Care4Today v2.0 Application for Improving Adherence to HIV Medications
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+ participants.
The pilot RCT consists of 60 HIV+ persons who are at risk for ART medication nonadherence. Using random assignment, 30 HIV+ participants will be assigned to medication adherence improvement via "Care4Today" app as compared to 30 HIV+ 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+ persons assigned to the Care4Today intervention and 30 HIV+ persons assigned to standard of care.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications|
- Adherence to Antiretroviral Medication [ Time Frame: Completion of 30-day intervention ] [ Designated as safety issue: No ]Adherence will be measured using Medication Event Monitoring Systems (MEMS)
|Study Start Date:||October 2013|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Application + Standard of care
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.
Behavioral: Application + Standard of care
Care4Today mobile application will send automated medication alert messages to HIV+ 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+ persons who experience adherence difficulties over standard of care.
No Intervention: Standard of care
Participants will receive standard of care while on study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02001064
|United States, California|
|San Diego, California, United States, 92103|
|Principal Investigator:||David J. Moore, Ph.D.||University of California, San Diego|