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

 描述(由申请人提供)：过去十年的进步通过使用高效抗逆转录病毒(ARV)疗法将艾滋病毒-1感染转变为一种慢性病。最近的研究表明，用于预防艾滋病毒感染的暴露前预防(PrEP)的抗逆转录病毒药物有可能改变艾滋病毒的流行。然而，抗逆转录病毒药物在治疗和预防艾滋病毒方面的成功关键取决于完全按照处方服药(坚持)。到目前为止，还没有可靠、准确的ARV依从性测量方法。这项提案将评估一种名为数字健康反馈系统(DHFS)的新型传感器平台在开始抗逆转录病毒药物的艾滋病毒感染者和开始PrEP的艾滋病毒感染高危人群中实时监测依从性的使用情况。目标1：开发用于DHFS的选定数字化抗逆转录病毒药物。我们将在凝胶中将可食用传感器与常用的抗逆转录病毒药物结合起来，使DHFS能够检测到患者何时服用药物。结果将包括成功开发与DHFS一起使用的“数字化”抗逆转录病毒药物小组，这些药物根据USP指南进行测试，并可在临床环境中安全使用。目的2：评估DHFS在ARV初始治疗期间对依从性的纵向监测的使用、可接受性、有效性和实用性。我们将评估首次开始抗逆转录病毒治疗的艾滋病毒携带者是否可以接受DHFS。结果包括通过有效问卷和参与者持续使用来衡量的可接受性，通过在研究访问中直接观察到的摄入量来衡量DHFS的阳性检测准确性，以及通过DHFS来衡量药物依从性。目的3：评价DHFS用于HIV暴露前预防(PrEP)中抗逆转录病毒药物纵向监测的可接受性、有效性和实用性。我们将评估DHFS是否可以被启动PrEP的艾滋病毒感染高危人群接受。结果包括通过有效问卷衡量的可接受性和参与者使用的持续性，通过在研究访问中直接观察到的摄入来衡量DHFS的阳性检测准确性，以及通过DHFS衡量的药物依从性。

 DESCRIPTION (provided by applicant): Advances in the last decade have transformed HIV-1 infection into a chronic disease through the use of highly active antiretroviral (ARV) therapy. Recent studies suggest the ARVs used as pre-exposure prophylaxis (PrEP) to prevent HIV infection have the potential to transform the HIV pandemic. However, the success of ARVs in both the treatment and prevention of HIV is critically dependent on taking medications exactly as prescribed (adherence). To date, no reliable, accurate measurement for ARV adherence exists. This proposal will evaluate the use of a novel sensor platform termed the Digital Health Feedback System (DHFS) for real- time adherence monitoring in HIV-infected persons starting ARVs and in persons at high risk for HIV infection starting PrEP. Aim 1: Develop selected digitized ARVs for use within the DHFS. We will combine an edible sensor with commonly used ARVs within a gelcap to allow the DHFS to detect when a person takes their medication. Outcomes will include successful development of a `digitized' panel of ARVs to use with the DHFS, which are tested against USP guidelines and safe for use in clinical settings. Aim 2: Evaluate the use, acceptability, validity, and utility of the DHFS for longitudinal monitoring of adherence during initial ARV therapy. We will assess if the DHFS is acceptable to persons living with HIV that are initiating ARV treatment for the first time. Outcomes include acceptabilit as measured through validated questionnaires and persistence of use by participants, positive detection accuracy of the DHFS as measured by directly observed ingestions at study visits, and medication adherence as measured by DHFS. Aim 3: Evaluate the acceptability, validity, and utility of the DHFS for longitudinal monitoring of ARVs used in HIV pre-exposure prophylaxis (PrEP). We will assess if the DHFS is acceptable to persons at high risk for HIV infection that are initiating PrEP. Outcomes include acceptability as measured through validated questionnaires and persistence of use by participants, positive detection accuracy of the DHFS as measured by directly observed ingestions at study visits, and medication adherence as measured by DHFS.