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.

抗逆转录病毒治疗（ART）直接负责降低艾滋病毒/艾滋病相关的死亡率。 从 2000 年到 2017 年，死亡人数下降了 38%——遵守调解在全球挽救了超过 1100 万人的生命。 对于这一统计数据和临床试验来说至关重要。 然而，当使用体液测量来评估依从性时，该值相当大 较低：54% 至 68%，病毒抑制通常要求大多数 ART 的依从性至少为 95%。 临床试验期间 ART 依从性差可能会低估疗效，增加受试者中止治疗的可能性 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是黄金标准。 HiDO 是一种自动化的人工智能驱动的直接疗法，但价格昂贵且不切实际。 该平台是一种 510K 豁免的 I 类医疗设备，具有 临时专利，集成了药物分配、药丸计数和前置摄像头以确认 研究人员可以在正确的时间向正确的患者提供正确的药物观察。 通过平台数据显示日志、患者剂量时间、依从性趋势和研究级别依从性。 安全地存储在云端并可实时访问 该设备可分配多达 7 种不同类型的物质。 在为期 90 天的研究中，参与者将同时服用 40 剂药物。 提醒；药丸将通过该单位分发，并通过视频监控和验证依从性 我们成功的标准是所有完成研究的参与者。 将在 90 天内达到 ≥95% 的平均 ART 依从性（里程碑 1）。 （提供的剂量数 - 服用的剂量数）/提供的剂量数 X 100。我们将进一步确认 通过查看同一研究人群中的病毒载量和 CD4 T 细胞计数的患者图表来确定依从性。 如上所述，我们将在使用两周后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的结果将等于。 或优于已发布的类似平台基准费率（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 分数 >68（里程碑 3）超过 80%。 受试者将具有可能或极可能的净推荐值（里程碑 4）。如果成功，我们将获得。 我们的自动化药物依从平台具有高度可用性和用户友好性，使得 严格遵守ART试验，并已准备好进行第二阶段的测试。