Care4Today v2.0 Application for Improving Adherence to HIV Medications
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | October 2013 |
| End Date: | August 2014 |
| Contact: | Jennifer Marquie-Beck, M.P.H. |
| Email: | jmarquie@ucsd.edu |
| Phone: | 619-543-5000 |
Pilot Study of Care4Today v.2.0 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.
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.
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
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