Helse Nord Tuberculosis Initiative, Department of Pathology, Kamuzu University of Health Sciences, Blantyre, Malawi.
Department of Global Health, Amsterdam UMC, Location University of Amsterdam, Amsterdam Institute for Global Health and Development, Meibergdreef 9, Amsterdam, the Netherlands.
Trials. 2023 Aug 15;24(1):535. doi: 10.1186/s13063-023-07496-6.
BACKGROUND: People living with HIV (PLHIV) have to take lifelong antiretroviral treatment, which is often challenging. Young people living with HIV (YPLHIV) have the lowest viral load suppression rates in Malawi and globally, mostly due to poor treatment adherence. This is a result of complex interactions of multiple factors unique to this demographic group. The use of digital health interventions, such as real-time medication monitor (RTMM)-based digital adherence tools (DATs), could improve ART adherence in YPLHIV and subsequently improve viral load suppression which in turn could lead to reduced HIV-associated morbidity and mortality. AIM: To provide the evidence base for a digital adherence intervention to improve treatment outcomes in YPLHIV on ART. OBJECTIVES: 1. The primary objective is to determine the efficacy of a customised DAT compared to the standard of care in improving ART adherence in YPLHIV. 2. The secondary objective is to determine the efficacy of the customised DAT compared to the standard of care in improving viral load suppression in YPLHIV. METHODOLOGY: This will be a parallel open-label randomised control controlled two-arm trial in which non-adherent YPLHIV in selected ART facilities in Blantyre will be randomised in a 1:1 ratio to a customised DAT and standard care arms and followed up for 9 months. The primary outcome is the proportion adherent at 9 months (> = 95% by pill count), and the secondary outcome is the proportion with viral load suppressed at 9 months (< 200 copies/ml). DISCUSSION: There is a paucity of good quality evidence on effective digital health interventions to improve ART adherence and viral load suppression in YPLHIV globally and particularly in HIV high-burden settings like Malawi. This study will provide good-quality evidence on the effectiveness of a customised DAT in improving ART adherence and viral load suppression in this important demographic. TRIAL REGISTRATION: The trial has been registered in the Pan African Clinical Trials Registry number: PACTR202303867267716 on 23 March 2023 and can be accessed through the following URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25424 . All items from the WHO Trial Registration Data Set are described in this manuscript.
背景：艾滋病毒感染者（PLHIV）需要终身接受抗逆转录病毒治疗，这往往具有挑战性。马拉维乃至全球的年轻艾滋病毒感染者（YPLHIV）的病毒载量抑制率最低，主要原因是治疗依从性差。这是由于该人群特有的多种因素的复杂相互作用所致。使用数字健康干预措施，如基于实时药物监测（RTMM）的数字依从性工具（DAT），可以提高 YPLHIV 的抗逆转录病毒治疗依从性，从而提高病毒载量抑制率，进而降低与 HIV 相关的发病率和死亡率。 目的：为改善接受抗逆转录病毒治疗的 YPLHIV 的治疗结果提供数字依从性干预措施的证据基础。 目标：1. 主要目标是确定与标准护理相比，定制 DAT 在提高 YPLHIV 抗逆转录病毒治疗依从性方面的疗效。2. 次要目标是确定与标准护理相比，定制 DAT 在提高 YPLHIV 病毒载量抑制方面的疗效。 方法：这将是一项在 Blantyre 选定的抗逆转录病毒治疗设施中，对非依从性 YPLHIV 进行的平行开放标签随机对照两臂试验，将他们以 1:1 的比例随机分配到定制 DAT 和标准护理组，并随访 9 个月。主要结局是 9 个月时的依从率（通过药片计数>95%），次要结局是 9 个月时的病毒载量抑制率（<200 拷贝/ml）。 讨论：全球范围内，特别是在像马拉维这样的 HIV 负担沉重的环境中，关于有效数字健康干预措施以提高 YPLHIV 的抗逆转录病毒治疗依从性和病毒载量抑制的高质量证据很少。这项研究将提供关于定制 DAT 提高这一重要人群的抗逆转录病毒治疗依从性和病毒载量抑制的有效性的高质量证据。 试验注册：该试验于 2023 年 3 月 23 日在泛非临床试验注册中心注册，注册号为：PACTR202303867267716，可通过以下网址访问：https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25424。本研究描述了世界卫生组织试验注册数据集的所有项目。
J Acquir Immune Defic Syndr. 2019-11-1
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