Care4Today v2.0 Application for Improving Adherence to HIV Medications

Not Applicable

Completed

• Conditions: HIV; AIDS
• Interventions: Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence

• Registration Number: NCT02001064
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-04
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2021-06-03
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Results First Posted: 2021-07-29
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care4Today v2.0 mobile application + electronic monitoring of adherence	Care4Today v2.0 mobile application + electronic monitoring of adherence	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.

Primary Outcome Measures

Name	Time	Method
Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings	Completion of 30-day intervention	The absolute value (in minutes) from the time a participant was scheduled to take an antiretroviral medication dose to when the participant opened the MEMS cap
Number of Participants ≥90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings	Completion of 30-day intervention	Adherence will be measured using Medication Event Monitoring Systems (MEMS). Adherence defined as % MEMS adherence (doses taken/doses prescribed) within 2 hours of the indicated dose time. Adherence was dichotomized into 2 groups: \<90% and ≥90% using MEMS caps.
Percentage of Doses Taken in Dose Time Window	Completion of 30-day intervention

Trial Locations

Locations (1)

Hnrc-Tmarc; 🇺🇸 San Diego, California, United States