AIDS, HIV
Conditions
Keywords
interventions, technology, adherence, ARV
Brief summary
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.
Interventions
BEHAVIORALCare4Today v2.0 mobile application + electronic monitoring of adherence
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.
Sponsors
Janssen Research & Development, LLC
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide informed consent * 18 years or older at the time of enrollment * HIV-infected * Taking at least one medication to treat HIV illness * Indication of medication nonadherence, or having a condition (e.g., active substance use, depression) that puts the individual at risk for medication non adherence * Willingness to use electronic monitoring caps to track ART medication * Willingness to respond to application alert messages
Exclusion criteria
* Axis I psychiatric diagnosis of psychotic disorder or mood disorder with psychotic features * Presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Huntington's Disease, Stroke) * Unwillingness or inability to use electronic medication monitoring technology * Unwillingness or inability to use daily alert messages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings | Completion of 30-day intervention | 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. |
| Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings | Completion of 30-day intervention | 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 |
| Percentage of Doses Taken in Dose Time Window | Completion of 30-day intervention | — |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Electronic Monitoring of Adherence Electronic monitoring of adherence:
Participants' adherence to antiretroviral therapy medication is measured via MEMS cap. | 29 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Electronic Monitoring of Adherence | Total |
|---|---|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 9.6 | 48.5 years STANDARD_DEVIATION 9.5 | 49.2 years STANDARD_DEVIATION 9.4 |
| Education | 13.9 years STANDARD_DEVIATION 2.2 | 12.9 years STANDARD_DEVIATION 2.9 | 13.4 years STANDARD_DEVIATION 2.6 |
| Race/Ethnicity, Customized Hispanic | 1 participants | 5 participants | 6 participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 12 participants | 8 participants | 20 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 14 participants | 15 participants | 29 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 28 participants | 29 participants | 57 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings | 112.0 minutes from target dose time | Standard Deviation 112 |
| Electronic Monitoring of Adherence | Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings | 146.7 minutes from target dose time | Standard Deviation 101 |
p-value: 0.073Wilcoxon (Mann-Whitney)
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings | 9 Participants |
| Electronic Monitoring of Adherence | Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings | 5 Participants |
p-value: 0.32t-test, 1 sided
Primary
Percentage of Doses Taken in Dose Time Window
Time frame: Completion of 30-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Care4Today v2.0 Mobile Application + Electronic Monitoring of Adherence | Percentage of Doses Taken in Dose Time Window | 66.8 Percentage of doses taken in window | Standard Deviation 27 |
| Electronic Monitoring of Adherence | Percentage of Doses Taken in Dose Time Window | 57.5 Percentage of doses taken in window | Standard Deviation 32.2 |
p-value: 0.24Wilcoxon (Mann-Whitney)