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 adherenceis critically important to this statistic and to clinical trials. Investigators insist on (or assume) adherence rates ofâ¥95%. However, when bodily fluid measurements are used to assess adherence, the values are substantiallylower: 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 discontinuationrates, and extend recruitment periods and the total duration of clinical trials. This is expensive for clinical trialsponsors and slows or halts the development of antiretrovirals. Direct observation is the gold standard formedication adherence but is prohibitively expensive and impractical. HiDO is an automated AI-driven directobservation medication adherence platform. The platform is a 510K-exempt, Class I medical device with aprovisional patent that integrates medication dispensing, pill count and a front-facing video cameras to confirmthe right medications are given at right time to the right patient. Investigators have access to video observationlogs, patient dose time, adherence trends, and study-level adherence through the platform's dashboard. Datais stored securely in the cloud and accessible real-time. The device dispenses up to 7 different types ofmedications simultaneously, 40 doses each. During the 90-day study, participants will receive smartphonereminders; pills will be dispensed through the unit and adherence monitored and verified through videoobservation and facial recognition. Our benchmark for success is that all participants who complete the studywill achieve â¥95% adherence to ART averaged across 90 days (Milestone 1). Adherence will be quantified asthe (no. of doses provided - no. of doses taken) / the no. of doses provided X 100. We will further confirmadherence by reviewing patient charts for viral load and CD4 T-cell count. In the same study populationdescribed above, we will conduct full usability testing at 2 weeks of use. We will measure Time on Task forinitial registration, "first click" testing, facial recognition setup, and medication administration, and assess thenumber and type of critical and non-critical errors and error-free rate. Results of usability testing will be equal toor better than published benchmark rates for similar platforms (Milestone 2). Subjects will complete the 10-itemSystem Usability Scale (SUS) and achieve an average SUS score >68 (Milestone 3). More than 80% ofsubjects will have Likely or Strongly Likely Net Promoter Score (Milestone 4). If successful, we will havedemonstrated that our automated medication adherence platform is highly usable and user-friendly, enablesstrict adherence to ART trials, and is ready for testing in Phase II.
Public Health Relevance Statement: Project Narrative
Anti-retroviral therapy can suppress HIV, stop the progression to AIDS, and save lives; however, the
medications must be taken as prescribed. Our automated, artificially intelligent, video-confirmed medication
adherence device can help increase adherence to HIV medications and achieve lasting viral suppression,
turning a deadly disease into a tolerable, chronic illness.
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