Automated Medication Platform with Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients with HIV/AIDS

具有视频观察和面部识别功能的自动化用药平台，可提高艾滋病毒/艾滋病患者抗逆转录病毒治疗的依从性

• 批准号: 10256239
• 负责人: Charles Gellman
• 金额: $ 23.48万
• 依托单位: HIDO TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256239
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adherence; Age-Years; Agreement; Anti-Retroviral Agents; Artificial Intelligence; Benchmarking; CD4 Positive T Lymphocytes; Cell Count; Cellular Phone; Cessation of life; Chronic Disease; Clinical Research; Clinical Trials; Consumption; Data; Death Rate; Dementia; Development; Devices; Diagnosis; Disease; Dose; Drug Monitoring; Event; Exclusion Criteria; Face; Feedback; Gold; HIV; Institution; Interview; Legal patent; Liquid substance; Marijuana; Measurement; Measures; Mediation; Medical Device; Methods; Monitor; Participant; Patient Rights; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacy facility; Phase; Privatization; Publishing; Regimen; Reporting; Research Personnel; Savings; Secure; Structure; Study Subject; Sum; System; Technology; Testing; Therapeutic; Therapy trial; Time; Viral; Viral Load result; Writing; adherence rate; antiretroviral therapy; cost; dashboard; illicit drug use; improved; inclusion criteria; medication administration; medication compliance; pill; primary endpoint; promoter; recruit; screening; study population; success; trend; usability; user-friendly; wireless fidelity

Antiretroviral therapy (ART) is directly responsible for reducing the death rate from HIV/AIDS. AIDS-related deaths declined by 38% from 2000 to 2017—saving more than 11 million lives worldwide. Mediation adherence is critically important to this statistic and to clinical trials. Investigators insist on (or assume) adherence rates of ≥95%. However, when bodily fluid measurements are used to assess adherence, the values are substantially lower: 54% to 68%. Viral suppression generally requires most ART be taken with at least 95% adherence. Poor adherence to ART during a clinical trial can underestimate efficacy, increase subject discontinuation rates, and extend recruitment periods and the total duration of clinical trials. This is expensive for clinical trial sponsors and slows or halts the development of antiretrovirals. Direct observation is the gold standard for medication adherence but is prohibitively expensive and impractical. HiDO is an automated AI-driven direct observation medication adherence platform. The platform is a 510K-exempt, Class I medical device with a provisional patent that integrates medication dispensing, pill count and a front-facing video cameras to confirm the right medications are given at right time to the right patient. Investigators have access to video observation logs, patient dose time, adherence trends, and study-level adherence through the platform’s dashboard. Data is stored securely in the cloud and accessible real-time. The device dispenses up to 7 different types of medications simultaneously, 40 doses each. During the 90-day study, participants will receive smartphone reminders; pills will be dispensed through the unit and adherence monitored and verified through video observation and facial recognition. Our benchmark for success is that all participants who complete the study will achieve ≥95% adherence to ART averaged across 90 days (Milestone 1). Adherence will be quantified as the (no. of doses provided — no. of doses taken) / the no. of doses provided X 100. We will further confirm adherence by reviewing patient charts for viral load and CD4 T-cell count. In the same study population described above, we will conduct full usability testing at 2 weeks of use. We will measure Time on Task for initial registration, “first click” testing, facial recognition setup, and medication administration, and assess the number and type of critical and non-critical errors and error-free rate. Results of usability testing will be equal to or better than published benchmark rates for similar platforms (Milestone 2). Subjects will complete the 10-item System Usability Scale (SUS) and achieve an average SUS score >68 (Milestone 3). More than 80% of subjects will have Likely or Strongly Likely Net Promoter Score (Milestone 4). If successful, we will have demonstrated that our automated medication adherence platform is highly usable and user-friendly, enables strict adherence to ART trials, and is ready for testing in Phase II.

抗逆转录病毒疗法是降低艾滋病毒/艾滋病死亡率的直接原因。aids相关 从2000年到2017年，死亡人数下降了38%，在全球范围内挽救了1100多万人的生命。坚持调解 对这个统计数据和临床试验都至关重要。研究者坚持（或假设） ≥ 95%。然而，当使用体液测量来评估依从性时，所述值基本上是不一致的。 较低：54%至68%。病毒抑制通常需要大多数ART至少95%的依从性。 临床试验期间对ART的依从性差可能低估疗效，增加受试者的停药率 率，并延长招募期和临床试验的总持续时间。这对于临床试验来说是昂贵的 赞助并减缓或停止抗逆转录病毒药物的开发。直接观察是 药物治疗依从性差，但过于昂贵和不切实际。HiDO是一个自动化的人工智能驱动的直接 观察服药依从性平台。该平台是510 K豁免的I类医疗器械， 临时专利，集成了药物分配，药丸计数和前置摄像头，以确认 正确的药物在正确的时间给正确的病人。调查人员可以通过视频观察 日志、患者给药时间、依从性趋势和研究水平依从性。数据 安全地存储在云端，可实时访问。该设备可分配多达7种不同类型的 同时服用，每剂40剂。在为期90天的研究中，参与者将获得智能手机 提醒;药丸将通过该单位分发，并通过视频监测和验证依从性 观察和面部识别我们成功的基准是所有完成研究的参与者 将在90天内平均达到≥95%的ART依从性（里程碑1）。依从性将被量化为 （提供的剂量数-服用的剂量数）/提供的剂量数× 100。我们将进一步确认 通过审查患者的病毒载量和CD 4 T细胞计数图表来评估依从性。在同一研究人群中， 如上所述，我们将在使用2周时进行全面的可用性测试。我们将测量任务时间， 初始注册，“首次点击”测试，面部识别设置和药物管理，并评估 关键和非关键错误的数量和类型以及无错误率。可用性测试的结果将等于 或优于类似平台的已公布基准利率（里程碑2）。受试者将完成10项 系统可用性量表（SUS），并达到平均SUS得分>68（里程碑3）。80%以上 受试者将具有可能或非常可能的净启动子评分（里程碑4）。如果成功，我们将 证明了我们的自动化药物依从性平台是高度可用和用户友好的， 严格遵守ART试验，并已准备好进行第二阶段测试。