Covid19NCT04939532
SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Testing Among Utah Community Health Centers
A study testing Text-Messaging (TM) and Patient Navigation (PN) in people with Covid19, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Text-Messaging (TM) and Patient Navigation (PN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44,729 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Minors
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/ University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Among Utah Community Health Centers
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:
- 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.
- 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).
Read more
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:
- 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.
- Examine implementation effectiveness outcomes, as well as characteristics of both clinics and patients that may influence intervention effects and implementation outcomes.
Read the 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.
- Conditions
- Covid19
- Being tested
- Text-Messaging (TM), Patient Navigation (PN)
- Keywords
- COVID19, Community Health, Health Information Technology, Population Health, Patient engagement, Rural, Scale up, Screening, Testing, Text messaging, Underserved population, Uninsured, Utah, Uptake
- Medical subject headings
- COVID-19, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-Messaging (TM)Behavioural
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.
Patient Navigation (PN)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Text-Messaging (TM) | Active comparator | Population health management intervention that analyzes electronic health record data to automatically identify participants with high risk for either infection or severe disease and proactivity reaches those participants via text message for testing needs (as advised by state and/or federal guidelines) and testing recommendation when applicable. This is a bi-directional text messaging system. Receives: Behavioral: Text-Messaging (TM) |
| Text-Messaging plus Patient Navigation (TM+PN) | Active comparator | Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD testing. Receives: Behavioral: Text-Messaging (TM); Behavioral: Patient Navigation (PN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach-TM Engage
Proportion of patients that respond to the Text Messaging intervention.
Measured: 12 months
Secondary outcomes (4)
Total Patients Tested for COVID as Indicated in Health Record Out of Total Patient Population in Study. (Uptake-Total)
Proportion of patients tested for COVID-19 out of the total patient population. Confirmation of COVID test as indicated in patient's health record.
Measured: 12 months
Reach PN-Engage-Logistics Assistance
Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN
Measured: 12 months
Reach PN-Engage-Requested Navigation
Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN
Measured: 12 months
Uptake-Eligible
Proportion 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start29 Mar 2021
- Primary completion17 Jun 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient-level, two-arm randomized design for the Population Health Management interventions, TM or TM+PN.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Association for Utah Community Health, Utah Department of Health, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, David Wetter, University of Utah
- Investigators
- David Wetter, MS, PhD, Principal investigator, University of UtahRachel Hess, MD, MS, Principal investigator, University of UtahGuilherme Del Fiol, MD, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939532
- Sponsor's protocol ID
- 00136001
- Other IDs
- 3UL1TR002538-03S2
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2021
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Among Utah Community Health Centers
- ClinicalTrials.gov ID
- NCT04939532
- Acronym / sponsor ID
- 00136001
- Conditions
- Covid19
- Keywords
- COVID19, Community Health, Health Information Technology, Population Health, Patient engagement, Rural, Scale up, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44,729 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Association for Utah Community Health, Utah Department of Health, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patient-level, two-arm randomized design for the Population Health Management interventions, TM or TM+PN.
| Arm | Type | Receives |
|---|---|---|
| Text-Messaging (TM) | Active comparator | Behavioral: Text-Messaging (TM)Population health management intervention that analyzes electronic health record data to automatically identify participants with high risk for either infection or severe disease and proactivity reaches those participants via text message for testing needs (as advised by state and/or federal guidelines) and testing recommendation when applicable. This is a bi-directional text messaging system. |
| Text-Messaging plus Patient Navigation (TM+PN) | Active comparator | Behavioral: Text-Messaging (TM), Behavioral: Patient Navigation (PN)Population health management intervention that includes the same bi-directional text-messaging system as Arm 1 (the text messaging condition) with the addition of patient navigation. Patient navigation includes real-time assistance from a community health worker to address barriers, provide motivation, and assist with logistics of COIVD testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Text-Messaging (TM), Text-Messaging plus Patient Navigation (TM+PN) |
| 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. | Behavioural | Text-Messaging plus Patient Navigation (TM+PN) |
Primary outcome
Reach-TM Engage
Time frame: 12 months
Proportion of patients that respond to the Text Messaging intervention.
4 secondary outcomes
Total Patients Tested for COVID as Indicated in Health Record Out of Total Patient Population in Study. (Uptake-Total)
Time frame: 12 months
Reach PN-Engage-Logistics Assistance
Time frame: 12 months
Reach PN-Engage-Requested Navigation
Time frame: 12 months
Uptake-Eligible
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wetter, MS, PhD principal investigator
University of Utah
Rachel Hess, MD, MS principal investigator
University of Utah
Guilherme Del Fiol, MD, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text-Messaging (TM) and Patient Navigation (PN) in people with Covid19, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach-TM Engage (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.