Care4Today v2.0 Application for Improving Adherence to HIV Medications

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV, AIDS

Intervention / Treatment
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* Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care4Today v2.0 mobile application + electronic monitoring of adherence<br>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. | Behavioral: Care4Today v2.0 mobile application + electronic monitoring of adherence<br>* 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.<br>|
| No Intervention: Electronic monitoring of adherence<br>Participants' adherence to antiretroviral therapy medication is measured via Medication Event Monitoring System (MEMS) cap. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Percentage of Doses Taken in Dose Time Window |  | Completion of 30-day intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARV, interventions, technology, adherence