比较不同社区模式与标准护理在稳定 HIV+ 患者中的抗逆转录病毒治疗效果：一项非劣效性集群随机试验的原理和设计，嵌套在 HPTN 071（PopART）研究中。
A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study.
机构信息
Zambart, University of Zambia, School of Medicine, Zambart House, Ridgeway Campus, Off Nationalist Road, P.O. Box 50697, Lusaka, Zambia.
Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
出版信息
Trials. 2021 Jan 12;22(1):52. doi: 10.1186/s13063-020-05010-w.
BACKGROUND
Following the World Health Organization's (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges.
METHODS
A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as "stable" on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data.
DISCUSSION
This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03025165 . Registered on 19 January 2017.
背景
世界卫生组织（WHO）于 2015 年发布指南，建议所有艾滋病毒感染者（PLHIV）无论 CD4 计数如何，均应开始接受抗逆转录病毒治疗（ART），此后，撒哈拉以南非洲的许多国家已采用该策略来控制艾滋病疫情。随着接受 ART 的 PLHIV 人数增加，在资源有限且 HIV 负担沉重的环境中，如何确保 90%以上的 PLHIV 维持 ART 治疗病毒抑制，仍是政府卫生系统面临的挑战。为稳定的 HIV+患者提供非医疗机构提供的抗逆转录病毒治疗（ART）可能会增加资源有限地区可持续的 ART 覆盖率。在 HPTN 071（PopART）试验中，提供了两种模式，即家庭提供（HBD）或遵医嘱俱乐部（AC），以评估它们是否能达到与标准护理（SoC）相似的病毒载量抑制（VLS）。在本文中，我们将描述试验设计，并讨论方法学问题和挑战。
方法
这是一项三臂、集群随机、非劣效性试验，嵌套在赞比亚两个城市的 HPTN 071 试验社区中，将 104 个区随机分配到 SoC（35 个）、HBD（35 个）或 AC（34 个）。ART 和依从性支持每 3 个月在家中（HBD）、遵医嘱俱乐部（AC）或诊所（SoC）提供。符合 ART“稳定”条件的成年 HIV+患者有资格入选。主要终点是所有 3 个组在研究入组后 12 个月（±3 个月）时病毒载量抑制（<1000 拷贝 HIV RNA/ml）的 PLHIV 比例。病毒载量测量按照国家指南在常规政府实验室进行，每年进行一次。该研究的目的是确定这两种基于社区的干预措施是否会导致病毒抑制率比 SoC 下降超过 5%，降幅绝对值不超过 5%。这两种基于社区的干预措施均由社区 HIV 提供者（CHiPs）提供。在这项研究中嵌套了一项额外的定性研究，使用观察、与 PLHIV 的访谈以及与社区 HIV 提供者的焦点小组讨论，以补充定量数据。
讨论
本试验旨在为资源有限、HIV 负担沉重地区为稳定的 PLHIV 提供非医疗机构提供 ART 的安全性和疗效提供严格的随机证据。该试验将为最佳实践的政策制定提供信息，并为加强资源有限地区差异化 ART 提供模式提供所需的支持。
试验注册
ClinicalTrials.gov NCT03025165，于 2017 年 1 月 19 日注册。
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