Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04939532
Enrollment
44729
Registered
2021-06-25
Start date
2021-03-29
Completion date
2023-02-28
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID19, Community Health, Health Information Technology, Population Health, Patient engagement, Rural, Scale up, Screening, Testing, Text messaging, Underserved population, Uninsured, Utah, Uptake

Brief 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.

Detailed description

SCALE-UP Utah is a patient-level intervention involving 12 Community Health Centers (39 individual clinics) across Utah. The study is designed to utilize Community Health Center participant records to proactively reach participants for COVID-19 screening and testing. This intervention includes a randomization component between two interventions, text messaging (TM) or text messaging with patient navigation (TM+PN). These two intervention paths are occurring simultaneously within the same clinics. Text messaging (TM) and text messaging with patient navigation (TM+PN) Overview: Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen for if the participant or someone in their close social network should get tested. Participants who reply "yes" will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and an option for an at-home test to be sent directly to their home. Participants who reply "no" will receive a text with the clinic phone number and a note to call if anything changes. Participants in the TM+PN condition will receive the same text messages as the patients in the TM condition. Text messages will include a brief message regarding risk and will screen for if the patient should get tested. Patients who reply "yes" will receive the same options as those in TM only (a recommendation to be tested, testing locations/hours/phone, and an option for an at-home test to be sent directly to their home) in addition to a notice that a Community Health Worker will contact them for patient navigation. The Patient Navigation includes practical advice from navigators to address barriers to testing such as logistics, transportation, and expenses. Step One: Primary Data Extraction To identify the cohort for the TM and TM+PN interventions, a subset of EHR data will be manually extracted from the Community Health Centers as text files generated by EHR reports. The first set of EHR reports will contain all patients seen at each of the Community Health Centers in the last 3 years. Subsequent reports will be obtained weekly, including all encounters in the previous week. Data fields will include risk factors such as age, gender, body mass index, encounter diagnoses for medical co-morbidities, participant demographics (e.g., zip code, insurance status, preferred language, race/ethnicity); as well as cellphone number for text messaging and patient navigation. Step Two: Randomization & Cohort Selection Once the data are securely housed, all participants will be assigned to either the TM or TM+PN arm of the intervention. This assignment will remain consistent throughout the study. Cohort selection will be based on EHR data considering factors such as age, race/ethnicity, language, relevant medical comorbidities, and residence in hotspot areas. These selection criteria are consistent with recommendations from Utah Department of Health and the Centers for Disease Control and Prevention. Step Three: Implementation SCALE-UP Utah will send HIPPA-compliant bidirectional texts, which is a communication method routinely used by the Community Health Centers, to patients in high risk cohorts. Text messages will be designed by the research team and sent using a HIPPA compliant text messaging service. The text messaging service will retrieve the participant cohort from the study database to send the texts to the participants. The text messages will appear to the participants as having originated from their Community Health Center. As part of their general Community Health Center care, participants have agreed to be contacted by their Community Health Center and text message communication is one of those established contact methods. Text messages will be repeated weekly, as needed, to continuously screen for COVID-19 testing eligibility and to provide updates. Every text message will include the option to reply STOP to opt-out of receiving text messages at any time. The text messaging and patient navigation arms of the study will proactively provide patients with access to informative resources describing what would happen if they test positive and where to seek help.

Interventions

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.

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

University of Utah
Lead SponsorOTHER
Association for Utah Community Health
CollaboratorOTHER
Utah Department of Health
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Masking description

Patients will not know if they are in the TM or TM+PN intervention arm.

Intervention model description

Patient-level, two-arm randomized design for the Population Health Management interventions, TM or TM+PN.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Minors

Design outcomes

Primary

MeasureTime frameDescription
Reach-TM Engage12 monthsProportion of patients that respond to the Text Messaging intervention.

Secondary

MeasureTime frameDescription
Total Patients Tested for COVID as Indicated in Health Record Out of Total Patient Population in Study. (Uptake-Total)12 monthsProportion of patients tested for COVID-19 out of the total patient population. Confirmation of COVID test as indicated in patient's health record.
Reach PN-Engage-Logistics Assistance12 monthsProportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN
Reach PN-Engage-Requested Navigation12 monthsProportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN
Uptake-Eligible12 monthsProportion of patients tested for COVID-19 out of those who meet screening criteria for testing. For each patient, we will define a separate Uptake-Eligible measurement for each week of the intervention period in which the patient either responds to a text message or contacts his/her Community Health Center to indicate the presence of symptoms or contact with someone with COVID-19 during the current week, but did not do so in the preceding week.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid Wetter, MS, PhD

University of Utah

PRINCIPAL_INVESTIGATORRachel Hess, MD, MS

University of Utah

PRINCIPAL_INVESTIGATORGuilherme Del Fiol, MD, PhD

University of Utah

Baseline characteristics

Characteristic
Age, Customized
18-29 years old
13948 Participants
Age, Customized
30-64 years old
27067 Participants
Age, Customized
65 and older
3714 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10792 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9198 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2251 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native White
677 Participants
Race/Ethnicity, Customized
Asian
396 Participants
Race/Ethnicity, Customized
Black or African American
581 Participants
Race/Ethnicity, Customized
More than one race
839 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
385 Participants
Race/Ethnicity, Customized
Other Race
6071 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
3723 Participants
Race/Ethnicity, Customized
White
28271 Participants
Sex/Gender, Customized
Female
24430 Participants
Sex/Gender, Customized
Male
8925 Participants
Sex/Gender, Customized
Other or unknown
2154 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 22,1450 / 22,584
other
Total, other adverse events
0 / 22,1450 / 22,584
serious
Total, serious adverse events
0 / 22,1450 / 22,584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026