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

项目摘要/摘要 当前的远程移动健康监测使用通过集线器连接到移动电话或互联网的外围设备。一个 智能手机的案例系统，被称为“生命案例系统”(VCS)，已经被开发出来，允许重复使用细胞 手机生物传感器，以获得准确的生命体征的温度，心率和SpO2测量，并嵌入电极 外壳本身允许读取心电图(Maxim集成，加利福尼亚州)。直接使用嵌入式智能手机 由病例启用的生物传感器也可以实现心电读取，这是非常新颖的，具有深远的影响，可能 在向资源不足的环境提供远程生命体征监测方面有很大的用处。这项建议扩大了 R01MH110057“一种用于表征抗逆转录病毒治疗依从性的新型可食用传感器系统”验证生命体征 通过VCS对感染艾滋病毒和未感染艾滋病毒的高危人群进行测量。 研究建议还包括在父母R01 MH110057上增加一个探索性干预研究臂，以 探讨DHFS对住院HIV感染者的可接受性及其对支持其用药依从性的作用 出院后。 目的1：评价VCS的效度、使用和可接受性。我们将进行单臂内受试者设计 干预主要使用R01 MH-110057的参与者。我们将确定并验证VCS的准确性 生命体征测量与商业上可买到的‘黄金’标准Welch Allyn仪器的比较 参与者在诊所、门诊和家庭环境中。将招募40名参与者使用VCS 在他们参与父母R01研究期间，在家中独立获得生命体征测量。在……里面 此外，在睡眠实验室测试阻塞性睡眠呼吸暂停(OSA)期间，将招募20名参与者进行验证 低血氧饱和度门诊患者的SpO2和HR测定主要终点将是确定和 通过比较VCS和‘Gold’标准的Welch Allyn设备，验证VCS的机器间和机器内的准确性 在同一参与者中签名。 目的2：探讨DHFS在HIV感染者住院后使用的可接受性和实用性。 出院 我们将对30名可检测到血浆HIV RNA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参加一项为期16周的干预研究。出院后， 参与者将继续使用DHFS。DHFS将捕获抗逆转录病毒药物摄取的纵向模式 在研究期间，该系统将被用于得出遵守情况的准确衡量标准。一种适应性设计 将遵循：任何符合90%ARV遵从率的受试者都将获得基于每日生成的DHFS的遵从性支持 摄取数据。主要终点将是DHFS在以下数量中捕获的摄入量 在这个人群中开出的剂量。

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.