Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03205982
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Rebecca Schnall, RN, MPH, PhD, 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Device: Wise app with medication adherence reminders Device: Wise app with fitness reminders Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Wise App Trial for Improving Health Outcomes in People Living With HIV
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Sham Comparator: Control
WiseApp that delivers fitness reminders
Device: Wise app with fitness reminders
The control group will receive the Wise app with fitness reminders

Experimental: Intervention
WiseApp that delivers medication adherence reminders
Device: Wise app with medication adherence reminders
The Intervention group will receive the Wise app that delivers medication adherence reminders.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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, and the maximum total score is 16. Scores of 11 or higher on this index indicate good adherence (Cronbach's α= 0.79).

  2. Change in 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.

  3. 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.

  4. 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.

  5. 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, where the maximum total score is 52.

  6. 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, where the maximum total score is 70.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205982


Locations
Layout table for location information
United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Layout table for investigator information
Principal Investigator: Rebecca Schnall, PhD, RN Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rebecca Schnall, RN, MPH, PhD, Principal Investigator, Columbia University
ClinicalTrials.gov Identifier: NCT03205982    
Other Study ID Numbers: AAAQ9957
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rebecca Schnall, RN, MPH, PhD, Columbia University:
Wisepill
ART
PLWH
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases