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

 描述（由申请人提供）：在过去十年中，通过使用高效抗逆转录病毒（ARV）治疗，HIV-1感染已转变为一种慢性疾病。最近的研究表明，用作预防艾滋病毒感染的暴露前预防（PrEP）的ARV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严格按照处方服药（依从性）。迄今为止，还没有可靠、准确的抗逆转录病毒药物依从性衡量标准。该提案将评估使用一种新的传感器平台，称为数字健康反馈系统（DHFS）的真实的时间坚持监测艾滋病毒感染者开始抗逆转录病毒药物和艾滋病毒感染的高危人群开始PrEP. Aim 1：开发选定的数字化抗逆转录病毒药物用于DHFS。 我们将联合收割机与常用的抗逆转录病毒药物结合在一起，使DHFS能够检测到一个人何时服用药物。成果将包括成功开发一个“数字化”的抗逆转录病毒药物组，与DHFS一起使用，这些药物根据USP指南进行了测试，在临床环境中使用安全。 目的2：评价DHFS在初始抗逆转录病毒治疗依从性纵向监测中的使用、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感染者是否可以接受DHFS。结果包括可接受性（通过验证的问卷和参与者的持续使用来测量）、DHFS的阳性检测准确性（通过在研究访视时直接观察到的摄入量来测量）和药物依从性（通过DHFS来测量）。 目的3：评价DHFS用于HIV暴露前预防（PrEP）中使用的ARV纵向监测的可接受性、有效性和实用性。 我们将评估DHFS是否可接受的人在艾滋病毒感染的高风险，正在启动PrEP。结果包括可接受性，通过有效的问卷调查和持续使用的参与者，积极的检测准确性DHFS测量直接观察到的摄入量在研究访视，和药物依从性DHFS测量。

 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.