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

基本信息

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
项目类别：
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

项目摘要

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，仍然是主要的公共卫生疾病在美国，识别和治疗潜伏性结核病患者是一项关键策略。在美国实现消除结核病的目标，但实现这一目标面临许多挑战。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，并且他们不成比例地受到合并症的影响，这些合并症增加了进展为活动性结核病的风险结核病，例如糖尿病和艾滋病毒，但是，社会因素例如贫困、获得护理的机会、健康状况。识字、语言或文化障碍给无症状患者的治疗带来障碍。对于有许多其他竞争需求的患者来说，诸如潜伏性结核病之类的疾病很少是优先事项。治疗（标准“短期”治疗方案需要几个月）也存在问题，特别是对于患者因此，大多数感染潜伏性结核病的人不会出现住房或经济不稳定的情况。我们建议评估新颖且可扩展的智能手机干预措施，以促进治疗。完成潜伏性结核病的治疗可提供多方面的视频直接观察治疗 (vDOT)。通过允许实时监控依从性以及案例管理反馈来提供依从性支持以患者喜欢的语言提供，并提供电子提醒，同样，行为经济。（经济）激励，患者根据服用处方药物获得激励，可以减轻与医疗保健和工资损失相关的财务压力，这是许多人共同关心的问题潜伏性结核感染的成人 (N=399) 将被随机分配至常规护理对照组，或 vDOT 或 vDOT Plus 激励小组的参与者将接受针对潜伏者的标准护理。 TB.VDOT 参与者将获得相同的常规护理，但将使用智能手机和商业设备可用的应用程序接收电子提醒，提交视频观察以记录遵守情况，以及接收案例管理实时反馈以及激励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）系统将评估所有患者的主要结局指标，即潜伏性结核病的治疗完成情况。我们还将确定成本、预算影响和 vDOT 和 vDOT 加激励干预措施的增量成本效益（目标 2）。能有效促进潜伏性结核病的治疗完成，并且经济上合理，它可能被证明是一种可扩展且有效的干预措施，以促进高危人群完成潜伏性结核病的治疗巴尔的摩和世界各地的其他人群。