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

• 批准号: 9319811
• 负责人: CONSTANCE ANN BENSON
• 金额: $ 95.55万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-20 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9319811
• 关键词: AIDS prevention; Adherence; Anti-Retroviral Agents; Behavior; Chronic Disease; Cities; Clinical; Detection; Development; Directly Observed Therapy; Dose; Drug Exposure; Drug Kinetics; Ensure; Evaluation; FDA approved; Feasibility Studies; Feedback; Future; Goals; Gold; Guidelines; HIV; HIV Infections; HIV-1; Health; Highly Active Antiretroviral Therapy; Individual; Infection; Infection prevention; Ingestion; Intervention; Intervention Studies; Measurement; Measures; Medication Systems; Monitor; Oral; Outcome; Participant; Patients; Pattern; Performance; Persons; Pharmaceutical Preparations; Physiological; Pilot Projects; Plasma; Prevention; Proteus; Questionnaires; Real-Time Systems; Recording of previous events; Redwood; Regimen; System; Tablets; Testing; Time; Viral; Visit; Wireless Technology; antiretroviral therapy; arm; base; digital; experience; high risk; medication compliance; novel; pandemic disease; patient subsets; pharmacokinetic model; pre-exposure prophylaxis; prevent; prevention clinical trial; primary outcome; public health relevance; sensor; success; tool; truvada

 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（由适用提供）：过去十年的进步通过使用高活性抗逆转录病毒（ARV）治疗将HIV-1感染转化为慢性疾病。最近的研究表明，用作防止HIV感染的暴露前预防（PREP）的ARV有可能改变HIV大流行。但是，ARV在艾滋病毒的治疗和预防中的成功取决于完全按照处方服用药物（依从性）。迄今为止，尚无可靠，准确的ARV依从性测量。该提案将评估使用新颖的传感器平台称为数字健康反馈系统（DHFS），以开始艾滋病毒感染者的实时依从性监测，并在患HIV感染的高风险开始准备中。 AIM 1：开发选定的数字化ARV，以在DHF中使用。我们将在胶囊中将可食用的传感器与常用的ARV结合在一起，以使DHFS检测到一个人何时服药。结果将包括成功开发与DHF一起使用的“数字化” ARV面板，该面板已根据USP指南进行了测试，并可以安全用于临床环境。 AIM 2：评估DHF在初始ARV治疗期间纵向监测依从性的使用，可接受性，有效性和效用。我们将评估DHFS首次开始启动ARV治疗的艾滋病毒患者是否可以接受。结果包括通过经过验证的问卷和参与者使用的持续性测量的可接受性，DHF的正阳性检测准确性，如直接观察到的研究就诊时摄入的摄入量，以及通过DHFS测量的药物依从性。 AIM 3：评估DHFS对HIV暴露前预防中使用的ARV的纵向监测的可接受性，有效性和效用（PREP）。我们将评估DHFS是否可以接受启动PREP的艾滋病毒感染的高风险的人。结果包括通过经过验证的问卷和参与者使用的持续性测量的可接受性，DHF的正阳性检测准确性，如直接观察到的研究就诊时摄入的摄入量，以及通过DHFS测量的药物依从性。