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.