Cell Phone Video Directly Observed Therapy to Monitor Short Course LTBI Treatment

手机视频直接观察治疗监测短期 LTBI 治疗

• 批准号: 8848622
• 负责人: Richard S Garfein
• 金额: $ 64.87万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-16 至 2020-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8848622
• 关键词: Address; Adherence; Adoption; Adverse effects; Businesses; Car Phone; Caring; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Cities; Clinic; Clinical Trials; Development; Directly Observed Therapy; Disease; Dose; Drug resistance; Drug resistance in tuberculosis; Eligibility Determination; Ensure; Freedom; Funding; Goals; HIV; HIV Infections; Health; Health Insurance Portability and Accountability Act; Health Personnel; Home environment; Hour; Human Resources; Immigrant; Incidence; Individual; Infection; Left; Life; Measures; Methods; Monitor; Mycobacterium tuberculosis; Outcome; Participant; Patient Monitoring; Patient Preferences; Patients; Persons; Pharmaceutical Preparations; Physicians; Pilot Projects; Prevention strategy; Provider; Public Health Practice; Randomized; Randomized Controlled Trials; Recovery; Refugees; Regimen; Relative (related person); Reporting; Research; Resources; Risk; Schedule; Self-Administered; Shelter facility; System; Testing; Text; Time; Transportation; Travel; Treatment Protocols; Tuberculosis; United States National Institutes of Health; Video Recording; arm; base; cloud based; combat; compliance behavior; cost; cost effective; cost effectiveness; disorder prevention; effective therapy; hamstring; high risk; improved; isoniazid; mHealth; meetings; mortality; novel; pathogen; prevent; programs; prototype; public health relevance; rifapentine; scale up; transmission process; treatment adherence; tuberculosis drugs; uptake; web site

 DESCRIPTION (provided by applicant): Only 3% of the nation's 10-15 million residents with latent tuberculosis infection (LTBI) are treated annually, of which approximately half fail to complete the recommended 9-month treatment leaving them at risk for developing tuberculosis (TB) disease. Given that U.S. TB control measures have produced consistent declines in TB disease incidence every year since 1993, LTBI treatment to prevent progression to active TB is vital for TB elimination. The CDC's recent approval of a short-course LTBI treatment regimen consisting of 3 months of weekly isoniazid [H] and rifapentine [P] (3HP)found to be as effective as 9 months of daily self-administered isoniazid (9H-SAT)could profoundly increase treatment initiation and completion rates. However, 3HP must be delivered via directly observed therapy (DOT) to ensure all doses are taken as scheduled. Since DOT is labor intensive, transportation dependent, limited to business hours, inconvenient for patients, and impractical when patients travel or live far from health clinics, adoption by TB control programs is limited. Video DOT (VDOT) is a mHealth application that we developed to allow patients to record and send videos of them ingesting medications, which are watched by TB care providers to document treatment adherence. An NIH- funded pilot study (R21-AI088326; PI: Garfein) among patients treated for TB disease showed >94% adherence with high patient acceptance and significantly reduced costs compared to in-person DOT. The proposed randomized controlled trial will test whether monitoring patients receiving 3HP with VDOT achieves higher treatment completion rates with greater patient acceptability at lower cost than 3HP with clinic-based in-person DOT. The study will: compare treatment completion and adherence rates between patients on VDOT versus in-person DOT and will identify patient factors associated with these outcomes (Aim 1); measure differences in patient acceptability between those monitored with VDOT versus in-person DOT and identify factors associated with acceptance (Aim 2); and, measure cost-effectiveness of VDOT versus in-person DOT for 3HP (Aim 3). Willing patients prescribed 3HP by their physicians, will be randomly assigned (n=155/arm) to be monitored by VDOT or in-person DOT. Participants will mainly include TB contacts, newly arrived refugees and immigrants, and persons with untreated HIV infection because they are at greatest risk for reactivation of LTBI. Effective and affordable methods to monitor treatment adherence for myriad health conditions are greatly needed given that poor adherence can produce drug-resistant pathogens and undermine proven effective treatments for these diseases. Study results will have immediate and direct impacts on public health practice for TB elimination, and provide evidence to support using VDOT to monitor adherence for other health conditions and clinical trials research. This study addresses the urgent need for cost-effective means of combatting the acquisition, development and transmission of TB and drug resistant TB.

 描述（由申请人提供）：全国 10-1500 万潜伏性结核感染 (LTBI) 居民中，只有 3% 每年接受治疗，其中约一半人未能完成建议的 9 个月治疗，使他们面临患结核病 (TB) 疾病的风险。鉴于自 1993 年以来美国结核病控制措施使结核病发病率逐年下降，因此采用 LTBI 治疗预防进展为活动性结核病对于消除结核病至关重要。 CDC 最近批准了由 3 个月每周一次异烟肼 [H] 和利福喷丁 [P] (3HP) 组成的短程 LTBI 治疗方案，该方案与 9 个月每天自行给药异烟肼 (9H-SAT) 一样有效，可以极大地提高治疗开始率和完成率。然而，3HP 必须通过直接观察治疗 (DOT) 进行，以确保所有剂量均按计划服用。由于 DOT 是劳动密集型、依赖交通、受营业时间限制、对患者不方便，并且当患者出行或居住地远离医疗诊所时不切实际，因此结核病控制项目的采用受到限制。视频 DOT (VDOT) 是我们开发的一款移动医疗应用程序，允许患者记录和发送他们服用药物的视频，结核病护理人员可以观看这些视频，以记录治疗依从性。一项由 NIH 资助的针对结核病治疗患者的试点研究（R21-AI088326；PI：Garfein）显示，与面对面 DOT 相比，患者的依从性高达 94% 以上，且患者接受度高，且成本显着降低。拟议的随机对照试验将测试通过 VDOT 监测接受 3HP 的患者是否能够以比基于诊所的现场 DOT 的 3HP 更低的成本实现更高的治疗完成率和更高的患者可接受性。该研究将： 比较 VDOT 与面对面 DOT 患者之间的治疗完成率和依从率，并确定与这些结果相关的患者因素（目标 1）；衡量通过 VDOT 监测的患者与现场 DOT 监测的患者可接受性之间的差异，并确定与接受度相关的因素（目标 2）；衡量 3HP 的 VDOT 与面对面 DOT 的成本效益（目标 3）。愿意由医生开出 3HP 处方的患者将被随机分配（n=155/组）接受 VDOT 或现场 DOT 监测。参与者主要包括结​​核病接触者、新抵达的难民和移民以及未经治疗的艾滋病毒感染者，因为他们是潜伏性结核病重新激活的风险最大的人。鉴于依从性差会产生耐药病原体并破坏对这些疾病的有效治疗，因此非常需要有效且负担得起的方法来监测各种健康状况的治疗依从性。研究结果将对消除结核病的公共卫生实践产生直接影响，并提供证据支持使用 VDOT 监测其他健康状况和临床试验研究的依从性。这项研究解决了对抗击结核病和耐药结核病的获得、发展和传播的具有成本效益的手段的迫切需求。