Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05533918 |
| Other study ID # |
00150669 |
| Secondary ID |
U01MD017421 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2022 |
| Est. completion date |
November 30, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
The primary outcome, Testing, captures whether patients actually test with the mailed at-home
test kit. Secondary outcomes include: Time-To-Vaccine (time-to-event outcome) 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) and Reach-Accept Testing (proportion
of patients that accept an offer to receive an at-home test kit). A similar set of
implementation outcomes will be measured for vaccination (i.e., Reach-Engage Vaccine and
Reach-Accept Vaccine).
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.
