Clinical trial NCT02001064: Care4Today v2.0 Application for Improving Adherence to HIV Medications
Official title: Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Keywords: interventions
technology
adherence
ARV
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Janssen Research & Development, LLC
First posted: 2013-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings
timeFrame: Completion of 30-day intervention
measure: Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings
timeFrame: Completion of 30-day intervention
measure: Percentage of Doses Taken in Dose Time Window
timeFrame: Completion of 30-day intervention
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Hnrc-Tmarc
state: California
Study officials:
affiliation: University of California, San Diego
name: David J. Moore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: