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

NCT05454514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-03-14

Study results available
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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.

Conditions

  • HIV Infections

Interventions

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.

Sponsors & Collaborators

  • Charles Gellman

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2023-05-31
Completion
2023-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454514 on ClinicalTrials.gov