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N/A N=65,300 Randomized Single-blind Screening

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

Covid19

Enrolled (actual)
65,300
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Uptake-Total — 14308; 14381 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Text-Messaging (TM) (Behavioral); Patient Navigation (PN) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Utah
Primary completion
Jun 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Uptake-Total
14308; 14381
SECONDARY
Reach-TM Engage
5538; 5587
SECONDARY
Reach-PN Engage- Logistics Assistance
0; 592
SECONDARY
Reach-PN Engage- Requested Navigation
0; 122

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, and uptake of COVID-19 vaccines among Utah's Community Health Center patient population. The study will compare two practical, feasible, scalable interventions to increase COVID-19 vaccine uptake in Utah Community Health Centers: 1. Text Messaging (TM): population health management (PHM) intervention that analyzes EHR data to automatically identify patients eligible for COVID-19 vaccination and uses bi-directional text messaging to help connect patients to a vaccination site; 2. Patient Navigation (PN): PHM intervention to increase vaccination 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 vaccinations among CHC patients across Utah. Our primary outcome, Uptake-Eligible, is defined as the proportion of patients who receive a COVID-19 vaccination out of those who meet eligibility criteria for vaccination. 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.

Eligibility Criteria

Inclusion Criteria

  • current patient of a participating community health center
  • have a working cellphone,
  • have phone number listed in existing electronic medical record at their participating clinic
  • speak English or Spanish.

Exclusion Criteria

  • Minors
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04939519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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