Clinical trial NCT03205982: The Wise App Trial for Improving Health Outcomes in PLWH
Official title: The Wise App Trial for Improving Health Outcomes in People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Wisepill
ART
PLWH
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2017-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in ART Adherence - Clever Cap
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in Score on the Center for Adherence Support Evaluation (CASE) Index
timeFrame: Baseline, 3 month follow up, and 6 month follow up
measure: Change in Cluster of Differentiation 4 (CD4) Count
timeFrame: Baseline, 3 month follow up, and 6 month follow up
measure: Change in Viral Load
timeFrame: Baseline, 3 month follow up, and 6 month follow up
measure: Change in Number of Primary Care Visits
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Score on the Engagement With Health Care Provider Scale
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire
timeFrame: Baseline, 3 month follow up and 6 month follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flynn G, Jia H, Reynolds NR, Mohr DC, Schnall R. Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). BMC Public Health. 2020 Nov 25;20(1):1775. doi: 10.1186/s12889-020-09688-0.
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.