Measuring and Monitoring Adherence to ART with Pill Ingestion Sensor System

使用药丸摄入传感器系统测量和监测 ART 的依从性

• 批准号: 9751390
• 负责人: ERIC S DAAR
• 金额: $ 67.98万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-23 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9751390
• 关键词: Activities of Daily Living; Address; Adherence; Anti-Retroviral Agents; Biological Availability; Bluetooth; CD4 Lymphocyte Count; Cellular Phone; Clinic; Clinical; Data; Data Collection; Directly Observed Therapy; Disease Management; Dose; Drops; Encapsulated; European; European Union; Event; FDA approved; Feedback; Formulation; Fostering; Goals; HIV; HIV Infections; Health; Ingestion; Intake; Intervention; Liquid substance; Measures; Medical center; Methods; Monitor; Notification; Outcome; Participant; Patient Self-Report; Patients; Pattern; Pharmaceutical Preparations; Plasma; Process; Proteus; Randomized; Research; Safety; Schedule; Sensitivity and Specificity; Signal Transduction; Specific qualifier value; Standardization; Stomach; Suggestion; System; Testing; Text Messaging; Time; Viral Load result; antiretroviral therapy; base; design; digital; effective intervention; follow-up; handheld mobile device; improved; in vivo monitoring; medication compliance; microchip; pill; public health relevance; real time monitoring; recruit; sensor; therapy adherence; treatment as usual

 DESCRIPTION (provided by applicant): Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to manageable disease but adherence to ART remains critical to optimize outcomes. Existing measures of ART adherence such as self-report, pill counts, electronic pill-bottle caps, and prescription refills, provide only inferred measures of actual drug intake and most offer no real-time notification capability. Directly observed therapy measures actual drug intake but is not practical. These limitations constrain research into medication adherence and more importantly, limit our ability to develop real-time interventions based on feasible, in vivo monitoring of adherence among HIV-infected people to facilitate medication-taking. The Proteus digital health feedback (PDHF) system, a pill ingestible sensor based adherence measuring and monitoring system developed by Proteus Digital Health, addresses these limitations. It involves use of an ingestible sensor, a tiny edible material that i over-encapsulated along with prescribed medication. The sensor is activated by ingestion and is sensed by a patch worn by the patient with an embedded monitor and sensor. The monitor sends a Bluetooth signal to a mobile device, which in turn sends an encrypted message to a central server, thus effecting real-time monitoring that a dose has been taken. We propose to develop a data receiving hub and add to these components an automated text message that is sent to the patient when a dose is missed. The ingestible sensor and patch monitor system is already FDA-approved as safe, but has yet to be tested in HIV- infected patients in clinical setting. The first goals of this study are to confirm the bioavailability of over- encapsulated antiretrovirals (ARVs) and to pilot-test the use of the PDHF system in 15 participants prescribed ARVs to test and identify approaches that optimize the use of this measuring and monitoring system. The next goals are to determine the system's feasibility, acceptability, sustainability, accuracy and efficacy in fostering ART adherence. Feasibility, acceptability and sustainability will be assessed by patients' rating of the system and the rate of dropping off from using the system. Accuracy will be evaluated by the associations between adherence to ART measured by the PDHF system and other adherence measures such as plasma drug level concentrations of ARVs and self-report. Efficacy will be assessed by comparing adherence of participants assigned to the PDHF system and participants assigned to usual care (UC) over time, with exploratory outcomes of viral load and CD4. We will recruit 120 of HIV-infected patients 18 years or older with sub-optimal adherence. Participants will be randomized to receive the PDHF system or UC for 16 weeks with monthly assessments. The durability of effects of the PDHF system after stopping the use of the system will be determined during a 12-week follow-up stage. In summary, we will evaluate the feasibility, acceptability and sustainability of using the PDHF system; assess the accuracy of the PDHF system in measuring adherence to ART; and evaluate the efficacy of the PDHF system for monitoring and leveraging adherence to ART. 1

 描述（适用提供）：引入抗逆转录病毒疗法（ART）已将HIV感染从致命的疾病转变为可管理的疾病，但对艺术的依从性对于优化结果仍然至关重要。现有的艺术依从性措施，例如自我报告，药丸计数，电子药瓶盖和处方补充，仅提供推断的实际药物摄​​入量措施，并且大多数不提供实时通知能力。直接观察到的治疗方法可以测量实际的药物摄入量，但不切实际。这些局限性将研究限制在药物依从性上，更重要的是，我们限制了我们基于可行的，体内监测HIV感染者依从性的实时干预措施以促进药物治疗的能力。 Proteus数字健康反馈（PDHF）系统是一种基于Proteus Digital Health开发的基于药丸的依从性测量和监测系统，可以解决这些限制。它涉及使用可观的传感器，这是我与处方药一起过度封装的微小食用材料。传感器通过摄入激活，并通过嵌入式监视器和传感器的患者佩戴的贴剂感测。监视器向移动设备发送蓝牙信号，该设备又将加密消息发送到中央服务器，从而有效地进行了剂量的实时监视。我们建议开发一个数据接收枢纽，并添加到这些组件中，一个自动化的短信，当错过剂量时，该消息将发送给患者。可观的传感器和斑块监视器系统已经被FDA批准为安全，但尚未在临床环境中的HIV感染患者中进行测试。这项研究的第一个目标是确认过度封装的抗逆转录病毒（ARV）的生物利用度，并试点测试PDHF系统在15名参与者规定的ARV中使用，以测试和识别优化该测量和监测系统使用的方法。下一个目标是确定系统在促进艺术依从性方面的可行性，可接受性，可持续性，准确性和效率。可行性，可接受性和可持续性将由患者的系统评级以及使用系统下降的速度评估。通过遵守PDHF系统测量的ART与其他依从性测量（例如ARV的血浆药物水平浓度和自我报告）之间的关联，将评估准确性。将通过比较分配给PDHF系统的参与者的依从性，并随着时间的推移将分配给常规护理（UC）的参与者与病毒负载和CD4的探索结果进行比较。我们将招募18岁或以上遵循的18岁以上的HIV感染患者。参与者将被随机接收PDHF系统或UC 16周，并通过每月评估。停止使用系统后，PDHF系统的效果持久性将在12周的随访阶段确定。总之，我们将评估使用PDHF系统的可行性，可接受性和可持续性；评估PDHF系统在测量遵守ART方面的准确性；并评估PDHF系统的效率，以监视和利用对艺术的遵守。 1