An interventional study of Care4Today v2.0 mobile application + electronic monitoring of adherence in HIV and AIDS, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-29.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Health services research
Although poor antiretroviral (ART) adherence in HIV does not mean a complete lack of therapeutic results, the benefit of ART increases as adherence improves. Consequences of suboptimal ART adherence are viral rebound, development of drug-resistant HIV strains, and more rapid progression to AIDS. Moreover, HIV-infected persons tend to have numerous co-occurring conditions and therefore take many medications making adherence to multiple drug regimens more difficult. A mobile application capable of improving medication adherence among HIV-infected persons would be highly useful.
The investigators propose an intervention study designed to address these potential mechanisms of nonadherence by utilizing the Care4Today v2.0 smartphone application (app). The current study is a small pilot Randomized Controlled Trial (RCT) comparing the smart phone application titled "Care4Today v2.0" versus standard of care to improve medication adherence to ART over a 4-week period with 60 HIV-infected participants.
The pilot RCT consists of 60 HIV-infected persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV-infected participants will be assigned to medication adherence improvement via "Care4Today" app as compared to 30 HIV-infected participants assigned standard of care.
The investigators will assess the effectiveness and acceptability of the app in improving objectively measured ART adherence (i.e., via medication event monitoring system caps) over a 4-week period via a pilot RCT with 30 HIV-infected persons assigned to the Care4Today intervention and 30 HIV-infected persons assigned to standard of care.
University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
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 Medication Event Monitoring System (MEMS) cap.
Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence
Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap.
Care4Today mobile application will send automated medication alert messages to HIV-infected persons. The alert messages are customizable and automated, and real-time results are viewable within the application. The Care4Today intervention is designed to improve adherence to ART medications among HIV-infected persons who experience adherence difficulties over standard of care.
Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings
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.
Time frame: Completion of 30-day intervention
Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
The 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
Time frame: Completion of 30-day intervention
Percentage of Doses Taken in Dose Time Window
Time frame: Completion of 30-day intervention
| Milestone | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence |
|---|---|---|
| Started | 30 | 30 |
| Completed | 28 | 29 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
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.
| Participants | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence |
|---|---|---|
| Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings | 9 | 5 |
The 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
| minutes from target dose time | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence |
|---|---|---|
| Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings | 112.0 ± 112.0 | 146.7 ± 101.0 |
| Percentage of doses taken in window | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence |
|---|---|---|
| Percentage of Doses Taken in Dose Time Window | 66.8 ± 27.0 | 57.5 ± 32.2 |
Collected over Adverse event data were collected while participants were on study (i.e., 30 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Electronic Monitoring of Adherence | 0/29 (0%) | 0/29 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence | Total |
|---|---|---|---|
| Mean | 49.8 ± 9.6 | 48.5 ± 9.5 | 49.2 ± 9.4 |
| Sex: Female, Male(Participants) | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 24 | 27 | 51 |
| Race/Ethnicity, Customized(participants) | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence | Total |
|---|---|---|---|
| Non-Hispanic White | 14 | 15 | 29 |
| Non-Hispanic Black | 12 | 8 | 20 |
| Hispanic | 1 | 5 | 6 |
| Other | 1 | 1 | 2 |
| Region of Enrollment(participants) | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence | Total |
|---|---|---|---|
| United States | 28 | 29 | 57 |
| Education(years) | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence | Total |
|---|---|---|---|
| Mean | 13.9 ± 2.2 | 12.9 ± 2.9 | 13.4 ± 2.6 |
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University of California, San Diego