Mobile Phone-Based Video Directly Observed Therapy for Tuberculosis

描述（由申请人提供）：据估计，世界上三分之一的人口感染了结核分枝杆菌，每年导致920万例结核病病例和220万人死亡。如果没有持续6个月的良好治疗方案依从性，疾病就会进展，患者仍具有传染性，并且会产生突变，使细菌对抗结核药物产生耐药性。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，应观察患者服用每一剂药物，即直接观察治疗（DOT）。然而，DOT是资源密集型的，对患者有限制，并且不适合远离DOT提供者的患者。本研究的目的是开发和试点一种灵活和经济的方法，通过视频手机提供远程DOT，患者将使用视频自己服用药物，并将视频传送给DOT工作人员进行审查。视频手机DOT （VCP-DOT）的优点包括视频可以在任何时间从任何地点拍摄，DOT工作人员可以通过在方便的时候查看视频来管理更大的案件负载。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规划提供有效治疗结核病的改进方法。这项探索性/发展性R21研究的目的是：1)确定在患者和提供者之间提供VCP-DOT的可修改障碍和促进因素；2)确定VCP-DOT的可接受性和可行性，并评估与面对面DOT相比的治疗依从率；3)用VCP-DOT描述患者体验，以确定可能影响依从性和患者满意度的项目组成部分。我们假设VCP-DOT对患者来说是可接受的，并且比面对面DOT的成本更低，治疗依从性更好。为了实现这些目标，我们将开展一系列焦点小组，以确定从结核病医疗保健提供者和患者中引出的VCP-DOT的促进因素和障碍。焦点小组将首先在圣地亚哥进行，以确定主要主题，然后在蒂华纳进行，以确定文化和特定背景的差异。在对圣地亚哥的40名患者和蒂华纳的10名患者进行试点测试之前，这些信息将用于对干预措施进行微调，以评估其可行性、可接受性、成本和与现有DOT计划相比的潜在功效。试点还可能揭示干预措施的技术优势和弱点。研究结果将用于提出一项足够有力的随机对照试验，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蒂华纳进行，因为这两个城市的结核病发病率高，距离近，使我们能够经济有效地在结核病控制系统截然不同的两个地区开发和试点VCP-DOT。如果有效，VCP-DOT可大大减轻结核病患者及其提供者的结核病治疗负担和费用，从而提高治疗依从性，并在全球范围内扩大治疗选择，包括无法亲自接受DOT治疗的患者。

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)".