Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.
Trials. 2023 Apr 24;24(1):292. doi: 10.1186/s13063-023-07289-x.
BACKGROUND: Tuberculosis remains a leading infectious cause of death in resource-limited settings. Effective treatment is the cornerstone of tuberculosis control, reducing mortality, recurrence and transmission. Supporting treatment adherence through facility-based observations of medication taking can be costly to providers and patients. Digital adherence technologies (DATs) may facilitate treatment monitoring and differentiated care. The ASCENT-Ethiopia study is a three-arm cluster randomised trial assessing two DATs with differentiated care for supporting tuberculosis treatment adherence in Ethiopia. This study is part of the ASCENT consortium, assessing DATs in South Africa, the Philippines, Ukraine, Tanzania and Ethiopia. The aim of this study is to determine the costs, cost-effectiveness and equity impact of implementing DATs in Ethiopia. METHODS AND DESIGN: A total of 78 health facilities have been randomised (1:1:1) into one of two intervention arms or a standard-of-care arm. Approximately 50 participants from each health facility will be enrolled on the trial. Participants in facilities randomised to the intervention arms are offered a DAT linked to the ASCENT adherence platform for daily adherence monitoring and differentiated response for those who have missed doses. Participants at standard-of-care facilities receive routine care. Treatment outcomes and resource utilisation will be measured for each participant. The primary effectiveness outcome is a composite index of unfavourable end-of-treatment outcomes (lost to follow-up, death or treatment failure) or treatment recurrence within 6 months of end-of-treatment. For the cost-effectiveness analysis, end-of-treatment outcomes will be used to estimate disability-adjusted life years (DALYs) averted. Provider and patient cost data will be collected from a subsample of 5 health facilities per study arm, 10 participants per facility (n = 150). We will conduct a societal cost-effectiveness analysis using Bayesian hierarchical models that account for the individual-level correlation between costs and outcomes as well as intra-cluster correlation. An equity impact analysis will be conducted to summarise equity efficiency trade-offs. DISCUSSION: Trial enrolment is ongoing. This paper follows the published trial protocol and describes the protocol and analysis plan for the health economics work package of the ASCENT-Ethiopia trial. This analysis will generate economic evidence to inform the implementation of DATs in Ethiopia and globally. TRIAL REGISTRATION: Pan African Clinical Trial Registry (PACTR) PACTR202008776694999. Registered on 11 August 2020, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 .
背景:结核病仍然是资源有限环境中导致死亡的主要传染病。有效的治疗是结核病控制的基石,可以降低死亡率、复发率和传播率。通过医疗机构观察药物服用来支持治疗依从性可能会给提供者和患者带来高昂的成本。数字药物依从性技术(DATs)可能有助于监测治疗和差异化护理。ASCENT-埃塞俄比亚研究是一项三臂集群随机试验,评估了两种 DATs 和差异化护理,以支持埃塞俄比亚的结核病治疗依从性。这项研究是 ASCENT 联盟的一部分,该联盟在南非、菲律宾、乌克兰、坦桑尼亚和埃塞俄比亚评估 DATs。本研究的目的是确定在埃塞俄比亚实施 DATs 的成本、成本效益和公平影响。
方法和设计:共有 78 家卫生机构被随机分为两组(1:1:1),分别为干预组或标准护理组。每个卫生机构大约有 50 名参与者参加试验。被随机分配到干预组的参与者提供与 ASCENT 依从性平台相关联的 DAT,用于日常依从性监测,并对漏服药物的人进行差异化反应。标准护理设施的参与者接受常规护理。将为每个参与者测量治疗结果和资源利用情况。主要有效性结果是不良治疗结束结局(失访、死亡或治疗失败)或治疗结束后 6 个月内复发的综合指数。对于成本效益分析,将使用治疗结束结局来估计避免的残疾调整生命年(DALYs)。将从每个研究臂的 5 个卫生机构收集 50 名参与者的提供者和患者成本数据(n=150)。我们将使用贝叶斯层次模型进行社会成本效益分析,该模型考虑了成本和结果之间的个体相关性以及簇内相关性。将进行公平影响分析,以总结公平效率权衡。
讨论:试验招募正在进行中。本文遵循已发表的试验方案,并描述了 ASCENT-埃塞俄比亚试验的健康经济学工作包的方案和分析计划。该分析将生成经济证据,为在埃塞俄比亚和全球实施 DATs 提供信息。
试验注册:泛非临床试验注册处(PACTR)PACTR202008776694999。于 2020 年 8 月 11 日注册,https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241。
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