The Wise App Trial for Improving Health Outcomes in PLWH

Study Overview
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Brief Summary
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The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.

Detailed Description
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Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral suppression through adherence to antiretroviral (ART) therapy is a critical determinant of successful transmission prevention and long-term outcomes in HIV-infected patients. However only about 25% of persons living with HIV (PLWH) in the US are virally suppressed, demonstrating the need for effective interventions that enhance ART adherence. mHealth is a tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the need for improving medication adherence in PLWH, and the great promise of mHealth, the investigators propose to build and test a user-centered smartphone app linked to a smart pill box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized since it typically overestimated adherence especially in unmasked trials. Current adherence assessments, such as patient recall, pill counts and pharmacy refill data, typically detect missed doses long after they occur. This study will use real-time, wireless monitoring strategies via the Wisepill dispenser, for measuring ART adherence.

Official Title
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The Wise App Trial for Improving Health Outcomes in People Living With HIV

Conditions
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HIV/AIDS

Intervention / Treatment
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* Device: Wise app with medication adherence reminders
* Device: Wise app with fitness reminders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of HIV Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL Be able to communicate and read in English or Spanish Live in the US Have a smartphone Be taking ART medications Exclusion Criteria: Participation in any other mobile app study for PLWH, including text messaging studies Diagnosis of a clinical problem that would preclude someone from using a smartphone

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>WiseApp that delivers fitness reminders | Device: Wise app with fitness reminders<br>* The control group will receive the Wise app with fitness reminders<br>|
| Experimental: Intervention<br>WiseApp that delivers medication adherence reminders | Device: Wise app with medication adherence reminders<br>* The Intervention group will receive the Wise app that delivers medication adherence reminders.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ART Adherence - Clever Cap | The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day). | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score on the Center for Adherence Support Evaluation (CASE) Index | The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings. Items are scored such that higher values indicate better adherence, and the maximum total score is 16. Scores of 11 or higher on this index indicate good adherence (Cronbach's α= 0.79). | Baseline, 3 month follow up, and 6 month follow up | 
| Change in CD4 Count | Using blood samples obtained during study visits, CD4 count will be used to asses ART adherence. | Baseline, 3 month follow up, and 6 month follow up | 
| Change in Viral Load | Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence. | Baseline, 3 month follow up, and 6 month follow up | 
| Change in Number of Primary Care Visits | This will be measured by the self-reported number of primary care visits. | Baseline, 3 months, and 6 months | 
| Change in Score on the Engagement with Health Care Provider Scale | The Engagement with Health Care Provider 13-item Scale will be administered over the course of the trial to evaluate how participants' engagement with their health care providers changes their health care access overall. Items are scored such that higher scores indicate a more negative relationship with their health care provider, where the maximum total score is 52. | Baseline, 3 months, and 6 months | 
| Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire | Technology Acceptance: Perceived Ease of Use and Potential Usefulness 14-item Questionnaire provides a method for assessing participants' perception of the usefulness of the technology. Items are scored such that higher values indicate more positive perception, where the maximum total score is 70. | Baseline, 3 month follow up and 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wisepill, ART, PLWH