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: 10447735
• 负责人: MAUNANK SHAH
• 金额: $ 81.65万
• 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 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10447735
• 关键词: Address; Adherence; Adult; Affect; Baltimore; Behavior; COVID-19 impact; 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 Population; Length; Low Income Population; Maryland; Measurement; Medical; Modeling; Monitor; Mycobacterium tuberculosis; Not Hispanic or Latino; Nursing Assessment; Outcome Measure; Participant; Patients; Persons; 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(TB)是一种由结核分枝杆菌引起的高度传染性疾病，目前仍是主要的公共疾病。 美国的健康问题。识别和治疗潜伏性结核病患者是 在美国实现消除结核病的目标，但要实现这一目标还有许多挑战。在……里面 巴尔的摩，这项研究将在那里进行，超过三分之一的非美国出生的人有潜伏期 结核病，他们不成比例地受到增加进展为活动期风险的并存疾病的影响 结核病，如糖尿病和艾滋病毒。然而，社会经济因素，如贫困、获得护理、保健、 识字、语言或文化障碍是治疗的障碍。一例无症状患者的治疗 对于有许多其他相互竞争的需求的患者来说，潜伏性结核病等疾病很少是优先事项。的长度 治疗(几个月的标准“短程”疗法)也是有问题的，尤其是对病人来说。 经历住房或金融不稳定。因此，大多数感染潜伏性结核病的人并不 彻底治疗。我们建议评估支持智能手机的新颖且可扩展的干预措施，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 通过允许对遵从性进行实时监控并结合案例管理反馈来支持遵从性， 以患者的首选语言提供，并提供电子提醒。同样，行为经济学 (财政)奖励，即患者根据服用处方药获得奖励， 可以缓解与医疗保健和工资损失相关的经济压力，这是许多人共同关心的问题 潜伏性结核感染患者。患有潜伏性结核病(N=399)的成年人将被随机分配到普通护理对照组，或 VDOT或VDOT Plus奖励小组。常规护理控制参与者将接受潜伏期的标准护理 结核病。VDOT参与者将获得相同的常规服务，但将使用智能手机和商业 可用于接收电子提醒、提交视频观察以遵守文件的应用程序，以及 接收案例管理的实时反馈。VDOT PLUS奖励计划参与者将获得进一步的支持 通过根据VDOT服用处方药的或有经济奖励(每周最高35美元) 系统。将对所有人评估主要结果指标，即是否完成对潜伏性结核病的治疗。 学员通过MEMS CAPS(目标1)。我们还将确定成本、预算影响和 VDOT和VDOT加奖励干预措施的增量成本效益(目标2)。如果这次干预 在促进完成对潜伏结核病的治疗方面是有效的，并且在经济上是健全的，它可能被证明是一种 可推广和有效的干预措施，以促进#年高危人群完成潜伏结核病的治疗 巴尔的摩和世界各地的其他人口。