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1,000万人患上结核病，其中男性年龄为15岁(≥ 占案件总数的50%以上。南非国家结核病流行研究报告称，男性患有 与妇女相比，结核病负担更重，病例发现率更低，报告差距更大。一种分析 南非的结核病护理瀑布显示，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，男性和女性之间的预期寿命差异有很大一部分是由男性和女性造成的。 南非要为到2025年将结核病发病率减半的结束结核病战略目标做出贡献，就必须 实施有效的干预措施，支持参与和保留结核病护理，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 改良生态瞬时评估(MEMA)与用药事件监测系统的集成 (MEMS)并评估其可行性。这项研究将在两个目标上进行。 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，研究研究团队将整合Wisepill技术(MEMS) 并与研究人员一起进行功能模拟。在阶段2中，对 MEMA-MEMS平台将由20名参与者进行，其中男性10名，女性10名。这一阶段将涉及 使用MEMA-MEMS平台和一部学习手机进行30天的有声思考测试。调查结果将 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，60名参与者(30名男性和30名女性)开始 结核病治疗。所有参与者将接受如何使用MEMA-MEMS平台的培训，并提供了一项研究 手机。每隔28天，他们会回到临床研究现场，给他们的Wisepill补充药物。在.期间 在这项研究中，每个参与者都将根据他们的服药行为收到随机和事件mEMA。参与者 将在登记时、继续治疗期间和继续治疗后阶段进行面谈，以评估 可行性、可接受性、意愿和安全性采用访谈和调查。我们还将收集初步数据 为了了解心理社会和背景因素在整个过程中对结核病治疗的影响，结果将 用于为后续研究设计提供信息。 这项研究的结果将为一项更大的R01观察性研究提供信息，该研究将确定哪些资源是 在治疗期间的特定时间需要，以支持依从性，并确定哪些资源 对所有人都是通用的，对男性是独特的，这样就可以开发和测试干预措施来支持 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.