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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Device: HiDO medication adherence platform; Device: Automated Medication Platform with Video Observation; Other: Time on Task

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • El Dorado Hills, California, United States, 95762
      • HiDO Technologies Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Automated Medication Platform with Video Observation; There is no drug intervention. The device elicits increases adherence of medications.

Device: HiDO medication adherence platform; 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.; Device: Automated Medication Platform with Video Observation; There is no drug intervention. The device elicits increases adherence of medications.; Other: Time on Task; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Medication Adherence	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.	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

Collaborators and Investigators

• Sponsor: Charles Gellman

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: R43MH125483-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will not be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes