CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Care4Today v2.0 mobile application + electronic monitoring of adherencebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02001064
NCT02001064N/ACompleted

Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications

University of California, San Diego·interventional·Posted Dec 4, 2013·Updated Jul 29, 2021

In Brief

A clinical study evaluating Care4Today v2.0 mobile application + electronic monitoring of adherence for HIV and AIDS. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, AIDS
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 4, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.6 years ago

Interventions

Care4Today v2.0 mobile application + electronic monitoring of adherencebehavioral

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.