TB-TST (TB treatment support tools): Refinement and evaluation of an interactive mobile app and direct adherence monitoring on TB treatment outcomes

项目摘要 本研究的总体目标是完善结核病（TB）治疗支持工具（TB-TST）干预，该工具将使用 以用户为中心的设计原则和纸基药物代谢物尿液测试条修改为家庭使用，以改善治疗结果， 结核病患者，并通过随机对照试验评估其影响。结核病是一个紧迫的全球健康威胁，尽管它是世界上最致命的传染病， 在很大程度上可以治愈。对结核病治疗方案的药物依从性差，沿着在监测患者和使他们返回治疗方面的挑战， 是导致不良结局和耐药性发展的重要因素。结核病患者在获得良好治疗方面面临多重障碍 治疗依从性，如药物副作用，耻辱和缺乏有关疾病及其治疗的教育。随着进步，以及 随着移动的技术平台的扩散，人们对可能使用移动的健康干预措施来解决 这些挑战。在正在调查的结核病依从性监测mHealth方法中，药物代谢物检测已被确定为 与其他移动的解决方案（如视频）相比，这是最有前途、最符合道德规范、最准确、最不具侵入性和污名化的策略 观察，“智能”药瓶，可摄入的传感器），但其潜力仍然在很大程度上未被探索。此外，移动的应用程序（app） 可以提供个性化的治疗监督，增加患者的自我管理，并通过提供 更先进的功能，用于患者支持和监测。然而，现有的结核病相关应用程序并没有将患者作为最终目标， 用户也没有得到充分的评价。该建议建立在初步工作的基础上，以1）联合收割机从患者和专家的输入迭代地 设计治疗支持应用程序的内容、特性、功能和界面，以及2）优化用于测试 尿液中是否存在异烟肼药物代谢物，以直接监测治疗依从性。TB-TST应用程序的现有版本具有 它提供有关结核病及其治疗的教育，与护理协调员进行沟通，跟踪治疗依从性（通过 自我报告和直接代谢物测试条图像），自我报告治疗副作用，并保留患者的“日记”记录。的结果 这个版本的试点测试将是这项拟议研究的起点。目的是：1）在试点研究的基础上完善TB-TST干预措施 研究结果并应用以用户为中心的设计原则; 2）评价TB-TST对治疗结果（成功，默认）的影响， 3）评估患者和提供者对实施TB-TST的促进者和障碍的看法，并总结经验教训 与利益相关者和政策制定者一起学习。主要结局是治疗成功。次要结局将包括：治疗默认 率、自我报告的依从性、技术使用和可用性。研究结果不仅对结核病的依从性， 这将有助于我们更广泛地了解如何支持面临挑战性治疗方案的患者。

PROJECT SUMMARY The overall goal of this study is to refine the tuberculosis (TB) treatment support tools (TB-TST) intervention, which links an app developed using user-centered design principles and a paper-based drug metabolite urine test strip modified for home use, to improve treatment outcomes for patients with TB, and evaluate its impact by a RCT. TB is an urgent global health threat and the world's deadliest infectious disease despite it being largely curable. Poor medication adherence to TB regimens, along with challenges in monitoring patients and returning them to treatment, are important contributing factors to poor outcomes and the development of drug resistance. Individuals with TB face multiple barriers to good treatment adherence such as medication side effects, stigma, and lack of education about the disease and its treatment. With advances in, and proliferation of, mobile technology platforms, there is substantial interest in the possible use of mobile health (mHealth) interventions to address these challenges. Of the mHealth approaches under investigation for TB adherence monitoring, drug metabolite testing has been identified as the most promising, ethical, and accurate, and the least intrusive and stigmatizing strategy compared to other mobile solutions (eg, video observation, “smart” medication bottles, ingestible sensor), yet its potential remains largely unexplored. Additionally, mobile applications (apps) may provide personalized treatment supervision, increase patients' self-management and improve patient-provider communication by offering more advanced functionalities for patient support and monitoring. However, available TB-related apps have not focused on patients as the end- users nor have they been fully evaluated. This proposal builds on preliminary work to 1) combine input from patients and experts to iteratively design the content, features, functionalities, and interface of the treatment support app and 2) optimize a paper-based test strip for testing the presence of isoniazid drug metabolites in urine to directly monitor adherence to treatment. The existing version of the TB-TST app has the following functionalities: it offers education on TB and its treatment, communication with a care-coordinator, tracks treatment adherence (both by self-reporting and direct metabolite test strip images), self-reports treatment side-effects, and retains patient's “diary” notes. The results from the pilot test of this version will be the starting point for this proposed study. Aims are to: 1) Refine the TB-TST intervention based on pilot study findings and apply principles of user-centered design; 2) Evaluate the impact of the TB-TST on treatment outcomes (success, default) compared to usual care; 3) Assess patient and provider perceptions of the facilitators and barriers to implementation of the TB-TST and synthesize lessons learned with stakeholders and policy makers. The primary outcome will be treatment success. Secondary outcomes will include: treatment default rates, self-reported adherence, technology use and usability. Findings have broader implications not only for TB adherence but disease management more generally and will improve our understanding of how to support patients facing challenging treatment regimens.