Public Health. 2018-8-29

[7]
The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial.

Trials. 2018-1-29

[8]
Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial.

Trials. 2017-10-13

[9]
VIBRA trial - Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho.

Trials. 2019-8-22

[10]
Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial.

JAMA. 2018-3-20

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[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[9]
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[10]
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