Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This is a 90-day medication adherence study testing the HiDO is an automated AI-driven direct
      observation medication adherence platform, which is a 510K-exempt, Class I medical device
      with 24 people with HIV/AIDS, ages 18 to 55, who are currently taking ART and reporting less
      than 100% adherence. The aims of the study are to see whether the device can achieve >95% ART
      adherence among all participants averaged over 90 days and to perform usability testing using
      the System Usability Scale and Net Promoter scores.
    

Detailed description: 
      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 smart phone 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. The investigators will
      further confirm adherence by reviewing patient charts for viral load and CD4 T-cell count. In
      the same study population described above, the investigators will conduct full usability
      testing at 2 weeks of use. The investigators 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, the investigators
      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.
    

Intervention name(s): HiDO medication adherence platform; Automated Medication Platform with Video Observation; Time on Task
Intervention type(s): Device; Device; Other
Intervention description(s): The HiDO medication adherence platform will be shipped directly to the home of record of each participant. The Primary Endpoint is medication adherence as assessed by remote observation through the HiDO device at 90 days.; There is no drug intervention. The device elicits increases adherence of medications.; Other Endpoints include Time on Task for initial registration, "first click" testing, facial recognition setup, medication administration, number and type of critical and non-critical errors and error-free rate, System Usability Scale (SUS), and Net Promoter Score.
Intervention model: Single Group Assignment
Intervention model description: HiDO is an automated Artificial Intelligence driven direct observation medication adherence platform. The platform is a 510K exempt Class I medical device that integrates medication dispensing, dose administration time, pill count and front facing video cameras to validate the right medications, at right time to the right patient. The device dispenses up to 7 different types of medications simultaneously. The camera logs every dose using facial recognition and provides real time consumption logs. Investigators have access to video observation logs, patient dose time, adherence trends, and study level adherence measures.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV