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

测量精神和有形资源对男性结核病治疗失误和依从行为的实时影响

• 批准号: 10461850
• 负责人: Joseph Daniels
• 金额: $ 13.73万
• 依托单位: DESMOND TUTU HIV FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-05 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10461850
• 关键词: Accounting; Address; Adherence; Behavior; Buffaloes; Car Phone; Caring; Cessation of life; Child; Cities; Clinic; Clinical Treatment; Clinical Trials; Cohort Studies; Data; Data Collection; Detection; Diagnosis; Disease; Dose; Ecological momentary assessment; Education; Effectiveness; Effectiveness of Interventions; Enrollment; Ensure; Event; Exhibits; Future; Gender; Grant; HIV; Health behavior; Incentives; Incidence; Individual; Influentials; Intervention; Interview; Laboratories; Life Expectancy; Maps; Measures; Meta-Analysis; Methods; Modeling; Monitor; Observational Study; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Phase; Population; Prevalence; Prevalence Study; Provider; Province; Psyche structure; Psychosocial Factor; Reporting; Research; Research Design; Research Methodology; Resources; Safety; Secure; Sex Differences; Signal Transduction; Site; Social Behavior; South Africa; South African; Surveys; Symptoms; System; Technology; Testing; Time; Time Factors; Tracer; Training; Treatment outcome; United States National Institutes of Health; Woman; Work; aged; base; behavioral adherence; clinical care; clinically relevant; contextual factors; data exchange; effective intervention; effectiveness measure; improved; innovation; insight; mHealth; male health; medication compliance; men; primary outcome; programs; psychologic; research study; satisfaction; secondary outcome; sex; simulation; therapy development; treatment adherence; tuberculosis treatment; usability; willingness

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.

项目摘要 2018年，全球约有1000万人罹患结核病，其中男性年龄≥15岁 南非国家结核病患病率研究报告称，男性结核病病例占 50% 以上。 与女性相比，结核病负担更高，病例发现率更低，报告差距更大。 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，男性和女性预期寿命的差异在很大程度上是由性别差异造成的。 南非若要为到 2025 年将结核病发病率减半这一终止结核病战略目标做出贡献，就必须 实施有效的干预措施，支持结核病护理的参与和保留，尤其是男性。 本研究将开发一种实时收集影响结核病治疗的因素和资源的方法，方法是： 改良的生态瞬时评估（mEMA）与药物事件监测系统的整合 （MEMS）并评估其可行性这项研究将针对两个目标进行。 在目标 1 中，我们将集成 EMA 和 MEMS，然后确定功能和可用性。 分两个阶段进行，在第一阶段，研究团队将整合 Wisepill 技术 (MEMS)。 与 REDCap 并与研究人员进行功能模拟 在第二阶段，进行可用性评估。 mEMA-MEMS 平台将由 20 名参与者（10 名男性和 10 名女性）进行。 使用 mEMA-MEMS 平台和研究手机进行有声思考法和 30 天测试。 告知目标 2 的最终 mEMA-MEMS 平台。 在目标 2 中，我们将开展一项观察性队列研究，有 60 名参与者（30 名男性和 30 名女性）发起 所有参与者都将接受有关如何使用 mEMA-MEMS 平台的培训并提供一项研究。 每 28 天，他们将返回诊所研究地点，为他们的 Wisepill 补充药物。 在该研究中，每个参与者将根据他们的给药行为收到随机和事件 mEMA。 将在入组时、继续治疗期间和继续治疗后阶段接受采访，以评估 我们还将通过访谈和调查来收集初步数据。 为了了解整个过程中对结核病治疗有影响的社会心理和背景因素，结果将 用于指导后续的研究设计。 这项研究的结果将为更大规模的 R01 观察性研究提供信息，该研究将确定哪些资源 在治疗期间的特定时间需要支持依从性，并确定需要哪些资源 可以推广到所有人，但对男性来说是独特的，因此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。