Tel-Me-Box: Validating and testing a novel, low-cost, real-time monitoring device with hair level analysis among adherence-challenged patients

Tel-Me-Box：验证和测试一种新型、低成本、实时监测设备，可在依从性有问题的患者中进行头发水平分析

• 批准号: 9039510
• 负责人: Maria L. Ekstrand
• 金额: $ 64.6万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-23 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9039510
• 关键词: Adherence; Adopted; Anti-Retroviral Agents; Back; Behavioral; Biological; Biological Assay; Biological Markers; Biological Monitoring; Boxing; Charge; Chronic Disease; Clinic; Computer software; Data; Devices; Disclosure; Drug resistance; Electronics; Engineering; Enrollment; Ensure; Feedback; Future; Gold; HIV; HIV therapy; Hair; India; Individual; Ingestion; Institutes; Interdisciplinary Study; Laboratories; Lead; Life; Light; Measurement; Measures; Medical; Methods; Modeling; Modification; Monitor; Nature; Outcome; Participant; Patient Self-Report; Patients; Pattern; Pharmaceutical Preparations; Pilot Projects; Plasma; Prevention; Privacy; Procedures; Provider; Randomized Clinical Trials; Recording of previous events; Reporting; Research; Research Institute; Resources; Risk; Sampling; Science; Scientist; Signal Transduction; System; Technology; Testing; Time; Training; Treatment outcome; Viral Load result; Wireless Technology; arm; base; cohort; cost; design; expectation; improved; innovation; liquid chromatography mass spectrometry; monitoring device; novel; pill; programs; prototype; public health relevance; quality assurance; response; social stigma; therapy adherence; tool; vibration

 DESCRIPTION (provided by applicant): Novel, validated methods to monitor adherence to HIV treatment in real time are urgently needed given the well-known limitations of self-reported adherence, pill counts, and medication electronic monitoring system (MEMS) caps. In order to be scalable and sustainable in both resource-rich and resource limited settings, such devices need to be low-cost and designed in a way that does not increase the risk of accidental HIV disclosure and subsequent stigma. Devices which both monitor adherence in real time and provide tailored reminders to patients for medication-taking have the potential to greatly improve adherence to HIV treatment as well as to treatment for other chronic diseases. Our Indo-US collaborative team has been conducting research on HIV stigma, ARV adherence patterns and barriers, treatment outcome, and drug resistance for over a decade. We have also pioneered the use of ARV concentrations in small hair samples to measure long-term ARV adherence in resource-rich and limited settings (RLS). In response to the need for novel adherence meaures, our team has recently developed Tel-Me-Box, a small, low-cost adherence device that monitors adherence in real time, by transmitting a wireless signal to a server when opened. We now propose to add hardware that will enable the server software to wirelessly program the device to activate tailored medication-taking reminders (via a beep, vibration, or LED light) after a period of inactivity. The device fits in a pocket, can hold 1-2 weeks' worth of medications, has a long battery life, simple charging capability, and has been found acceptable to Indian patients with adherence challenges in pilot studies. Since HIV stigma serves as a profound barrier to ARV adherence in many settings, including India, the small, inconspicuous nature of Tel-Me-Box, along with its ability to deliver tailored reminder features honors participants' privacy concerns. Since this electronic device monitoring cannot assess actual drug ingestion, validating it against a biological measure of adherence, such as ARV hair concentrations, is crucial. This study has the following 3 aims: Aim 1 will further refine Tel-Me-Box by reducing its size and adding tailored reminder features. We will also demonstrate feasibility of hair analysis in RLS by training local staff to conduct the relevant hair assays. Aim 2 will validate the Tel-Me-Box adherence measure, using ARV hair concentrations and HIV viral load, and examine the predictive utility of Tel-Me-Box monitoring and hair drug levels on virologic suppression in HIV- infected patients. In Aim 3, we will conduct a pilot RCT to examine acceptability and feasibility and to estimate the effect size of automated tailored real-time adherence reminders on hair ARV concentrations, device- monitored adherence, and viral load suppression in adherence-challenged patients. At study completion, we expect to have validated Tel-Me-Box as an innovative tool to assess adherence and predict treatment outcomes and demonstrated the feasibility of hair analyses in RLS. If successful, we will also have collected pilot data on the efficacy of the Tel-Me-Box automated, tailored reminders for a future large scale RCT.

 描述（由适用提供）：迫切需要实时监测对HIV治疗的新颖，经过验证的方法，以给出众所周知的自我报告粘附，药丸计数和药物电子监测系统（MEMS）盖的局限性。为了在资源丰富和资源有限的设置中具有可扩展性和可持续性，此类设备必须低成本，并以不会增加意外HIV披露和随后的污名的风险。既可以实时监测依从性的设备，又向患者提供量身定制的提醒，可以极大地改善对HIV治疗以及其他慢性疾病的治疗。我们的Indo-US合作团队一直在进行有关HIV污名，ARV依从性模式和障碍，治疗结果和耐药性的研究。我们还开创了在小头发样品中使用ARV浓度的使用，以测量资源丰富和有限的设置（RLS）中的长期ARV依从性。为了应对新型依从性的需求，我们的团队最近开发了Tel-Me-box，这是一种小型，低成本的依从设备，通过在打开时将无线信号传输到服务器，可以实时监视依从性。现在，我们建议添加硬件，使服务器软件能够无线编程设备以激活量身定制的药物提醒（通过哔哔声，振动或LED灯），之后不活动。该设备适合口袋，可以容纳1-2周的药物，电池寿命较长，充电能力简单，并且在试点研究中遵守挑战的印度患者可以接受。由于艾滋病毒的污名是在包括印度在内的许多情况下遵守ARV的深刻障碍，因此Tel-Me-box的小巧，不起眼的性质，以及其提供量身定制的提醒功能的能力。 由于该电子设备监测无法评估实际的药物摄入，因此对依从性的生物学量度（例如ARV头发浓度）进行验证至关重要。这项研究具有以下3个目标：AIM 1将通过降低其尺寸并添加量身定制，进一步完善ME-Box 提醒功能。我们还将通过培训当地员工进行相关的头发评估来证明RLS中头发分析的可行性。 AIM 2将使用ARV头发浓度和HIV病毒载量来验证Tel-Me-Box依从性度量，并检查Tel-Me-box监测和毛发药物水平对HIV感染患者病毒学抑制的预测效用。在AIM 3中，我们将进行试点RCT，以检查可接受性和可行性，并估算自动量身定制的实时依从性提醒对头发ARV浓度，设备监测的依从性以及依从性促进患者的病毒载荷抑制的效果。在研究完成时，我们预计将验证Tel-Me-box作为一种创新工具，以评估依从性和预测治疗结果，并证明RLS中发型分析的可行性。如果成功的话，我们还将收集有关电路盒自动化，量身定制的提醒的有效性的试点数据，以实现未来的大规模RCT。