Covid19NCT04939519
SCALE-UP Utah: Community-Academic Partnership to Address COVID-19 Vaccination Rates 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, and uptake of COVID-19 vaccines 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
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65,300 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
- have a working cellphone,
- have phone number listed in existing electronic medical record at their 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, 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:
- 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;
- 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).
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 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.
- 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 patient records to proactively reach patients for COVID-19 vaccinations. 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. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Participants in the TM+PN condition will receive the same text message as the participants in the TM condition. Texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive the same information about how and where to receive a vaccine however, they will also receive a message alerting them that a Community Health Worker will contact them to assist with this process, in case they need that. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
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, patient 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 patients will be assigned to either the TM or TM+PN arm of the intervention. This assignment will remain consistent throughout the study. Cohort selection for the text messages will be based on EHR data considering factors such as age, race/ethnicity, language, relevant medical comorbidities, and residence in low-vaccination 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 who are eligible for COVID-19 vaccination. 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 patient cohort from the study database to send the texts to the patients. The text messages will appear to the patients as having originated from their Community Health Center. As part of their general Community Health Center care, patients 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 bi-weekly to continuously prompt vaccination update. This process will repeat until the participant indicates that they have either scheduled or received their vaccination. Every text message will include the option to reply STOP to opt-out of receiving text messages at any time.
- 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, vaccinations, Text messaging, Underserved population, Uninsured, Utah, Uptake, Population Health Tool
- 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
Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Patient Navigation (PN)Behavioural
Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
| 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 who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system. Receives: Behavioral: Text-Messaging (TM) |
| Text-Messaging plus Patient Navigation | 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 vaccination. 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.
Uptake-Total
Proportion of patients who receive a COVID-19 vaccine out of the total patient population
Measured: 12 months
Secondary outcomes (3)
Reach-TM Engage
Proportion of patients that respond to the Text Messaging intervention
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
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
- 65,300 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
- NCT04939519
- Sponsor's protocol ID
- 00136001_2
- Other IDs
- 3UL1TR002538-03S2
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2021
- Last updated
- 12 Dec 2025
- 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 12 Dec 2025. 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
- NCT04939519
- Acronym / sponsor ID
- 00136001_2
- Conditions
- Covid19
- Keywords
- COVID19, Community Health, Health Information Technology, Population Health, Patient engagement, Rural, Scale up, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65,300 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 12 Dec 2025
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, 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:
- 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;
- 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:
- 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.
- 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 patient records to proactively reach patients for COVID-19 vaccinations. 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. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine.
Participants in the TM+PN condition will receive the same text message as the participants in the TM condition. Texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive the same information about how and where to receive a vaccine however, they will also receive a message alerting them that a Community Health Worker will contact them to assist with this process, in case they need that. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
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, patient 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 patients will be assigned to either the TM or TM+PN arm of the intervention. This assignment will remain consistent throughout the study. Cohort selection for the text messages will be based on EHR data considering factors such as age, race/ethnicity, language, relevant medical comorbidities, and residence in low-vaccination 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 who are eligible for COVID-19 vaccination. 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 patient cohort from the study database to send the texts to the patients. The text messages will appear to the patients as having originated from their Community Health Center. As part of their general Community Health Center care, patients 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 bi-weekly to continuously prompt vaccination update. This process will repeat until the participant indicates that they have either scheduled or received their vaccination. Every text message will include the option to reply STOP to opt-out of receiving text messages at any time.
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 who are eligible for the COVID-19 vaccine and proactively reach those participants for vaccine scheduling. This is a bi-directional text messaging system. |
| Text-Messaging plus Patient Navigation | 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 vaccination. |
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
- have a working cellphone,
- have phone number listed in existing electronic medical record at their 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)Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply "yes" will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply "no" will receive a text requesting they contact their local clinic when they decide to receive the vaccine. | Behavioural | Text-Messaging (TM), Text-Messaging plus Patient Navigation |
| Patient Navigation (PN)Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy. | Behavioural | Text-Messaging plus Patient Navigation |
Primary outcome
Uptake-Total
Time frame: 12 months
Proportion of patients who receive a COVID-19 vaccine out of the total patient population
3 secondary outcomes
Reach-TM Engage
Time frame: 12 months
Reach-PN Engage- Logistics Assistance
Time frame: 12 months
Reach-PN Engage- Requested Navigation
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 12 Dec 2025.
- 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 12 Dec 2025. 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 12 Dec 2025). 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?
Uptake-Total (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 12 Dec 2025.