Measuring Real-Time Influences of Mental and Tangible Resources on Men's TB Treatment Lapses and Adherence Behaviors

项目摘要 2018年，全球约有1000万人患上结核病，其中男性年龄≥15岁 占了50%以上的病例。南非国家结核病流行率研究报告称， 与妇女相比，结核病负担更高，病例发现率更低，报告差距更大。分析 南非的结核病护理级联显示，只有53%的结核病患者完成了治疗。最引人注目的是，结核病 在南非，男女预期寿命差异的很大一部分是由性别因素造成的。 南非要实现到2025年将结核病发病率减半的终结结核病战略目标，就必须 实施有效的干预措施，以支持参与和保持结核病护理，特别是在男性中。 这项研究将开发一种方法，通过以下方式实时收集影响结核病治疗的因素和资源： 将改良的生态瞬时评估（mEMA）与药物事件监测系统相结合 （MEMS）并评估其可行性。这项研究将围绕两个目标进行。 在目标1中，我们将集成EMA和MEMS，然后确定功能和可用性。这一目标将是 分两个阶段进行。在第一阶段，研究团队将整合Wisepill技术（MEMS） 与研究人员一起进行功能模拟。在第二阶段， mEMA-MEMS平台将有20名参与者，10名男性和10名女性。这一阶段将涉及一个 有声思维方法和使用mEMA-MEMS平台与研究移动的电话进行的30天测试。发现将 通知目标2的最终mEMA-MEMS平台。 在目标2中，我们将进行一项观察性队列研究，共有60名参与者（30名男性和30名女性）， 肺结核治疗。所有参与者将接受如何使用mEMA-MEMS平台的培训，并提供一份研究报告。 移动的电话。每28天，他们将返回临床研究中心，重新给Wisepill补充药物。期间 在本研究中，每名受试者将根据其给药行为接受随机和事件mEMA。参与者 将在入组时、继续治疗期间和继续治疗后阶段接受访谈，以评估 可行性、可接受性、意愿和安全性。我们还将收集初步数据 为了了解在结核病治疗过程中影响结核病治疗的社会心理和环境因素，结果将 用于通知后续研究设计。 这项研究的结果将为一项更大的R 01观察性研究提供信息，该研究将确定 在治疗过程中的特定时间需要，以支持依从性，并确定哪些资源 对所有人都具有普遍性，对男性具有独特性，因此可以制定和测试干预措施，以支持 他们的依从性和结核病治疗结果。

PROJECT ABSTRACT In 2018, approximately 10 million people developed TB disease globally, of which men aged ≥15 years accounted for over 50% of the cases. South African national TB prevalence studies have reported that men had a higher burden of TB, a lower case detection and larger reporting gaps compared to women. An analysis of South Africa's TB care cascade revealed that only 53% of TB patients completed treatment. Most strikingly, TB in South Africa is responsible for a large proportion of the difference in life expectancy between men and women. For South Africa to contribute to the End TB Strategy target of halving TB incidence by 2025, it is imperative to implement effective interventions to support engagement and retention in TB care, especially among men. This study will develop a method to gather factors and resources influencing TB treatment in real-time, by integrating modified ecological momentary assessments (mEMA) with medication event-monitoring system (MEMS) and assessing its feasibility. This study will be conducted over two aims. In Aim 1, we will integrate EMA and MEMS and then determine functionality and usability. This aim will be conducted over two phases. In Phase 1, the research study team will integrate the Wisepill technology (MEMS) with REDCap and conduct a functionality simulation with study staff. In Phase 2, a usability assessment of the mEMA-MEMS platform will be conducted with 20 participants, 10 men and 10 women. This phase will involve a think-aloud method and 30-day test using the mEMA-MEMS platform with a study mobile phone. Findings will inform the final mEMA-MEMS platform for Aim 2. In Aim 2, we will conduct an observational cohort study with 60 participants (30 men and 30 women) initiating TB treatment. All participants will be trained on how to use the mEMA-MEMS platform and provided a study mobile phone. Every 28 days, they will return to the clinic study site to refill their Wisepill with medication. During the study, each participant will receive random and event mEMAs based on their dosing behaviors. Participants will be interviewed at enrollment, during continuation and post-continuation stages of treatment, to assess feasibility, acceptability, willingness and safety using interviews and surveys. We will also collect preliminary data to understand psychosocial and contextual factors influential in TB treatment across the continuum, results will be used to inform subsequent study design. The results of this study will inform a larger R01 observational study that will determine what resources are needed at particular times during treatment to support adherence, and determine what resources are generalizable to all and distinctive for men such that an intervention may be developed and tested to support their adherence and TB treatment outcomes.