SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres
David W Wetter,
Tom Greene,
Guilherme Del Fiol,
Anna Martinez,
Kensaku Kawamoto,
Jonathan Chipman,
Bryan Gibson,
Leticia Stevens,
Tracey Siaperas,
Chelsey R Schlechter,
Brian Orleans,
Ryan Cornia,
Jennifer Wirth,
Cho Y Lam,
Tatyana V Kuzmenko,
Ray Meads,
Kimberly K Kaphingst,
Andy J King,
Shlisa Hughes,
Alan Pruhs,
Courtney Pariera Dinkins,
Joni H Pierce,
Ryzen Benson,
Emerson P Borsato,
Richard L Bradshaw
Affiliations
David W Wetter
Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA
Tom Greene
Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA
Guilherme Del Fiol
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Anna Martinez
6Hospital de la Ribera, Rheumatology, Alzira, Spain
Kensaku Kawamoto
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Jonathan Chipman
Department of Population Health Sciences, University of Utah, Salt Lake City, Utah, USA
Bryan Gibson
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Leticia Stevens
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Tracey Siaperas
Association for Utah Community Health, Salt Lake City, Utah, USA
Chelsey R Schlechter
Center for Health Outcomes and Population Equity, University of Utah Health Huntsman Cancer Institute, Salt Lake City, Utah, USA
Brian Orleans
Center for Health Outcomes and Population Equity, University of Utah Health Huntsman Cancer Institute, Salt Lake City, Utah, USA
Ryan Cornia
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Jennifer Wirth
Center for Health Outcomes and Population Equity, University of Utah Health Huntsman Cancer Institute, Salt Lake City, Utah, USA
Cho Y Lam
Center for Health Outcomes and Population Equity, University of Utah Health Huntsman Cancer Institute, Salt Lake City, Utah, USA
Tatyana V Kuzmenko
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Ray Meads
Center for Health Outcomes and Population Equity, University of Utah Health Huntsman Cancer Institute, Salt Lake City, Utah, USA
Kimberly K Kaphingst
Department of Communication, University of Utah, Salt Lake City, Utah, USA
Andy J King
Department of Communication, University of Utah, Salt Lake City, Utah, USA
Shlisa Hughes
Association for Utah Community Health, Salt Lake City, Utah, USA
Alan Pruhs
Association for Utah Community Health, Salt Lake City, Utah, USA
Courtney Pariera Dinkins
Association for Utah Community Health, Salt Lake City, Utah, USA
Joni H Pierce
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Ryzen Benson
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Emerson P Borsato
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Richard L Bradshaw
Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA
Introduction SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).Methods and analysis The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.Ethics and dissemination The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.Trial registration number ClinicalTrials.gov: NCT05533918 and NCT05533359.