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

NCT05454514 | Completed Results FDA Device

• 1 other identifier: R43MH125483-01A1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Automated Medication Platform with Video Observation

OTHER

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

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

Interventions

HiDO medication adherence platform DEVICE

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 Observation

Automated Medication Platform with Video Observation DEVICE

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

Automated Medication Platform with Video Observation

Time on Task OTHER

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.

Automated Medication Platform with Video Observation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Gellman: lead

Study Sites (1)

HiDO Technologies Inc.

El Dorado Hills, California, 95762, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Charles Gellman, CEO
• Organization: HIDO TECHNOLOGIES, INC.

charles@hidohealth.com

5108137224

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a randomized, unblinded, Phase 1 study of the HiDO automated medication adherence platform in patients ages 18 to 65 with HIV/AIDS who are currently taking ART. For this single-site device study, clinical collaborators will recruit 24 subjects into a single study group. After a screening period of up to 14 days, subjects will receive the 90-day intervention that consists of using of an automated medication adherence platform. Medication adherence will be assessed through observed therapy using front-facing cameras on the device. Corroborating data will be drawn from viral load data.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 12, 2022
• Study Start: September 9, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)