An interventional study of Text-Messaging (TM) and Patient Navigation (PN) in Covid19, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by University of Utah · Not applicable, Interventional, and Screening
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:
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:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 65,300 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Text-Messaging (TM)
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.
Behavioral: Text-Messaging (TM) · Behavioral: Patient Navigation (PN)
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 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.
Uptake-Total
Proportion of patients who receive a COVID-19 vaccine out of the total patient population
Time frame: 12 months
Reach-TM Engage
Proportion of patients that respond to the Text Messaging intervention
Time frame: 12 months
Reach-PN Engage- Logistics Assistance
Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN
Time frame: 12 months
Reach-PN Engage- Requested Navigation
Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN
Time frame: 12 months
| Milestone | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation |
|---|---|---|
| Started | 32594 | 32706 |
| Completed | 32594 | 32706 |
| Not completed | 0 | 0 |
Proportion of patients who receive a COVID-19 vaccine out of the total patient population
| Participants | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation |
|---|---|---|
| Uptake-Total | 14308 | 14381 |
Proportion of patients that respond to the Text Messaging intervention
| Participants | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation |
|---|---|---|
| Reach-TM Engage | 5538 | 5587 |
Proportion of patients offered Logistics Assistance Patient Navigator (PN-LA) that talk to a PN
| Participants | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation |
|---|---|---|
| Reach-PN Engage- Logistics Assistance | 0 | 592 |
Proportion of patients offered Requested Navigation Patient Navigator (PN-RN) that talk to a PN
| Participants | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation |
|---|---|---|
| Reach-PN Engage- Requested Navigation | 0 | 122 |
Collected over This project used a non-systematic assessment method to evaluate adverse events. Although adverse events were not routinely assessed, data on adverse events were collected for up to 23 months after a participant's enrollment in the project.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Text-Messaging (TM) | 0/32,594 (0%) | 0/32,594 (0%) | 0/32,594 (0%) |
| Text-Messaging Plus Patient Navigation | 0/32,706 (0%) | 0/32,706 (0%) | 0/32,706 (0%) |
| Age, Customized(Participants) | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation | Total |
|---|---|---|---|
| 18-29 years old | 9210 | 9096 | 18306 |
| 30-64 years old | 19902 | 20033 | 39935 |
| 65 and older | 3482 | 3577 | 7059 |
| Sex/Gender, Customized(Participants) | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation | Total |
|---|---|---|---|
| Female | 17535 | 17376 | 34911 |
| Male | 13387 | 13687 | 27074 |
| Other or unknown | 1672 | 1643 | 3315 |
| Ethnicity (NIH/OMB)(Participants) | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation | Total |
|---|---|---|---|
| Hispanic or Latino | 12792 | 12820 | 25612 |
| Not Hispanic or Latino | 16201 | 16324 | 32525 |
| Unknown or Not Reported | 3601 | 3562 | 7163 |
| Race/Ethnicity, Customized(Participants) | Text-Messaging (TM) | Text-Messaging Plus Patient Navigation | Total |
|---|---|---|---|
| American Indian or Alaska Native White | 728 | 763 | 1491 |
| Asian | 206 | 241 | 447 |
| Black or African American | 380 | 330 | 710 |
| Native Hawaiian or Pacific Islander | 226 | 217 | 443 |
| More than one race | 444 | 445 | 889 |
| Other Race | 3602 | 3561 | 7163 |
| White | 21888 | 22002 | 43890 |
| Unknown or Not Reported | 5120 | 5147 | 10267 |
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