社区 ART 续药组中稳定 HIV 患者每 3 个月与 6 个月发放抗逆转录病毒治疗药物（ART）的结局比较：津巴布韦的一项集群随机试验。
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.
机构信息
Kheth'Impilo AIDS Free Living, Cape Town, South Africa.
Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
出版信息
J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):162-172. doi: 10.1097/QAI.0000000000002333.
INTRODUCTION
Multimonth dispensing (MMD) of antiretroviral treatment (ART) aims to reduce patient-related barriers to access long-term treatment and improve health system efficiency. However, randomized evidence of its clinical effectiveness is lacking. We compared MMD within community ART refill groups (CARGs) vs. standard-of-care facility-based ART delivery in Zimbabwe.
METHODS
A three-arm, cluster-randomized, pragmatic noninferiority trial was performed. Thirty health care facilities and associated CARGs were allocated to either ART collected three-monthly at facility (3MF, control); ART delivered three-monthly in CARGs (3MC); or ART delivered six-monthly in CARGs (6MC). Stable adults receiving ART ≥six months with baseline viral load (VL) <1000 copies/ml were eligible. Retention in ART care (primary outcome) and viral suppression (VS) 12 months after enrollment were compared, using regression models specified for clustering (ClinicalTrials.gov: NCT03238846).
RESULTS
4800 participants were recruited, 1919, 1335, and 1546 in arms 3MF, 3MC, and 6MC, respectively. For retention, the prespecified noninferiority limit (-3.25%, risk difference [RD]) was met for comparisons between all arms, 3MC (94.8%) vs. 3MF (93.0%), adjusted RD = 1.1% (95% CI: -0.5% to 2.8%); 6MC (95.5%) vs. 3MF: aRD = 1.2% (95% CI: -1.0% to 3.6%); and 6MC vs. 3MC: aRD = 0.1% (95% CI: -2.4% to 2.6%). VL completion at 12 months was 49%, 45%, and 8% in 3MF, 3MC, and 6MC, respectively. VS in 3MC (99.7%) was high and not different to 3MF (99.1%), relative risk = 1.0 (95% CI: 1.0-1.0). VS was marginally reduced in 6MC (92.9%) vs. 3MF, relative risk = 0.9 (95% CI: 0.9-1.0).
CONCLUSION
Retention in CARGs receiving three- and six-monthly MMD was noninferior versus standard-of-care facility-based ART delivery. VS in 3MC was high. VS in six-monthly CARGs requires further evaluation.
简介
多月份配药（MMD）的抗逆转录病毒治疗（ART）旨在减少患者获得长期治疗的相关障碍，并提高卫生系统的效率。然而，缺乏关于其临床效果的随机证据。我们比较了津巴布韦社区 ART refill 组（CARGs）内 MMD 与基于标准护理的医疗机构提供的 ART 之间的差异。
方法
采用三臂、聚类随机、实用非劣效性试验。将 30 个医疗保健设施和相关的 CARGs 分配到以下三组：在医疗机构每三个月收集一次 ART（3MF，对照组）；在 CARGs 中每三个月提供一次 ART（3MC）；或在 CARGs 中每六个月提供一次 ART（6MC）。基线病毒载量（VL）<1000 拷贝/ml 且接受 ART 治疗≥6 个月的稳定成人符合条件。使用指定为聚类的回归模型（ClinicalTrials.gov：NCT03238846）比较 ART 护理的保留率（主要结局）和 12 个月后的病毒抑制（VS）。
结果
共招募了 4800 名参与者，分别为 3MF、3MC 和 6MC 组的 1919、1335 和 1546 名。对于保留率，所有组之间的预设非劣效性界限（-3.25%，风险差异[RD]）均达到，3MC（94.8%）与 3MF（93.0%）相比，调整后的 RD = 1.1%（95%CI：-0.5%至 2.8%）；6MC（95.5%）与 3MF：aRD = 1.2%（95%CI：-1.0%至 3.6%）；6MC 与 3MC：aRD = 0.1%（95%CI：-2.4%至 2.6%）。VL 在 12 个月时的完成率分别为 3MF 的 49%、3MC 的 45%和 6MC 的 8%。3MC 的 VS 为 99.7%，与 3MF 相似，相对风险=1.0（95%CI：1.0-1.0）。6MC 中 VS 略有下降（92.9%），与 3MF 相比，相对风险=0.9（95%CI：0.9-1.0）。
结论
在接受三至六个月 MMD 的 CARGs 中，保留率不劣于基于标准护理的医疗机构提供的 ART。3MC 中的 VS 较高。需要进一步评估 6MC 中每六个月的 VS。
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