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NCT Number: NCT03205982

The Wise App Trial for Improving Health Outcomes in PLWH

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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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wise app with medication adherence reminders

Behavioral

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

Wise app with fitness reminders

Behavioral

The control group will receive the Wise app with fitness reminders

Primary outcomes

  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 outcomes

  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, 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).

  2. 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

  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. The minimum total score is 13 and 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. The minimum total score is 0 and the maximum total score is 70.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: WiseApp

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2017
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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