HIV InfectionsNCT05454514
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
A study testing HiDO medication adherence platform, Automated Medication Platform with Video Observation and Time on Task in people with HIV Infections, run by Charles Gellman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HiDO medication adherence platform, Automated Medication Platform with Video Observation and Time on Task
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
HiDO Technologies Inc.
El Dorado Hills, California, 95762
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- HiDO medication adherence platform, Automated Medication Platform with Video Observation, Time on Task
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Automated Medication Platform with Video Observation | Other | There is no drug intervention. The device elicits increases adherence of medications. Receives: Device: HiDO medication adherence platform; Device: Automated Medication Platform with Video Observation; Other: Time on Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start9 Sep 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Gellman
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Charles Gellman, HiDO Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454514
- Sponsor's protocol ID
- R43MH125483-01A1
- Status last verified
- Mar 2025
- First submitted
- 2 Jul 2022
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results will not be published.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
- ClinicalTrials.gov ID
- NCT05454514
- Acronym / sponsor ID
- R43MH125483-01A1
- Conditions
- HIV Infections
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Charles GellmanIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Automated Medication Platform with Video Observation | Other | Device: HiDO medication adherence platform, Device: Automated Medication Platform with Video Observation, Other: Time on TaskThere is no drug intervention. The device elicits increases adherence of medications. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HiDO medication adherence platformThe 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 |
| Automated Medication Platform with Video ObservationThere is no drug intervention. The device elicits increases adherence of medications. | Device | Automated Medication Platform with Video Observation |
| Time on TaskOther 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. | Other | Automated Medication Platform with Video Observation |
Primary outcome
Rate of Medication Adherence
Time frame: 90 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Results will not be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiDO medication adherence platform, Automated Medication Platform with Video Observation and Time on Task in people with HIV Infections, run by Charles Gellman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Medication Adherence (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.