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（由适用提供）：每年接受潜在结核病感染（LTBI）的100-1.5万居民中，只有3％接受治疗，其中大约一半未能完成建议的9个月治疗，使他们患有结核病（TB）疾病的风险。鉴于自1993年以来，美国结核病控制措施在每年的结核病疾病事件中都导致了一致的下降，因此，LTBI治疗以防止进展为主动结核病，这对于消除结核病至关重要。疾病预防控制中心（CDC）最近批准了一项短期LTBI治疗方案，该治疗方案由每周3个月的Isoniazid [H]和Rifapentine [P]（3HP）组成，发现与9个月的每日自我管理的Isoniazid（9H-SAT）一样有效，可以使治疗率和完成率深刻提高治疗率。但是，必须通过直接观察的治疗（DOT）进行3HP，以确保按计划服用所有剂量。由于DOT是劳动力密集的，依赖运输，仅限于营业时间，患者不便，并且在患者旅行或远离卫生诊所的情况下不切实际，因此结核病控制计划的采用是有限的。视频点（VDOT）是我们开发的MHealth应用程序，旨在允许患者录制和发送摄入药物的视频，TB护理提供者观看这些药物以记录治疗治疗依从性。与亲身点相比，一项由NIH资助的试点研究（R21-AI088326; PI：GARFEIN）在接受结核病疾病的患者中> 94％依从性> 94％，并且与亲人点相比，患者接受率高，成本大大降低。拟议的随机对照试验将测试监测接受3HP的患者是否达到更高的治疗完成率，患者的可接受性更高，其成本比3HP更低，而基于诊所的亲自点。该研究将：比较患者在VDOT与面对面点之间的治疗完成和依从率，并将确定与这些结果相关的患者因素（AIM 1）；测量通过VDOT与面对面点监测的患者可接受性的差异，并确定与接受有关的因素（AIM 2）；并且，测量3HP的VDOT与面对面点的成本效益（AIM 3）。愿意由医生开出3HP的患者将被随机分配（n = 155/ARM），以通过VDOT或面对面的DOT监测。参与者将主要包括结​​核病接触，新来的难民和移民以及未经治疗的艾滋病毒感染的人，因为他们有LTBI重新激活的极大风险。需要有效且负担得起的方法来监测对众多健康状况的治疗依从性，因此较差的依从性可以产生耐药的病原体并破坏被证明有效的病原体。这些疾病的治疗方法。研究结果将对消除结核病的公共卫生实践产生直接和直接的影响，并提供证据，以支持使用VDOT监测其他健康状况和临床试验研究的依从性。这项研究涉及对抗击结核病和耐药结核病的获取，开发和传播的迫切需求。