SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Text Message Study

NCT ID: NCT05533918

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31439 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-11-30

Brief Summary

The long-term objective of SCALE-UP II is to increase the reach, uptake, and sustainability of COVID-19 testing among underserved populations. Through RADx-UP Phase I funding (SCALE-UP Utah), the team has established population health management (PHM) interventions that have been used since Feb 2021 to increase the uptake of COVID-19 testing and vaccination among community health center patients.

Interventions are based on a PHM approach that uses widely available technology (i.e. cell phones and text messaging). SCALE-UP II will both build on SCALE-UP Utah PHM interventions and investigate novel resource conservation approaches (i.e., Request-Patient Navigation vs. No Patient Navigation and text messaging vs. conversational agent).

SCALE-UP II builds on long standing partnerships among the University of Utah Clinical and Translational Science Institute (UofU CTSI), Association for Utah Community Health (AUCH), CHCs, and the Utah Department of Health(UDOH). CTSI and SCALE-UP II investigators are leading several COVID-19 initiatives that drive public health response and state government policies in Utah.

Detailed Description

Racial/ethnic minority, low socioeconomic status (SES), and rural populations suffer profound health inequities across a wide variety of diseases and conditions, including COVID-19. For example, as of June 2021, the cumulative COVID case rate in Utah per 100,000 was 10,803 among Whites vs. 17,541 among Latinos. The positivity rate was 14% among Whites vs. 24% among Latinos. Similar disparities persist across the nation for vaccination rates between urban vs. rural, high vs. low SES, and White vs. non-White populations. Low vaccination rates leave underserved populations at risk for local outbreaks, and more contagious and severe variants. Thus, interventions targeting these populations at the interplay between testing and vaccination among underserved populations are critical for pandemic control.

Not only do underserved populations experience profound health inequities, but there is also a critical digital divide between high and low resource healthcare systems. Low resource settings are far less likely to adopt Health Information Technology approaches, and often do not have the capacity to implement large scale population health management (PHM) efforts utilizing data analytics and automated patient outreach. As such, research is needed utilizing targeted PHM approaches that proactively identify, reach, and navigate vulnerable patients to both increase opportunities to engage in vaccination and testing, and to address barriers to engagement. Community Health Centers (CHCs) are optimal settings for implementation of PHM interventions to increase the uptake of COVID-19 testing and vaccination among underserved populations. Eleven Utah CHC systems are participating in SCALE-UP II. Their 38 primary care clinics serve over 112,000 unique patients annually (36% Latino, 10% Native American, 63% <100% poverty level, 57% uninsured, and 42% of clinics are in rural/frontier areas).

SCALE UP II is comprised of two distinct studies, the Text Message (TM) study and the Conversational Agent (CA) study. Patients will be triaged into one of two studies based on self-reported ownership of a smart phone with internet access. Patients who report not owning a smart phone with internet access will be included in the TM study. Additionally, patients who do not respond to the question regarding smart phone ownership will be included in the TM study. Patients who self-report ownership of a smart phone with internet access will be included in the CA study.

SCALE-UP II: TM study will implement and evaluate practical, accessible, and scalable PHM interventions to increase COVID-19 testing and vaccine uptake based on the best evidence available, patients' specific barriers and hesitancy factors, and extensive collaboration with CHCs, AUCH, and UDHHS. This study is a 1x2 design with all patients receiving text messages as well as either type of available patient navigation.

Text Messaging (TM): bidirectional text messaging to connect patients to vaccination or mailed at-home rapid test kits for use, as needed.

Patient Navigation (PN): phone call from a community health worker to help address hesitancy and barriers, and to offer at-home rapid test kits. This study will examine two distinct forms of Patient Navigation: Request-PN and No PN. Each patient will be randomized to receive either Request PN or No PN. Request PN allows patients to request patient navigation by responding PERSON to a text message. Patients who are randomized to receive No PN will not be provided the opportunity to speak with a patient navigator.

This study examined the main effects for PN (PN & No PN) and message frequency (10-day & 30-day). Vaccine response was not examined.

The primary outcome, Reach-Accept Testing, captures the proportion of participants who request a test and confirm their mailing address. Secondary outcomes include: Reach-Engage Testing (proportion of patients that reply to an offer to receive an at-home rapid test kit), Patient Navigation- Request (proportion of PN participants that request a patient navigator), Patient Navigation-Engage (proportion of PN participants that speak to a patient navigator) and Self-reported testing (participants that request a COVID-19 test kit and respond to follow up messaging).

SCALE-UP II will include a Consortium Data Reporting Unit (CDRU) consisting of a Data Manager and one member the project's biomedical informatics team. The unit will attend regular meetings and dissemination activities organized by the CDCC. The CDRU will seek guidance from the CDCC with regard to data acquisition and consent for data sharing. As required by the NIH, SCALE-UP II will collect RADx-UP Tier 1 Common Data Elements for study participants who receive an at-home COVID test through the project. These data will be collected through surveys administered one month after the participant receives their at-home test. Data will be standardized according to the data dictionary provided by the CDCC. Our CDRU will work closely with the CDCC to establish a protocol for frequency, format, and exchange of data. SCALE-UP II will share identifiable data with the CDCC and NIH for the Data Hub as well as future research. Participants who complete the survey data will first complete an informed consent process. The informed consent will be administered to the patient at the time of survey collection.

Lighthouse Research and Development will conduct phone surveys to assess patient reported use of COVID-19 at-home testing (~2,300 participants) among patients who received test kits and do no respond to the online survey request. Lighthouse will send notifications (e.g., postcards, text messages, voice messages, etc.) to participants to alert them of the opportunity to complete the survey online or over the phone. Interviewers will complete up to 15 call attempts across weekday, evening, and weekend calling shifts over a one-month period to each participant. Patients will be compensated with a gift card for completing the survey. Patients will be compensated with a gift card for completing the survey.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Text Messaging (TM) + No Patient Navigation

Bidirectional text messaging with a one-touch response to connect patients to vaccination or mailed at-home rapid test kits for use as needed.

Patients will not receive patient navigation.

Group Type: ACTIVE_COMPARATOR

Text-Messaging (TM)

Intervention Type: BEHAVIORAL

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 a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.

Text Message (TM) + Request (RPN)

Bidirectional text messaging with a one-touch response to connect patients to vaccination or mailed at-home rapid test kits for use as needed.

RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.

Group Type: ACTIVE_COMPARATOR

Text-Messaging (TM)

Intervention Type: BEHAVIORAL

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 a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.

Patient Navigation (PN)

Intervention Type: BEHAVIORAL

Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.

There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.

Interventions

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 a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.

Intervention Type: BEHAVIORAL

Patient Navigation (PN)

Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.

There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Utah Department of Health

OTHER

Sponsor Role: collaborator

Association for Utah Community Health

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Del Fiol

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guilherme Del Fiol, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

Del Fiol G, Kuzmenko TV, Orleans B, Chipman JJ, Greene T, Meads R, Kaphingst KA, Gibson B, Kawamoto K, King AJ, Siaperas T, Hughes S, Pruhs A, Dinkins CP, Lam CY, Pierce JH, Benson R, Borsato EP, Cornia RC, Stevens L, Bradshaw RL, Schlechter CR, Wetter DW. Population-Based Digital Health Interventions to Deliver at-Home COVID-19 Testing: SCALE-UP II Randomized Clinical Trial. J Med Internet Res. 2025 Jul 28;27:e74145. doi: 10.2196/74145.

Reference Type: DERIVED

PMID: 40720824 (View on PubMed)

Del Fiol G, Orleans B, Kuzmenko TV, Chipman J, Greene T, Martinez A, Wirth J, Meads R, Kaphingst KK, Gibson B, Kawamoto K, King AJ, Siaperas T, Hughes S, Pruhs A, Pariera Dinkins C, Lam CY, Pierce JH, Benson R, Borsato EP, Cornia R, Stevens L, Bradshaw RL, Schlechter CR, Wetter DW. SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres. BMJ Open. 2024 Mar 20;14(3):e081455. doi: 10.1136/bmjopen-2023-081455.

Reference Type: DERIVED

PMID: 38508633 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U01MD017421

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00150669

Identifier Type: -

Identifier Source: org_study_id