The Wise App Trial for Improving Health Outcomes in PLWH (WiseApp)

March 11, 2024 updated by: Rebecca Schnall, RN, MPH, PhD, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
WiseApp that delivers fitness reminders
Behavioral: Wise app with fitness reminders
The control group will receive the Wise app with fitness reminders
Experimental: Intervention
WiseApp that delivers medication adherence reminders
Behavioral: Wise app with medication adherence reminders
The Intervention group will receive the Wise app that delivers medication adherence reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ART Adherence - Clever Cap
Time Frame: Up to 6 months
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 Viral Load
Time Frame: Baseline, 3 month follow up, and 6 month follow up
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
Time Frame: Baseline, 3 months, and 6 months
This will be measured by the self-reported number of primary care visits.
Baseline, 3 months, and 6 months
Change in Score on the Center for Adherence Support Evaluation (CASE) Index
Time Frame: Baseline, 3 month follow up, and 6 month follow up
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, minimum score is 3 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 Cluster of Differentiation 4 (CD4) Count
Time Frame: Baseline, 3 month follow up, and 6 month follow up
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 Score on the Engagement With Health Care Provider Scale
Time Frame: Baseline, 3 months, and 6 months
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. The minimum total score is 13 and 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
Time Frame: Baseline, 3 month follow up and 6 month follow up
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. The minimum total score is 0 and the maximum total score is 70.
Baseline, 3 month follow up and 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Rebecca Schnall, PhD, RN, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

November 24, 2021

Study Completion (Actual)

November 24, 2021

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAQ9957
  • R01HS025071 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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