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

一种新型无线可摄入传感器系统，用于测量艾滋病毒治疗和预防中的药物依从性

基本信息

批准号：
9751389
负责人：
CONSTANCE ANN BENSON
金额：
$ 68.83万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-20 至 2022-07-31
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：过去十年的进展通过使用高效抗逆转录病毒（ARV）疗法已将 HIV-1 感染转变为慢性疾病。最近的研究表明，ARV 可以用作暴露前预防（PrEP）来预防。 HIV 感染有可能改变 HIV 流行趋势，但抗逆转录病毒药物在治疗和预防 HIV 方面的成功关键取决于是否严格按照处方服药（坚持用药）。该提案将评估一种称为数字健康反馈系统（DHFS）的新型传感器平台的使用情况，该平台可用于实时监测开始使用抗逆转录病毒药物的艾滋病毒感染者和艾滋病毒高危人群的依从性。目标 1：开发选定的数字化抗逆转录病毒药物，供 DHFS 使用结果将包括成功开发与 DHFS 一起使用的“数字化”抗逆转录病毒药物组，该药物组已根据 USP 指南进行测试，可安全用于临床环境。目标 2：评估该药物的使用、可接受性、有效性和实用性。 DHFS 用于纵向监测初始 ARV 治疗期间的依从性我们将评估 DHFS 是否适合首次开始 ARV 治疗的 HIV 感染者接受，结果包括通过验证测量的可接受性。目标 3：评估 DHFS 用于纵向监测的可接受性、有效性和实用性。用于 HIV 暴露前预防 (PrEP) 的抗逆转录病毒药物我们将评估 DHFS 是否适合正在启动 PrEP 的 HIV 感染高危人群。通过经过验证的问卷和参与者的使用持续性来衡量，DHFS 的阳性检测准确性通过研究访视时直接观察的摄入量来衡量，以及药物依从性通过 DHFS 来衡量。