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Care4Today v2.0 Application for Improving Adherence to HIV Medications

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ClinicalTrials.gov Identifier: NCT02001064
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : November 3, 2014
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
David J. Moore, Ph.D., University of California, San Diego

Study Description
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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+ 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.


Condition or disease Intervention/treatment Phase
HIV AIDS Behavioral: Application + Standard of care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence to Antiretroviral Medication [ Time Frame: Completion of 30-day intervention ]
    Adherence will be measured using Medication Event Monitoring Systems (MEMS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001064


Locations
United States, California
Hnrc-Tmarc
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Janssen Research & Development, LLC
Investigators
Principal Investigator: David J. Moore, Ph.D. University of California, San Diego
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: David J. Moore, Ph.D., Associate Professor of Psychiatry, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02001064     History of Changes
Other Study ID Numbers: Care4Today-13
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by David J. Moore, Ph.D., University of California, San Diego:
interventions
technology
adherence
ARV