CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
HiDO medication adherence platform +2 moredevice
Likely dose
Not stated in record
Key inclusion· 5
  • Age 18–65 years
  • Currently prescribed at least one antiretroviral therapy (ART)
  • Self-reported difficulty with medication adherence
  • Access to personal smartphone and WiFi connection
Key exclusion· 5
  • Illicit drug use within past 6 months (marijuana excluded from restriction)
  • Diagnosis of dementia
  • Participation in clinical study within previous 3 months
  • ART regimen changed within previous 2 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05454514
NCT05454514N/ACompleted

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

Charles Gellman·interventional·Posted Jul 12, 2022·Updated Mar 14, 2025

In Brief

A clinical study evaluating HiDO medication adherence platform, Automated Medication Platform with Video Observation, and 1 other intervention for HIV Infections. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 12, 2022
Enrollment StartSep 9, 2021
Primary CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.0 years ago

Interventions

HiDO medication adherence platformdevice

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.

Automated Medication Platform with Video Observationdevice

There is no drug intervention. The device elicits increases adherence of medications.

Time on Taskother

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.