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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Device: HiDO medication adherence platform
* Device: Automated Medication Platform with Video Observation
* Other: Time on Task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age Prescription for at least one existing ART Has expressed difficulty with medication adherence (question screen) Access to a personal smart phone and a Wi-Fi connection Ability to read and write English Exclusion Criteria: Illicit drug use within the past 6 months (excl. marijuana) Diagnosis of dementia Clinical study participation within the previous 3 months Changes to ART regimen within the previous 2 months Anticipated change to ART therapy within the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Automated Medication Platform with Video Observation<br>There is no drug intervention. The device elicits increases adherence of medications. | Device: HiDO medication adherence platform<br>* 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.<br>Device: Automated Medication Platform with Video Observation<br>* There is no drug intervention. The device elicits increases adherence of medications.<br>Other: Time on Task<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Medication Adherence | Medication adherence will be assessed by the number of participants who achieve ≥95% adherence to ART medications, not a comparison to baseline adherence. observed therapy using front-facing cameras on the device. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on Task for Device Usability | Time on Task for initial registration, facial recognition setup, and medication administration, and assess the number and type of critical and non-critical errors and error-free rate. The 5 point Likert scale will be used to rate the 10-item System Usability Scale subjectively. Average System Usability Scale score >68. | 2 weeks, 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV