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NCT05533359

SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Conversational Agent Study

Completed NA Results posted Last updated 15 January 2025
What this trial tests

NA trial testing Text-Messaging (TM) in COVID-19 in 2,117 participants. Completed in 30 November 2023.

Timeline
15 January 2023
Primary endpoint
30 November 2023
30 November 2023

Quick facts

Lead sponsorUniversity of Utah
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposescreening
Enrollment2,117
Start date15 January 2023
Primary completion30 November 2023
Estimated completion30 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reach-Accept Testing Primary · Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message] Every 10 or 30 days from intervention messaging for 90 days dependent on group randomization.

Number of patients who requested a test kit and confirmed their mailing address.

GroupValue95% CI
Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day47
Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day41
Conversational Agent (CA) + Patient Navigation (PN) + 10 Day41
Conversational Agent (CA) + Patient Navigation (PN) + 30 Day45
Text Message (TM) + No Patient Navigation (NoPN) + 10 Day142
Text Message (TM) + No Patient Navigation (NoPN) + 30 Day139
Text Message (TM) + Patient Navigation (PN) + 10 Day151
Text Message (TM) + Patient Navigation (PN) + 30 Day123
Reach-Engage Testing Secondary · Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

Number of patients that reply to an offer to receive an at-home rapid test kit

GroupValue95% CI
Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day90
Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day73
Conversational Agent (CA) + Patient Navigation (PN) + 10 Day78
Conversational Agent (CA) + Patient Navigation (PN) + 30 Day68
Text Message (TM) + No Patient Navigation (NoPN) + 10 Day155
Text Message (TM) + No Patient Navigation (NoPN) + 30 Day154
Text Message (TM) + Patient Navigation (PN) + 10 Day171
Text Message (TM) + Patient Navigation (PN) + 30 Day145
PN-Request Secondary · Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

Number of participants who were assigned to PN groups who requested patient navigation.

GroupValue95% CI
Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day0
Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day0
Conversational Agent (CA) + Patient Navigation (PN) + 10 Day3
Conversational Agent (CA) + Patient Navigation (PN) + 30 Day3
Text Message (TM) + No Patient Navigation (NoPN) + 10 Day0
Text Message (TM) + No Patient Navigation (NoPN) + 30 Day0
Text Message (TM) + Patient Navigation (PN) + 10 Day3
Text Message (TM) + Patient Navigation (PN) + 30 Day1
PN-Engage Secondary · Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]

Number of participants who were in PN groups who talked to a patient navigator.

GroupValue95% CI
Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day0
Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day0
Conversational Agent (CA) + Patient Navigation (PN) + 10 Day2
Conversational Agent (CA) + Patient Navigation (PN) + 30 Day2
Text Message (TM) + No Patient Navigation (NoPN) + 10 Day0
Text Message (TM) + No Patient Navigation (NoPN) + 30 Day0
Text Message (TM) + Patient Navigation (PN) + 10 Day2
Text Message (TM) + Patient Navigation (PN) + 30 Day0
Opt Out Secondary · Daily [up to 90 days post intervention message]

Number of participants who replied to stop receiving study interventions. Participants could opt-out at any time regardless of message timing.

GroupValue95% CI
Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day14
Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day2
Conversational Agent (CA) + Patient Navigation (PN) + 10 Day27
Conversational Agent (CA) + Patient Navigation (PN) + 30 Day13
Text Message (TM) + No Patient Navigation (NoPN) + 10 Day23
Text Message (TM) + No Patient Navigation (NoPN) + 30 Day3
Text Message (TM) + Patient Navigation (PN) + 10 Day15
Text Message (TM) + Patient Navigation (PN) + 30 Day9
Self-reported Testing Secondary · 90 days post intervention message

Participant self-reported testing as completed. Reported only for participants who requested COVID-19 test kits from the study and responded to follow-up messages.

GroupValue95% CI
Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day18
Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day16
Conversational Agent (CA) + Patient Navigation (PN) + 10 Day13
Conversational Agent (CA) + Patient Navigation (PN) + 30 Day13
Text Message (TM) + No Patient Navigation (NoPN) + 10 Day32
Text Message (TM) + No Patient Navigation (NoPN) + 30 Day37
Text Message (TM) + Patient Navigation (PN) + 10 Day41
Text Message (TM) + Patient Navigation (PN) + 30 Day25

Sponsor's own description

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. Thus, the UofU team is uniquely positioned to lead this project.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Population-Based Digital Health Interventions to Deliver at-Home COVID-19 Testing: SCALE-UP II Randomized Clinical Trial.
    Del Fiol G, Kuzmenko TV, Orleans B, Chipman JJ, et al · · 2025 · cited 2× · PMID 40720824 · DOI 10.2196/74145
  2. 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.
    Del Fiol G, Orleans B, Kuzmenko TV, Chipman J, et al · · 2024 · cited 1× · PMID 38508633 · DOI 10.1136/bmjopen-2023-081455

Verify or expand the search:

Other trials of Text-Messaging (TM)

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05533359.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing