N/A
N=7
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT05454514 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Rate of Medication Adherence — 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HiDO medication adherence platform (Device); Automated Medication Platform with Video Observation (Device); Time on Task (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Charles Gellman
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Medication Adherence |
2; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05454514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.