Trial Outcomes & Findings for Care4Today v2.0 Application for Improving Adherence to HIV Medications (NCT NCT02001064)
NCT ID: NCT02001064
Last Updated: 2021-07-29
Results Overview
Adherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: \<90% and ≥90% using MEMS caps.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Completion of 30-day intervention
Results posted on
2021-07-29
Participant Flow
We enrolled 60 participants for the study cohort. 58 participants completed the initial assessment, 2 decided to discontinue after randomization (both did not wish to use the mobile application and phone for the duration of the study). Additionally, 1 participant decided to no longer participate in research studies between visits one and two.
Participant milestones
| Measure |
Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence
Care4Today v2.0 mobile application
Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
Electronic Monitoring of Adherence
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence
Care4Today v2.0 mobile application
Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
Electronic Monitoring of Adherence
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Care4Today v2.0 Application for Improving Adherence to HIV Medications
Baseline characteristics by cohort
| Measure |
Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence
n=28 Participants
Care4Today v2.0 mobile application
Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
Electronic Monitoring of Adherence
n=29 Participants
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
48.5 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
49.2 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
12 participants
n=99 Participants
|
8 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
29 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Education
|
13.9 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
12.9 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
13.4 years
STANDARD_DEVIATION 2.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: Completion of 30-day interventionAdherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: \<90% and ≥90% using MEMS caps.
Outcome measures
| Measure |
Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence
n=28 Participants
Care4Today v2.0 mobile application
Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
Electronic Monitoring of Adherence
n=29 Participants
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
|---|---|---|
|
Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings
|
9 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Completion of 30-day interventionThe absolute value (in minutes) from the time a participant was scheduled to take an antiretroviral medication dose to when the participant opened the MEMS cap
Outcome measures
| Measure |
Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence
n=28 Participants
Care4Today v2.0 mobile application
Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
Electronic Monitoring of Adherence
n=29 Participants
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
|---|---|---|
|
Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
|
112.0 minutes from target dose time
Standard Deviation 112.0
|
146.7 minutes from target dose time
Standard Deviation 101.0
|
PRIMARY outcome
Timeframe: Completion of 30-day interventionOutcome measures
| Measure |
Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence
n=28 Participants
Care4Today v2.0 mobile application
Participants in the experimental application arm will use the Care4Today v2.0 mobile application for antiretroviral medication adherence support. Alert messages generated via the app will be targeted to the specific schedule and needs of the individual.
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
Electronic Monitoring of Adherence
n=29 Participants
Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap.
|
|---|---|---|
|
Percentage of Doses Taken in Dose Time Window
|
66.8 Percentage of doses taken in window
Standard Deviation 27.0
|
57.5 Percentage of doses taken in window
Standard Deviation 32.2
|
Adverse Events
Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Electronic Monitoring of Adherence
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
Dr. David J Moore, Professor of Psychiatry
UCSD HIV Neurobehavioral Research Program (HNRP)
Phone: 619-543-5093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place