Mobile Health Application to Improve HIV Medication Adherence

Study Overview
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Brief Summary
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Inadequate adherence to antiretroviral therapy (ART) can impede successful viral suppression and consequently lead to negative health consequences. This study aims to refine and test the efficacy of a mobile health ART adherence application (ARTAA), delivered over a smartphone, with helping individuals improve their ART adherence.

Detailed Description
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The CDC estimates that 1.1 million people living in the U.S. are infected with HIV [1]. Only a quarter of person living with HIV (PLWH) successfully keep the virus under control [2]. Medication non-adherence is a significant contributor to unsuccessful viral suppression; a recent meta-analysis found that only an estimated 59% of participants in North American studies were adherent at a commonly accepted minimal threshold for successful viral suppression [3]. While newer antiretroviral therapy (ART) medications can produce viral suppression at lower levels of adherence, relatively high adherence is still necessary to avoid disease progression and shortened lifespan [4-6]. In addition, low levels of adherence increase the risk of infecting others and contribute to the development of treatment resistant strains of HIV [7;8]. Interventions have been developed to address the significant public health problem presented by poor adherence, with most studies demonstrating some degree of success in the short-term [9]. However, the impact of the interventions is generally not sustained over time [9], and most HIV treatment settings do not have the resources to deliver more intensive interventions. As a result, there has been interest in developing efficacious electronically-delivered interventions. Very little research has focused on establishing the efficacy of mobile health applications for ART adherence. Further, no published studies have examined a single session face-to-face intervention combined with a mobile application and coaching support to reinforce sustained adherence. Delivered over a smartphone, portable applications would allow for real-time adherence tracking and feedback and ready access to content or services to enhance adherence. The long-term goal of this line of research is to disseminate an efficacious, mobile health ART adherence application that can be integrated readily into clinical care. The objective of this application is to develop a mobile health ART adherence application, to pilot the application, and to conduct a preliminary randomized controlled trial of the application.

Official Title
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Mobile Health Application to Improve HIV Medication Adherence

Conditions
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HIV, Medication Adherence, Mobile Health

Intervention / Treatment
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* Behavioral: Twine Collaborative Care Application
* Behavioral: Information-Motivation-Behavioral Skills Model of ART Adherence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prescribed ART, infected with HIV, have a detectable viral load (>20 copies/mL) with the past 6 months, report less than 100% medication adherence, and have a smart phone capable of downloading the mARTAA application. Exclusion Criteria: Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension, active psychosis, and not fluent in English.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health ART Adherence Application (mARTAA)<br>mARTAA will use a smartphone-delivered application developed by Twine Health, Inc. | Behavioral: Twine Collaborative Care Application<br>* This application features a 24-hour medication clock that displays ART dosing schedule and allows participants to record the doses taken. It also features an interactive health coaching feature which will be used to provide support, encouragement, and resources to participants.<br>|
| Active Comparator: Face-to-Face ART Adherence Intervention<br>A single face-to-face ART adherence intervention will be administered. | Behavioral: Information-Motivation-Behavioral Skills Model of ART Adherence<br>* Combines brief motivational interviewing, cognitive behavior therapy, and problem-solving skills to help participants formulate and follow ART adherence goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ART Adherence | Percentage of ART adherence based on Electronic Pill Box data will be compared between the groups | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported ART Adherence | Self-reported ART adherence as measured by the AACTG Medication Adherence Questionnaire will be compared between the groups. | 12 Months | 
| Viral Load | Viral load will be dichotomized into three levels (20, 48, and 400 copies/ML) and intervention effects will be examined at each of these levels. | 12 Months | 
| Behavioral Skills | Group differences will be examined in behavioral skills as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. | 12 Months | 
| Information | Group differences will be examined in information as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. | 12 Months | 
| Information, Motivation, and Behavioral Skills | Group differences will be examined in motivation as assessed by the LifeWindows Information-Motivation-Behavioral Skills ART Adherence Questionnaire. | 12 Months | 
| Self-Efficacy | Group differences will be examined in self-efficacy as assessed by the HIV Treatment Adherence Self-Efficacy Questionnaire | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Medication Adherence, Mobile Health