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

NCT05533918 | Completed Results DMC

• 2 other identifiers: 00150669U01MD017421
• Study Type: interventional
• Target: 31,439
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Reach-Accept Testing

  Number of patients that accept an offer to receive an at-home test kit and verify mailing address

  Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

Secondary Outcomes (5)

• Reach-Engage Testing

  Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

• PN-Request

  Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

• PN-Engage

  Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

• Opt-out

  Daily [up to 90 days post intervention messaging)

• Self Reported Testing

  90 days post intervention messaging

Study Arms (2)

Text Messaging (TM) + No Patient Navigation

ACTIVE COMPARATOR

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.

Behavioral: Text-Messaging (TM)

Text Message (TM) + Request (RPN)

ACTIVE COMPARATOR

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.

Behavioral: Text-Messaging (TM); Behavioral: Patient Navigation (PN)

Interventions

Text-Messaging (TM) 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); Text Messaging (TM) + No Patient Navigation

Patient Navigation (PN) 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.

Text Message (TM) + Request (RPN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Minors

Sponsors & Collaborators

• University of Utah: lead
• Utah Department of Health: collaborator
• Association for Utah Community Health: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• 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.

  PMID: 40720824 DERIVED

• 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.

  PMID: 38508633 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Guilherme Del Fiol
• Organization: University of Utah

guilherme.delfiol@utah.edu

801-581-4080

Study Officials

• Guilherme Del Fiol, MD PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not know what intervention arm they are in.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patient-level, two-arm randomized design for Population Health Management interventions: (1) TM + No PN and (2) TM + Request PN

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 9, 2022
• Study Start: December 15, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)