Video DOT and Economic Incentives to promote adherence to LTBI therapy

视频 DOT 和经济激励措施促进对 LTBI 治疗的依从性

• 批准号: 10274703
• 负责人: MAUNANK SHAH
• 金额: $ 81.17万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-08 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10274703
• 关键词: Address; Adherence; Adult; Affect; Baltimore; Behavior; COVID-19; Caring; Case Management; Cellular Phone; Cities; Clinic; Collaborations; Communities; Coupled; Data; Diabetes Mellitus; Diagnosis; Directly Observed Therapy; Disease; Dose; Drug Prescriptions; Effectiveness of Interventions; Feedback; Financial Hardship; Goals; HIV; Health; Health Services Accessibility; Health system; Homelessness; Housing; Immigrant; Incentives; Individual; Infection; Ingestion; Intervention; Language; Latin America; Latino; Length; Low Income Population; Maryland; Measurement; Medical; Modeling; Monitor; Mycobacterium tuberculosis; Not Hispanic or Latino; Nursing Assessment; Outcome Measure; Participant; Patients; Population; Poverty; Preventive therapy; Public Health; Quality-Adjusted Life Years; Randomized; Randomized Clinical Trials; Recommendation; Regimen; Reporting; Research; Rifamycins; Risk; Self Administration; Socioeconomic Factors; System; Testing; Time; Treatment Protocols; Tuberculosis; Uncertainty; United States; Wages; Work; arm; base; behavioral adherence; comorbidity; cost; cost effectiveness; cost estimate; economic behavior; economic evaluation; economic incentive; effective intervention; effectiveness evaluation; experience; financial incentive; health literacy; high risk; high risk population; improved; incremental cost-effectiveness; novel; prevent; primary outcome; programs; randomized trial; real time monitoring; scale up; sound; standard care; success; therapy design; transmission process; treatment as usual; trial comparing; tuberculosis treatment

Tuberculosis (TB), a highly contagious disease caused by Mycobacterium tuberculosis, remains a major public health concern in the United States. Identifying and treating individuals with latent TB is a key strategy to achieve the goal of TB elimination in the US but there are many challenges to achieving this goal. In Baltimore, where this research will be conducted, more than one-third of non-US-Born individuals have latent TB, and they are disproportionately affected by co-morbidities that increase the risk of progression to active TB, such as diabetes and HIV. However, socioeconomic factors such as poverty, access to care, health literacy, and language or cultural barriers present obstacles to treatment. Treatment for an asymptomatic condition, such as latent TB, is rarely a priority for patients with many other competing needs. The length of treatment (several months for standard “short-course” regimens) is also problematic, particularly for patients experiencing housing or financial instability. Therefore, the majority of individuals infected with latent TB do not complete treatment. We propose to evaluate novel and scalable smartphone enabled interventions to promote completion of treatment for latent TB. Video-directly observed therapy (vDOT) provides multi-faceted adherence support by allowing real-time monitoring of adherence coupled with case-management feedback, is available in patient's preferred languages, and delivers electronic reminders. Likewise, behavior economic (financial) incentives, in which patients receive incentives contingent on ingesting prescribed medications, could mitigate financial stress associated with medical care and lost wages, a common concern among many patients with latent TB infection. Adults with latent TB (N=399) will be randomized to a Usual Care Control, or vDOT, or a vDOT Plus Incentives group. Usual Care Control participants will receive standard care for latent TB. VDOT participants will receive the same Usual Care, but will use smartphones and a commercially available application to receive electronic reminders, submit video-observations to document adherence, and receive case-management real-time feedback. VDOT plus Incentives participants will receive further support through contingent financial incentives (up to $35 per week) for taking prescribed medications under the vDOT system. The primary outcome measure, completion of treatment for latent TB, will be assessed for all participants through MEMS caps (Aim 1). We will also determine the costs, budgetary impact, and incremental cost-effectiveness of the vDOT and vDOT plus incentives interventions (Aim 2). If this intervention is effective in promoting completion of treatment for latent TB and is economically sound, it could prove to be a scalable and effective intervention to promote completion of treatment for latent TB in high-risk populations in Baltimore and in other populations around the world.

结核病是由结核分枝杆菌引起的一种高度传染性疾病， 美国的健康问题。识别和治疗潜伏性结核病患者是一项关键战略， 在美国实现消灭结核病的目标，但实现这一目标面临许多挑战。在 这项研究将在巴尔的摩进行，超过三分之一的非美国出生的人有潜在的 结核病，他们不成比例地受到并发症的影响，这些并发症增加了进展为活动性结核病的风险。 结核病，如糖尿病和艾滋病毒。然而，社会经济因素，如贫困，获得保健，健康 识字、语言或文化障碍是治疗的障碍。治疗无症状 对于有许多其他竞争性需求的患者来说，潜伏性结核病等疾病很少是优先考虑的。的长度 治疗（标准的“短期”方案需要几个月）也是有问题的，特别是对患者而言 经历住房或金融不稳定。因此，大多数感染潜伏性结核病的个体不会 完整的治疗。我们建议评估新的和可扩展的智能手机支持的干预措施，以促进 完成潜伏性结核病的治疗。视频直接观察治疗（vDOT）提供多方面的 通过允许实时监控依从性以及病例管理反馈， 以患者首选语言提供，并提供电子提醒。同样，行为经济学 （经济）激励措施，其中患者获得的激励取决于所开的处方药， 可以减轻与医疗保健和工资损失相关的财务压力，这是许多人共同关注的问题 潜伏性结核病感染者。潜伏性TB成人患者（N=399）将被随机分配至住院护理对照组，或 vDOT或vDOT Plus激励组。患者护理对照组参与者将接受潜伏期的标准护理 TB. VDOT参与者将获得相同的医疗保健，但将使用智能手机和商业 可用的应用程序，以接收电子提醒，提交视频意见，以文件的遵守，和 接收案件管理实时反馈。VDOT+奖励参与者将获得进一步的支持 通过对根据vDOT服用处方药的应急经济激励（每周最高35美元） 系统将评估所有患者的主要结局指标，即潜伏性结核病治疗的完成情况 通过MEMS帽（目标1）的参与者。我们还将确定成本，预算影响， vDOT和vDOT+激励措施的增量成本效益（目标2）。如果这次干预 在促进完成潜伏性结核病治疗方面是有效的，而且在经济上是合理的，它可能被证明是一种 可扩展和有效的干预措施，以促进在高危人群中完成潜伏性结核病的治疗， 在巴尔的摩和世界其他地区的人群中。