The Wise App Trial for Improving Health Outcomes in PLWH

HIV/AIDS Clinical Trial

— WiseApp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205982
• Other study ID #: AAAQ9957
• Secondary ID: R01HS025071
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: November 24, 2021

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Wise app with medication adherence reminders
The Intervention group will receive the Wise app that delivers medication adherence reminders.
• Wise app with fitness reminders
The control group will receive the Wise app with fitness reminders

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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, minimum score is 3 and the maximum total score is 16. Scores of 11 or higher on this index indicate good adherence (Cronbach's a= 0.79).	Baseline, 3 month follow up, and 6 month follow up
Secondary	Change in Cluster of Differentiation 4 (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
Secondary	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
Secondary	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
Secondary	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. The minimum total score is 13 and the maximum total score is 52.	Baseline, 3 months, and 6 months
Secondary	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. The minimum total score is 0 and the maximum total score is 70.	Baseline, 3 month follow up and 6 month follow up