Care4Today v2.0 Application for Improving Adherence to HIV Medications

HIV Clinical Trial

Official title:

Pilot Study of Care4Today v.2.0 Application for Improving Adherence to HIV Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001064
• Other study ID #: Care4Today-13
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• HIV

Intervention

Behavioral:
• Care4Today v2.0 mobile application + electronic monitoring of adherence
Care4Today mobile application will send automated medication alert messages to HIV-infected 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-infected persons who experience adherence difficulties over standard of care.

Locations

Country	Name	City	State
United States	Hnrc-Tmarc	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants =90% Adherent to Antiretroviral Medication Based on MEMS Cap Openings	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.	Completion of 30-day intervention
Primary	Average Minutes From Antiretroviral Medication Dose Time Based on MEMS Cap Openings	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	Completion of 30-day intervention
Primary	Percentage of Doses Taken in Dose Time Window		Completion of 30-day intervention