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

 在全国1000万至1500万潜伏性结核病感染（LTBI）的居民中，只有3%的人每年接受治疗，其中约一半人未能完成推荐的9个月治疗，使他们有患结核病的风险。鉴于自1993年以来，美国结核病控制措施每年都使结核病发病率持续下降，预防进展为活动性结核病的LTBI治疗对消除结核病至关重要。CDC最近批准了一种短期LTBI治疗方案，包括3个月每周一次的异烟肼[H]和利福喷丁[P]（3 HP），发现其与9个月每日自我给药的异烟肼（9 H-SAT）一样有效，可以大大提高治疗的开始和完成率。但是，3 HP必须通过直接观察治疗（DOT）进行给药，以确保所有剂量均按计划服用。由于DOT是劳动密集型的，依赖于交通，限于营业时间，对患者不方便，当患者旅行或居住远离卫生诊所时不切实际，因此结核病控制计划的采用受到限制。视频DOT（VDOT）是我们开发的移动健康应用程序，允许患者记录和发送他们服用药物的视频，由结核病护理提供者观看，以记录治疗依从性。一项由NIH资助的在接受TB疾病治疗的患者中进行的试点研究（R21-AI 088326; PI：Garfein）显示，与亲自DOT相比，依从性>94%，患者接受度高，成本显著降低。拟定的随机对照试验将测试使用VDOT监测接受3 HP的患者是否比使用基于诊所的现场DOT监测接受3 HP的患者实现更高的治疗完成率和更高的患者可接受性以及更低的成本。该研究将：比较VDOT与当面DOT患者之间的治疗完成率和依从率，并将确定与这些结局相关的患者因素（目标1）;测量VDOT与当面DOT监测患者之间的可接受性差异，并确定与接受性相关的因素（目标2）;以及测量VDOT与当面DOT用于3 HP的成本效益（目标3）。由医生开具3 HP处方的患者将被随机分配（n=155/组）接受VDOT或亲自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LTBI重新激活的最大风险。非常需要有效和负担得起的方法来监测对各种健康状况的治疗依从性，因为依从性差可能产生耐药病原体，并破坏对这些疾病的已证明有效的治疗。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。这项研究解决了迫切需要的成本效益的手段，打击收购，发展和结核病和耐药结核病的传播。

 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.