Kilimanjaro Clinical Research Institute (KCRI), PO Box 2236, Moshi, Tanzania.
Department of International Health, RadboudUMC, Nijmegen, the Netherlands.
Trials. 2019 Jul 12;20(1):426. doi: 10.1186/s13063-019-3483-4.
Adherence to tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization has recommended the use of digital adherence monitoring technologies in its End TB Strategy. However, evidence on improving adherence is limited. EvriMED is a real-time medication-monitoring device which was found to be feasible and acceptable in a few studies in Asia. In Tanzania, however, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy, and cost effectiveness, which may have implications for treatment outcome. We propose a pragmatic cluster randomized trial to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania.
METHODS/DESIGN: We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented, or a control arm, where standard practice directly observed treatment will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the 'Stages of Change' model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action, and evaluation to change behavior for tailored feedback on adherence reports from the device.
If the intervention shows a significant effect on adherence and the devices are accepted, accurate, and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes.
Pan African Clinical Trials Registry, PACTR201811755733759 . Registered on 8 November 2018.
由于多种因素，结核病（TB）治疗的依从性具有挑战性。世界卫生组织（WHO）在其终止结核病策略中建议使用数字药物依从性监测技术。然而，改善依从性的证据有限。EvriMED 是一种实时药物监测设备，在亚洲的一些研究中被发现是可行且可接受的。然而，在坦桑尼亚，由于污名化、网络和电力接入、准确性和成本效益等问题，实施 EvriMED 可能面临挑战，这可能对治疗结果产生影响。我们提出了一项实用的群组随机试验，以研究 EvriMED 带有提醒提示和针对坦桑尼亚乞力马扎罗地区 TB 治疗依从性的个性化反馈对提高依从性的效果。
方法/设计：我们将根据医疗保健设施的级别在乞力马扎罗创建群组。群组将在干预组（实施 EvriMED）或对照组（采用标准直接观察治疗）中进行随机分组。干预组中的 TB 患者将从 EvriMED 药盒中服药，并获得个性化反馈。我们将使用“改变阶段”模型，该模型假设一个人必须经历前思考、思考、准备、行动和评估阶段，才能根据设备的依从性报告进行行为改变，以获得个性化反馈。
如果干预对依从性有显著影响，并且设备被接受、准确且可持续，那么该干预措施可以在国家结核病规划中扩大规模。
泛非临床试验注册中心，PACTR201811755733759。注册于 2018 年 11 月 8 日。
