N/A N=60 Randomized Health Services Research

Care4Today v2.0 Application for Improving Adherence to HIV Medications

HIV · AIDS

Bottom Line

View on ClinicalTrials.gov: NCT02001064 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings — 9; 5 Participants — p=0.32

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Care4Today v2.0 mobile application + electronic monitoring of adherence (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings	9; 5	0.32
PRIMARY Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings	112.0; 146.7	0.073
PRIMARY Percentage of Doses Taken in Dose Time Window	66.8; 57.5	0.24

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02001064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.