DOT Diary (D2): Developing a mobile app with combined automated DOT and daily sexual diary for monitoring and improving PrEP adherence

DOT 日记 (D2)：开发一款结合自动化 DOT 和每日性日记的移动应用程序，用于监测和提高 PrEP 依从性

• 批准号: 9147007
• 负责人: Susan Buchbinder
• 金额: $ 86.12万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-21 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9147007
• 关键词: Accounting; Adherence; Anti-Retroviral Agents; Artificial Intelligence; Behavior; Biological; Blood; Blood specimen; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Color; Computer software; Data; Data Aggregation; Data Collection; Directly Observed Therapy; Dose; Drug Kinetics; Effectiveness; Ensure; Evaluation; FDA approved; Face; Feedback; Frequencies; Fumarates; Future; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; Health; Incidence; Individual; Infection; Infection prevention; Ingestion; Injectable; Interruption; Intervention; Legal patent; Measurement; Measures; Medicine; Monitor; Oral; Participant; Patients; Pattern; Performance; Persons; Pharmaceutical Preparations; Pilot Projects; Process; Prophylactic treatment; Protocols documentation; Recommendation; Regimen; Reporting; Risk; Running; San Francisco; Schedule; Sex Behavior; Sexual Partners; Site; Spottings; Staging; Technology; Tenofovir; Testing; Time; United States; Validity and Reliability; Vulnerable Populations; antiretroviral therapy; comparative efficacy; cost; dashboard; diaries; efficacy trial; emtricitabine; forgetting; high risk; improved; meetings; men who have sex with men; mobile application; new technology; pill; pre-clinical; prevent; programs; sex risk; temporal measurement; tool; treatment adherence; tuberculosis treatment; volunteer; young man

 DESCRIPTION (provided by applicant): Several efficacy trials of pre-exposure prophylaxis (daily antiretroviral therapy to prevent HIV acquisition in uninfected persons with sexual exposures) have failed because of poor adherence to medications. To ensure accurate, longitudinal measurement of pill ingestion with real-time monitoring, we plan to develop DOT Diary (D2), a smartphone application that uses artificial intelligence for measuring pill taking using Directly Observed Therapy. This patented technology will be combined with a daily sexual diary for use in future PrEP observational and efficacy trials. Such an approach provides aggregated data for individual participants, study sites, and trials overall, that facilitates realtime feedback to maximize adherence. We plan a 3 stage process for building and evaluating D2. First, we will assess the assess the reliability and validity of the automated DOT tool to identify attempts to "cheat" and over-report pill taking, as well as to evaluate the sensitivity of the measure to detecting 1- to 3-week interruptions in pill use. Second, we will develop and optimize the feasibility and acceptability of D2 for participants and study staff in tracking participation ver time, and providing real-time adherence feedback to study participants. Lastly, we will run a 24-week pilot study of D2 for high-risk men who have sex with men to evaluate the plausibility that this tool can be successfully used to measure and optimize adherence in future PrEP trials.