Tadesse Amare W, Mohammed Zemedu, Foster Nicola, Quaife Matthew, McQuaid Christopher Finn, Levy Jens, van Kalmthout Kristian, van Rest Job, Jerene Degu, Abdurhman Tofik, Yazew Hiwot, Umeta Demekech G, Assefa Demelash, Weldemichael Gedion T, Bedru Ahmed, Letta Taye, Fielding Katherine L
TB Centre, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.
KNCV Tuberculosis Foundation, Addis Ababa, Ethiopia.
BMC Infect Dis. 2021 Nov 10;21(1):1149. doi: 10.1186/s12879-021-06833-x.
Digital adherence technologies (DATs) are recommended to support patient-centred, differentiated care to improve tuberculosis (TB) treatment outcomes, but evidence that such technologies improve adherence is limited. We aim to implement and evaluate the effectiveness of smart pillboxes and medication labels linked to an adherence data platform, to create a differentiated care response to patient adherence and improve TB care among adult pulmonary TB participants. Our study is part of the Adherence Support Coalition to End TB (ASCENT) project in Ethiopia.
METHODS/DESIGN: We will conduct a pragmatic three-arm cluster-randomised trial with 78 health facilities in two regions in Ethiopia. Facilities are randomised (1:1:1) to either of the two intervention arms or standard of care. Adults aged ≥ 18 years with drug-sensitive (DS) pulmonary TB are enrolled over 12 months and followed-up for 12 months after treatment initiation. Participants in facilities randomised to either of the two intervention arms are offered a DAT linked to the web-based ASCENT adherence platform for daily adherence monitoring and differentiated response to patient adherence for those who have missed doses. Participants at standard of care facilities receive routine care. For those that had bacteriologically confirmed TB at treatment initiation and can produce sputum without induction, sputum culture will be performed approximately 6 months after the end of treatment to measure disease recurrence. The primary endpoint is a composite unfavourable outcome measured over 12 months from TB treatment initiation defined as either poor end of treatment outcome (lost to follow-up, death, or treatment failure) or treatment recurrence measured 6 months after the scheduled end of treatment. This study will also evaluate the effectiveness, feasibility, and cost-effectiveness of DAT systems for DS-TB patients.
This trial will evaluate the impact and contextual factors of medication label and smart pillbox with a differentiated response to patient care, among adult pulmonary DS-TB participants in Ethiopia. If successful, this evaluation will generate valuable evidence via a shared evaluation framework for optimal use and scale-up.
Pan African Clinical Trials Registry PACTR202008776694999, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 , registered on August 11, 2020.
数字依从性技术（DATs）被推荐用于支持以患者为中心的差异化护理，以改善结核病（TB）治疗效果，但此类技术能提高依从性的证据有限。我们旨在实施并评估与依从性数据平台相连的智能药盒和药物标签的有效性，针对患者的依从性制定差异化护理应对措施，并改善成年肺结核参与者的结核病护理。我们的研究是埃塞俄比亚终止结核病依从性支持联盟（ASCENT）项目的一部分。
方法/设计：我们将在埃塞俄比亚两个地区的78个卫生机构开展一项实用的三臂整群随机试验。机构被随机（1:1:1）分配至两个干预组或标准护理组之一。年龄≥18岁的药物敏感型（DS）肺结核成年患者在12个月内入组，并在开始治疗后随访12个月。随机分配至两个干预组之一的机构中的参与者会获得一个与基于网络的ASCENT依从性平台相连的DAT，用于日常依从性监测，并对漏服药物的患者的依从性做出差异化应对。接受标准护理的机构中的参与者接受常规护理。对于那些在开始治疗时痰菌学确诊为结核病且无需诱导就能咳出痰液的患者，将在治疗结束后约6个月进行痰培养，以测量疾病复发情况。主要终点是从结核病治疗开始起12个月内测量的综合不良结局，定义为治疗结局不佳（失访、死亡或治疗失败）或在预定治疗结束后6个月测量的治疗复发。本研究还将评估DAT系统对DS-TB患者的有效性、可行性和成本效益。
本试验将评估药物标签和智能药盒在埃塞俄比亚成年DS-TB肺结核参与者中对患者护理做出差异化应对的影响及相关背景因素。如果成功，该评估将通过一个共享评估框架为最佳使用和扩大规模提供有价值的证据。
泛非临床试验注册中心PACTR202008776694999，https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 ，于2020年8月11日注册。
