Zambart, Lusaka, Zambia.
Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
Lancet HIV. 2022 Jan;9(1):e13-e23. doi: 10.1016/S2352-3018(21)00242-3. Epub 2021 Nov 26.
BACKGROUND: Non-facility-based antiretroviral therapy (ART) delivery for people with stable HIV might increase sustainable ART coverage in low-income and middle-income countries. Within the HPTN 071 (PopART) trial, two interventions, home-based delivery (HBD) and adherence clubs (AC), which included groups of 15-30 participants who met at a communal venue, were compared with standard of care (SoC). In this trial we looked at the effectiveness and feasibility of these alternative models of care. Specifically, this trial aimed to assess whether these models of care had similar virological suppression to that of SoC 12 months after enrolment. METHODS: This was a three-arm, cluster-randomised, non-inferiority trial, done in two urban communities in Lusaka, Zambia included in the HPTN 071 trial. The two communities were split into zones, which were randomly assigned (1:1:1) to the three treatment strategies: 35 zones to the SoC group, 35 zones to the HBD group, and 34 zones to the AC group. ART and adherence support were delivered once every 3 months at home for the HBD group, in groups of 15-30 people in the AC group, or in the clinic for the SoC group. Adults with HIV who were receiving first-line ART for at least 6 months, virally suppressed using national HIV guidelines in the last 12 months, had no other health conditions requiring the clinicians attention, live in the study catchment area, and provided written informed consent, were eligible for inclusion. The primary endpoint was viral suppression at 12 months (with a 6 month final measurement window [ie, 9-15 months]), defined as less than 1000 HIV RNA copies per mL, with a non-inferiority margin of 5%. FINDINGS: Between May 5 and Dec 19, 2017, 9900 individuals were screened for inclusion, of whom 2489 (25·1%) participants were enrolled into the trial: 781 (31%) in the SoC group, 852 (34%) in the HBD group, and 856 (34%) in the AC group. A higher proportion of participants had viral load measurements in the primary outcome window in the HBD (581 [61%]of 852 participants) and AC (485 [57%] of 856 participants) groups than in the SoC (390 [50%] of 781 patients) group (p=0·0021). Of the 1096 missing observations, 152 (13·8%) were attributable to either deaths (25 [16%] participants), relocations (37 [24%] participants), or lost to follow-up (90 [59%]); 690 (63·0%) participants had viral load results outside the window period; and 254 (23·2%) did not have a viral load result. The prevalence of viral suppression was estimated to be 98·3% (95% CI 96·6 to 99·7) in the SoC group, 98·7% (97·5 to 99·6) in the HBD group, and 99·2% (98·4 to 99·8) in the AC group. This gave an estimated risk difference of 0·3% (95% CI -1·5 to 2·4) for the HBD group compared with the SoC group and 0·9% (-0·8 to 2·8) for the AC group compared with the SoC group. There was strong evidence (p<0·0001) that both community ART models were non-inferior to the SoC group (p<0·0001). INTERPRETATION: Community models of ART delivery were as effective as facility-based care in terms of viral suppression. FUNDING: National Institute of Allergy and Infectious Diseases, The International Initiative for Impact Evaluation (3ie), the Bill & Melinda Gates Foundation, National Institute on Drug Abuse, National Institute of Mental Health, and President's Emergency Plan for AIDS Relief.
背景:对于 HIV 稳定的人来说,非机构为基础的抗逆转录病毒治疗(ART)可能会增加低收入和中等收入国家可持续的 ART 覆盖率。在 HPTN 071(PopART)试验中,与标准护理(SoC)相比,两种干预措施,即家庭为基础的治疗(HBD)和依从俱乐部(AC),都进行了比较,其中 HBD 包括在一个共同场所会面的 15-30 名参与者的小组,而 AC 则包括 15-30 名参与者的小组。在这项试验中,我们研究了这些替代护理模式的有效性和可行性。具体来说,本试验旨在评估这些护理模式在纳入后 12 个月时是否具有与 SoC 相似的病毒抑制效果。
方法:这是一项在赞比亚卢萨卡两个城市社区进行的、三臂、集群随机、非劣效性试验,该试验纳入了 HPTN 071 试验。这两个社区被分为区域,这些区域被随机分配(1:1:1)至三种治疗策略:35 个区域至 SoC 组,35 个区域至 HBD 组,34 个区域至 AC 组。对于 HBD 组,ART 和依从性支持每 3 个月在家庭中提供一次,对于 AC 组,以 15-30 人的小组形式在群体中提供,对于 SoC 组,则在诊所提供。在过去 12 个月中使用国家 HIV 指南病毒得到抑制、没有其他需要临床医生关注的健康状况、居住在研究范围内、并提供书面知情同意书的 HIV 感染者,有资格入组。主要终点是 12 个月时的病毒抑制(有 6 个月的最终测量窗口[即 9-15 个月]),定义为少于 1000 HIV RNA 拷贝/毫升,非劣效性边界为 5%。
结果:在 2017 年 5 月 5 日至 12 月 19 日期间,共有 9900 人接受了入组筛选,其中 2489 人(25.1%)参加了试验:SoC 组 781 人(31%),HBD 组 852 人(34%),AC 组 856 人(34%)。在主要结局窗口中,HBD(61%,852 名参与者中有 581 名)和 AC(57%,856 名参与者中有 485 名)组中,有更多的参与者进行了病毒载量测量,而 SoC 组(50%,781 名患者中有 390 名)的参与者则较少(p=0.0021)。在 1096 个缺失观察值中,有 152 个(13.8%)归因于死亡(25 名[16%]参与者)、搬迁(37 名[24%]参与者)或失访(90 名[59%]参与者);690 名(63.0%)参与者的病毒载量结果超出了窗口期;254 名(23.2%)没有病毒载量结果。估计 SoC 组的病毒抑制率为 98.3%(95%CI 96.6 至 99.7),HBD 组为 98.7%(97.5 至 99.6),AC 组为 99.2%(98.4 至 99.8)。这意味着 HBD 组与 SoC 组相比,估计风险差异为 0.3%(95%CI-1.5 至 2.4),AC 组与 SoC 组相比,估计风险差异为 0.9%(-0.8 至 2.8)。有强有力的证据(p<0.0001)表明,这两种社区 ART 模式都与 SoC 组一样有效(p<0.0001)。
解释:在病毒抑制方面,社区提供的 ART 治疗模式与基于机构的护理一样有效。
资金:美国国立过敏和传染病研究所、国际影响评估倡议(3ie)、比尔及梅琳达盖茨基金会、美国国立药物滥用研究所、美国国立精神卫生研究所和总统艾滋病紧急救援计划。
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