Mobile Phone-Based Video Directly Observed Therapy for Tuberculosis

描述(申请人提供)：据估计，世界人口的三分之一感染结核分枝杆菌，每年导致920万结核病病例和220万人死亡。如果不能很好地遵守持续6个月的治疗方案，疾病就会发展，患者仍然具有传染性，突变会使细菌对抗结核药物产生抗药性。依从性差对个人和社区的影响是如此之大，以至于世界各地的卫生机构建议，只要可行，就应该观察患者服用每一剂药物，称为直接观察疗法(DOT)。然而，DOT是资源密集型的，对患者有限制，对于居住在远离DOT提供者的患者来说是不可用的。这项研究的目的是开发和试点测试一种通过视频手机提供远程DOT的灵活且具有成本效益的方法，患者将使用这种方法来拍摄自己服用药物的视频，并将视频传输给DOT工作人员进行审查。视频手机DOT(VCP-DOT)的优势包括可以在任何时间从任何地点拍摄视频，并且DOT工作人员可以通过方便地查看视频来管理更大的案例负载。我们的长期目标是为发达国家和发展中国家的结核病控制项目提供改进的有效治疗结核病的方法。这项探索性/开发性R21研究的目的是：1)在患者和提供者中确定VCP-DOT交付的可修改障碍和促进者；2)确定VCP-DOT的可接受性和可行性，并估计与面对面DOT相比的治疗依从率；以及3)描述患者使用VCP-DOT的经历，以确定可能影响依从性和患者满意度的计划组件。我们假设VCP-DOT是患者可以接受的，并以比亲自DOT更低的成本实现了更好的治疗依从性。为了实现这些目标，我们将开展一系列焦点小组，以确定来自结核病保健提供者和患者的VCP-DOT的促进者和障碍。重点小组将首先在圣地亚哥确定主要主题，然后在提华纳确定文化和特定背景的差异。这些信息将被用来微调干预措施，然后在圣地亚哥的40名患者和蒂华纳的10名患者中进行试点测试，以评估其可行性、可接受性、成本和潜在疗效，并与现有的DOT计划进行比较。试点还可能揭示干预的技术优势和劣势。研究结果将被用来提出一项足够强大的随机对照试验，以测试VCP-DOT在国际环境中的疗效和成本效益。这项研究将在美国/墨西哥边境城市圣地亚哥和提华纳进行，因为这两个城市的高结核病发病率和邻近地区使我们能够在两个结核病控制系统截然不同的地区经济高效地开发和试点VCP-DOT。如果有效，VCP-DOT可以极大地减轻患者及其提供者的结核病治疗负担和成本，从而提高治疗依从性，并在全球范围内扩大治疗选择，包括那些生活在亲自DOT范围之外的患者。 与公共卫生相关：在结核病治疗持续时间从目前的6个多月大幅缩短之前，需要新的方法来以经济高效的方式确保高水平的治疗依从性，以治愈患者并避免产生抗结核病耐药性。这项探索性/发展性研究将评估使用摄像手机提供直接观察的结核病治疗。这项研究响应了美国联邦结核病工作组的建议，即“通过行为研究确定当前使用的治疗方案的替代方案和辅助方案，以提高(国内和国际)治疗的依从性”。

DESCRIPTION (provided by applicant): An estimated one-third of the world's population is infected with M. tuberculosis, resulting in 9.2 million cases of tuberculosis (TB) and 2.2 million deaths annually. Without good compliance with treatment regimens lasting =6 months, illness progresses, patients remain contagious, and mutations form rendering the bacteria resistant to anti-TB medications. So great are the individual and community level impacts of poor adherence that health agencies worldwide recommend that, whenever feasible, patients should be observed taking each dose of medication, referred to as directly observed therapy (DOT). However, DOT is resource intensive, restrictive to patients, and unavailable to patients who live far from DOT providers. The purpose of this study is to develop and pilot test a flexible and cost-effective method of providing remote DOT via video cellular phones, which patients will use to video themselves taking their medications and transfer the videos to DOT workers for review. Advantages of video cell phone DOT (VCP-DOT) include the fact that videos can be taken from any location at any time and DOT workers can manage larger case loads by reviewing videos at their convenience. Our long term goal is to provide TB control programs in developed and developing countries with improved methods of effectively treating TB. The aims of this Exploratory/Developmental R21 research study are to; 1) identify modifiable barriers and facilitators to VCP-DOT delivery among patients and providers; 2) determine the acceptability and feasibility of VCP-DOT and estimate treatment adherence rates compared to in-person DOT; and 3) characterize patient experiences with VCP-DOT to identify program components that could impact adherence and patient satisfaction. We hypothesize that VCP-DOT is acceptable to patients and achieves greater treatment adherence at a lower cost than in-person DOT. To address these aims we will conduct a series of focus groups to identify facilitators and barriers to VCP-DOT elicited from TB healthcare providers and patients. Focus groups will first be conducted in San Diego to identify major themes, and then in Tijuana to identify cultural and setting-specific differences. This information will be used to fine-tune the intervention before it is pilot tested among 40 patients in San Diego and 10 patients in Tijuana to assess its feasibility, acceptability, cost and potential efficacy compared to existing DOT programs. The pilot might also reveal technical strengths and weaknesses of the intervention. Findings will be used to propose a sufficiently powered randomized controlled trial to test the efficacy and cost-effectiveness of VCP-DOT in international settings. This study will take place in the US/Mexico border cities of San Diego and Tijuana, because their high TB incidence rates and close proximity allow us to cost-effectively develop and pilot test VCP-DOT in two areas with vastly different TB control systems. If effective, VCP-DOT could dramatically reduce the burden and cost of TB treatment to patients and their providers, thereby increasing treatment adherence and expanding treatment options globally including among patients who live beyond the reach of in-person DOT. PUBLIC HEALTH RELEVANCE: Until TB treatment duration is significantly reduced from the current 6-plus months, novel methods are needed to cost-effectively assure high levels of treatment adherence to cure the patient and avoid development of anti- TB drug resistance. This Exploratory/Developmental study will evaluate the use of video-camera cell phones to deliver directly observed TB therapy. This study is responsive to the U.S. Federal TB Task Force's recommendation for "identifying alternatives and adjuncts to currently used treatment protocols through behavioral research to improve adherence to therapy (domestic and international)".