SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Testing Among Utah Community Health Centers

NCT04939532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44729

Last updated 2026-02-04

Study results available
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Summary

SCALE-UP Utah is a community-academic partnership to address COVID-19 among Utah community health centers. The long-term objective of the project is to increase the reach, acceptance, uptake, and long-term sustainability of COVID-19 screening and testing among Utah's Community Health Center patient population. The study will compare two practical, feasible, scalable interventions to increase COVID-19 testing uptake in Utah Community Health Centers:

1. Text Messaging (TM): population health management (PHM) intervention that analyzes EHR data to automatically identify patients with high risk for either infection or severe disease, reaches and screens those patients, and addresses testing logistics using bi-directional text messaging.
2. Patient Navigation (PN): PHM intervention to increase testing uptake among eligible patients (identified via TM) using patient navigation (e.g., motivating patients, addressing logistics and barriers).

The project will employ a rapid cycle research approach in which interventions are tested on a small scale, using short time frames (e.g., \<1 month) and cyclical evaluation cycles. This process involves implementing intervention messages with a small number of clinics or patients, evaluating the outcomes, and either adapting the intervention messages based on findings (and retesting) or disseminating effective approaches to additional clinics or patients. A critical feature of these cycles is the ability to quickly test and refine messages in a limited setting before broader implementation. Throughout the study, intervention messages were updated or adapted in response to evolving public health guidelines, testing procedures, and policy recommendations (e.g., priority populations by age group or geographic area, as advised by the Utah Department of Health and Human Services and relevant federal agencies). However, these updates did not alter the fundamental structure of the intervention arms. Participants were randomized to one of two main conditions-Text Messaging (TM) or Text Messaging plus Patient Navigation (TM+PN)-and all participants within a given arm received interventions aligned with their assigned condition. Adaptations occurred within the content and timing of messages or navigation support, but the core components of the interventions remained consistent across participants within each arm. These adaptations were tracked and incorporated into implementation logs but did not constitute distinct intervention arms or conditions.

The specific aims are to:

1. Implement and evaluate PHM interventions for increasing the uptake of COVID-19 testing among CHC patients across Utah. Our primary outcome, Uptake-Eligible, is defined as the proportion of patients who are tested for COVID-19 out of the patients who meet screening criteria for COVID-19 testing. Our study hypothesis is that patients in the TM+PN cohort will have higher rates of uptake-eligible than those in the TM cohort.
2. Examine implementation effectiveness outcomes, as well as characteristics of both clinics and patients that may influence intervention effects and implementation outcomes.

Conditions

  • Covid19

Interventions

BEHAVIORAL

Text-Messaging (TM)

Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID testing needs. Participants who reply "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. Patients who reply "no" will receive a text with the clinic phone number and a note to call if anything changes.

BEHAVIORAL

Patient Navigation (PN)

Patients in the PN condition, who respond "yes" to accepting testing will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an offer to receive a free at-home test mailed to their home. In addition they will receive a notice via text message that a Community Health Worker will contact them for patient navigation. At this time, patients will will have the option to opt-out of the phone call from the patient navigator. The Patient Navigation includes advice from navigators to address practical barriers to COVID testing such as logistics, transportation, and expenses as well as behavioral barriers such as hesitancy, fear, and uncertainty.

Sponsors & Collaborators

  • Association for Utah Community Health

    collaborator OTHER
  • Utah Department of Health

    collaborator OTHER
  • National Institutes of Health (NIH)

    collaborator NIH
  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH
  • University of Utah

    lead OTHER

Principal Investigators

  • David Wetter, MS, PhD · University of Utah

  • Rachel Hess, MD, MS · University of Utah

  • Guilherme Del Fiol, MD, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2022-06-17
Completion
2023-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939532 on ClinicalTrials.gov