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

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Device: HiDO medication adherence platform
Device: Automated Medication Platform with Video Observation
Other: Time on Task

Registration Number: NCT05454514

Lead Sponsor: Charles Gellman

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Automated Medication Platform with Video Observation	HiDO medication adherence platform	There is no drug intervention. The device elicits increases adherence of medications.
Automated Medication Platform with Video Observation	Automated Medication Platform with Video Observation	There is no drug intervention. The device elicits increases adherence of medications.
Automated Medication Platform with Video Observation	Time on Task	There is no drug intervention. The device elicits increases adherence of medications.

Primary Outcome Measures

Name	Time	Method
Rate of Medication Adherence	90 days	The primary endpoint was to determine the number of participants who achieved 80-95% adherence to ART medications averaged across 90 days (Milestone 1). The benchmark for success was set at all participants completing the study achieving adherence within this range. Adherence rates were calculated as the number of doses provided minus the number of doses missed, divided by the total number of doses provided, multiplied by 100.

Secondary Outcome Measures