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

SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Testing and Vaccination Among Utah Community Health Centers

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: Text-Messaging (TM); Behavioral: Patient Navigation (PN); Behavioral: Conversational Agent (CA)

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: CA 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 2x2 design with patients being initially randomized between receiving either text messages or the link to a conversational agent as well as into two distinct types of available patient navigation, Request-PN or No PN.

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

Conversational Agent (CA): automated, scripted and interactive agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits.

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/conversational agent. Patients who are randomized to receive No PN will not be provided the opportunity to speak with a patient navigator.

The primary outcome, Reach-Accept Testing, captures whether patients requests an at-home test kit and confirmed their mailing address. Secondary outcomes include: Testing (i.e. the proportion of participants who self-report having used an at-home test at least once during follow-up) as well as several implementation outcomes including Reach-Engage Testing (proportion of patients that reply to an offer to receive an at-home rapid test kit), PN-Request (proportion in PN who requested patient navigation), PN-Engage (proportion in PB who talked to a patient navigator), and Opt-Out. The outcomes and compared groups provided for the Smartphone study are main effects for delivery mechanism (Chatbot & TM), main effects for PN (PN & No PN), and main effects for message frequency (10-day & 30-day).

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.

• Study Type: Interventional
• Enrollment (Actual): 2117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.; Behavioral: Patient Navigation (PN); Participants in the PN condition will receive a call from a Community Health Worker to assist with the process of receiving a COVID test. 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 testing such as logistics, as well as fear, skepticism, and hesitancy. There are two distinct different types of patient navigation. A person can be randomly assigned to either type, or no PN, or a combination of the two types.
Active Comparator: Conversational Agent (CA)+ No Patient Navigation; Automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Patients will not receive patient navigation.	Behavioral: Conversational Agent (CA); Patients in the CA condition will receive a link to an automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits.
Active Comparator: Conversational Agent (CA) + Request PN (RPN); Automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a CA offering connection to testing and/or vaccination.	Behavioral: Patient Navigation (PN); Participants in the PN condition will receive a call from a Community Health Worker to assist with the process of receiving a COVID test. 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 testing such as logistics, as well as fear, skepticism, and hesitancy. There are two distinct different types of patient navigation. A person can be randomly assigned to either type, or no PN, or a combination of the two types.; Behavioral: Conversational Agent (CA); Patients in the CA condition will receive a link to an automated, scripted and interactive conversational agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-Accept Testing	Number of patients who requested a test kit and confirmed their mailing address.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-Engage Testing	Number of patients that reply to an offer to receive an at-home rapid test kit	Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]
PN-Request	Number of participants who were assigned to PN groups who requested patient navigation.	Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]
PN-Engage	Number of participants who were in PN groups who talked to a patient navigator.	Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]
Opt Out	Number of participants who replied to stop receiving study interventions. Participants could opt-out at any time regardless of message timing.	Daily [up to 90 days post intervention message]
Self-reported Testing	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.	90 days post intervention message

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH); Utah Department of Health; Association for Utah Community Health
• Investigators: Principal Investigator: Guilherme Del Fiol, MD PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 00150669_2; U01MD017421 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No