Care4Today v2.0 Application for Improving Adherence to HIV Medications

University of California San Diego

Status: Completed

Conditions: AIDS; HIV

Treatments: Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02001064

Care4Today-13

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Care4Today v2.0 mobile application + electronic monitoring of adherence

Experimental group

Description:

Care4Today v2.0 mobile application 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. Electronic monitoring of adherence: Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap.

Treatment:

Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence

Electronic monitoring of adherence

No Intervention group

Description:

Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap.