The Wise App Trial for Improving Health Outcomes in PLWH

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2021-11-24

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.

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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.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

WiseApp that delivers fitness reminders

Group Type SHAM_COMPARATOR

Wise app with fitness reminders

Intervention Type BEHAVIORAL

The control group will receive the Wise app with fitness reminders

Intervention

WiseApp that delivers medication adherence reminders

Group Type EXPERIMENTAL

Wise app with medication adherence reminders

Intervention Type BEHAVIORAL

The Intervention group will receive the Wise app that delivers medication adherence reminders.

Interventions

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Wise app with medication adherence reminders

The Intervention group will receive the Wise app that delivers medication adherence reminders.

Intervention Type BEHAVIORAL

Wise app with fitness reminders

The control group will receive the Wise app with fitness reminders

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No