The Wise App Trial for Improving Health Outcomes in PLWH

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: Wise app with fitness reminders; Behavioral: Wise app with medication adherence reminders

• Registration Number: NCT03205982
• Lead Sponsor: Columbia University

Brief 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.

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 Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2018-01-31
• Primary Completion: 2021-11-24
• Study Completion: 2021-11-24
• Results First Submitted: 2022-08-09
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Results First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Wise app with fitness reminders	WiseApp that delivers fitness reminders
Intervention	Wise app with medication adherence reminders	WiseApp that delivers medication adherence reminders

Primary Outcome Measures

Name	Time	Method
Change in ART Adherence - Clever Cap	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).

Secondary Outcome Measures

Name	Time	Method
Change in Number of Primary Care Visits	Baseline, 3 months, and 6 months	This will be measured by the self-reported number of primary care visits.
Change in Cluster of Differentiation 4 (CD4) Count	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
Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire	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.
Change in Score on the Center for Adherence Support Evaluation (CASE) Index	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).
Change in Viral Load	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.
Change in Score on the Engagement With Health Care Provider Scale	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States