A Novel Wireless Ingestible Sensor System for Measurement of medication Adherence in HIV Treatment and Prevention

项目总结/摘要 当前的远程移动的健康监测使用经由集线器连接到移动的电话或因特网的外围设备。一 已经开发了被称为"重要案例系统"（Vital-Case System，缩写为VCA）的智能手机案例系统，其允许可重复使用电池 手机生物传感器，以获得温度，HR和SpO2的准确生命体征测量值，以及嵌入在 外壳本身允许心电图（ECG）阅读（Maxim Integrated，CA）。直接使用嵌入式智能手机 由壳体实现的生物传感器，其还能够实现ECG阅读，是非常新颖的，并且具有深远的影响，并且可以 在使远程生命体征监测可用于低资源设置方面具有实质性用途。该提案扩大了 R01MH110057 "表征抗逆转录病毒治疗依从性的新型可食用传感器系统"，以验证生命体征 在HIV感染者和未感染HIV的高危人群中进行测量。 研究提案还包括在母研究R01 MH110057中增加探索性干预研究组， 探索DHFS对住院HIV感染者的可接受性及其支持其药物依从性的效用 出院后。 目的1：评价该量表的有效性、使用性和可接受性。我们将进行单组受试者内设计 主要使用R01 MH-110057的参与者进行干预。我们将确定和验证的准确性， 与市售的"黄金"标准Welch Allyn仪器相比， 参与者在诊所，门诊和家庭环境。将招募40名参与者的子集使用该工具 在参与母研究R01期间，在家中独立进行生命体征测量。在 此外，在阻塞性睡眠呼吸暂停（OSA）的睡眠实验室测试期间，将招募20名参与者，以验证 在低SpO2的门诊环境中测量SpO2和HR。主要终点将是确定和 通过比较重要的， 在同一个参与者中签名。 目的2：探讨DHFS在HIV感染者住院治疗后的可接受性和实用性。 出院 我们将对30例血浆HIV RNA可检测的住院HIV感染者进行干预研究。 受试者将在住院期间使用DHFS入组一项为期16周的干预研究。一旦出院， 参与者将继续使用DHFS。DHFS将记录抗逆转录病毒药物摄入的纵向模式 在研究期间，该系统将用于获得依从性的准确测量。适应性设计 将遵循：根据每日生成的DHFS，任何ARV依从性低于90%的受试者将获得依从性支持 摄取数据。主要终点将是DHFS捕获的摄入剂量数与 在这一人群中使用的剂量。

PROJECT SUMMARY / ABSTRACT Current remote mobile health monitoring uses peripheral devices that connect to a mobile phone or Internet via a hub. A smartphone case system, designated “Vital-Case System” (VCS), has been developed that allows repeatable use of cell phone biosensors to obtain accurate vital signs measurements of temperature, HR, and SpO2, and electrodes embedded in the case itself allow electrocardiogram (ECG) reading (Maxim Integrated, CA). Direct use of smartphone embedded biosensors enabled by a case, which also enables ECG reading is highly novel and has far reaching implications and may be of substantial use in making remote vital sign monitoring available to low resource settings. This proposal expands the R01MH110057 “A Novel Edible Sensor System to Characterize Antiretroviral Therapy Adherence” to validate vital sign measurement via VCS in HIV-infected and high-risk HIV-uninfected populations. The research proposal also includes the addition of an exploratory intervention study arm to the parent R01 MH110057 to explore DHFS acceptability to hospitalized HIV-infected subjects and its utility to support their medication adherence post hospital discharge. Aim 1: Evaluate the validity, use and acceptability of the VCS. We will conduct a single arm within-subject design intervention using primarily participants of R01 MH-110057. We will determine and validate the accuracy of the VCS vital sign measurements compared to that of commercially available ‘gold’ standard Welch Allyn instruments in participants in the clinic, outpatient and home setting. A sub-set of 40 participants will be recruited to use the VCS independently at home, to obtain vital sign measurements for the duration of their participation in the parent R01 study. In addition, 20 participants will be recruited during Sleep Laboratory testing of Obstructive Sleep Apnea (OSA) to validate measurements of SpO2 and HR in an outpatient setting of low SpO2. The primary end point will be to determine and validate the inter- and intra-machine accuracy of VCS and the ‘gold’ standard Welch Allyn devices by comparing vital signs in the same participant. Aim 2: Explore the acceptability and utility of the DHFS use in hospitalized HIV infected participants post- hospital discharge We will conduct an intervention study on 30 hospitalized HIV infected Subjects with detectable plasma HIV RNA. Subjects will be enrolled into a 16 week intervention study using the DHFS whilst still in hospital. Upon discharge, participants will continue use of DHFS. Longitudinal patterns of ARV medication ingestion will be captured by the DHFS for the duration of the study and the system will be used to derive an accurate measure of adherence. An adaptive design will be followed: any Subject under 90% ARV adherence receive adherence support based on daily DHFS generated ingestion data. The primary end points will be the number of doses ingested captured by the DHFS over the number of doses prescribed in this population.