Trial Outcomes & Findings for Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS (NCT NCT05454514)

NCT ID: NCT05454514

Last Updated: 2025-03-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2025-03-14

Participant Flow

The study successfully recruited 7 patients with HIV/AIDS who met the inclusion criteria, which include age between 18-55, existing prescription for at least one ART, expressed difficulty with medication adherence, access to a personal smartphone and Wi-Fi connection, and the ability to read and write English.To ensure unbiased and rigor results, the inclusion criteria was confirmed by the study team.

Participant milestones

Measure	Automated Medication Platform With Video Observation There is no drug intervention. HiDO medication adherence platform: The device elicits increases adherence of medications. The Primary Endpoint is medication adherence as assessed by remote observation through the HiDO device at 90 days. 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.
Overall Study STARTED	7
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure

Automated Medication Platform With Video Observation There is no drug intervention. HiDO medication adherence platform: The device elicits increases adherence of medications. The Primary Endpoint is medication adherence as assessed by remote observation through the HiDO device at 90 days. 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.

Overall Study Withdrawal by Subject

4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Automated Medication Platform With Video Observation n=3 Participants There is no drug intervention. HiDO medication adherence platform: The device elicits increases adherence of medications.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Automated Medication Platform With Video Observation n=3 Participants There is no drug intervention. HiDO medication adherence platform: The device elicits increases adherence of medications.
Rate of Medication Adherence Percentage of adherence ≥95% adherence	2 Participants
Rate of Medication Adherence Number/Percentage of participants with 80% to 95% adherence.	1 Participants

Adverse Events

Automated Medication Platform With Video Observation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charles Gellman, CEO

HIDO TECHNOLOGIES, INC.

Phone: 5108137224

Email: charles@hidohealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place