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

 描述(申请人提供)：在全国1,000-1,500万潜在结核病感染(LTBI)患者中，每年只有3%的人接受治疗，其中约一半人未能完成推荐的9个月治疗，从而面临发展为结核病(TB)的风险。鉴于自1993年以来，美国的结核病控制措施每年都导致结核病发病率持续下降，LTBI治疗以防止进展为活动性结核病对消除结核病至关重要。疾控中心最近批准了一种短程LTBI治疗方案，包括每周3个月的异烟肼[H]和利福喷丁[P](3HP)，其疗效相当于每天9个月的自我给药异烟肼(9H-SAT)，这可能会大大提高治疗的起始率和完成率。然而，3HP必须通过直接观察疗法(DOT)提供，以确保所有剂量都按计划服用。由于DOT是劳动密集型的，依赖于交通，仅限于营业时间，对患者不方便，当患者旅行或居住在远离健康诊所的地方时，DOT是不切实际的，因此结核病控制计划的采用是有限的。Video DOT(VDOT)是我们开发的一款mHealth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。一项由美国国立卫生研究院资助的试验性研究(R21-AI088326；PI：Garfein)在治疗结核病的患者中显示，与面对面DOT相比，&gt；94%的患者依从性高，患者接受度高，成本显著降低。拟议的随机对照试验将测试监测接受VDOT的3HP治疗的患者是否比接受以临床为基础的面对面DOT的3HP治疗的患者获得更高的治疗完成率和更大的患者接受度，同时成本更低。这项研究将：比较接受VDOT和面对面DOT的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)；衡量接受VDOT和面对面DOT监测的患者之间的患者接受度差异，并确定与接受相关的因素(目标2)；以及衡量VDOT和面对面DOT治疗3HP的成本效益(目标3)。由医生开出3HP处方的自愿患者将被随机分配(n=155/臂)接受VDOT或面对面DOT的监测。参与者将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，因为他们重新激活长期结核病的风险最大。鉴于依从性差可能产生抗药性病原体并破坏对这些疾病的有效治疗，迫切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。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，并为使用VDOT监测其他健康状况和临床试验研究的依从性提供证据。这项研究解决了迫切需要有成本效益的手段来抗击结核病和耐药结核病的获取、发展和传播。

 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.