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