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CATCH-UP Vaccines: Engaged Approaches to Testing in Community/Healthcare Settings for the Underserved (COVID-19)

CATCH-UP Vaccines: Extension of Community - Engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05236270
Enrollment
312
Registered
2022-02-11
Start date
2022-03-25
Completion date
2023-08-26
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Vaccine Refusal

Keywords

COVID-19 Vaccine Hesitancy, MOST (multiphase optimization strategy)

Brief summary

Oklahoma has high COVID-19 incidence, particularly among underserved minority and rural Oklahomans. Oklahoman's are also reporting SARS-CoV-2 vaccine hesitancy and signs of slowing vaccine uptake, with increased hesitancy among American Indian and rural populations. The project aims to work with ongoing community testing events to implement interventions to improve vaccine uptake among Oklahoma's underserved populations.

Detailed description

This proposal unites academic and community partners to solve a dire need for SARS-CoV-2 vaccine uptake in rural, underserved minority, and at-risk populations. Oklahoma has high COVID-19 incidence, high vaccine hesitancy, and signs of a slowing SARS-CoV-2 vaccine uptake. Oklahoma's cumulative incidence is higher in rural compared to urban counties. AI people have a higher incidence of COVID-19 compared to white populations in Oklahoma. Despite high incidence, as of April 2021, an estimated 54% of Oklahomans who have not yet been vaccinated reported unwillingness to receive the SARS-CoV-2 vaccine. Vaccine hesitancy was even greater in AI people (62%). The most commonly reported concerns are vaccine side effects and safety (30%). Despite early progress in disseminating vaccines in Oklahoma, all signs point to waning interest in receiving a vaccine, with many vaccine clinics unable to fill all available slots, particularly in tribal clinics and rural areas. This proposal is an extension of the Oklahoma Shared Clinical Translational Resources (OSCTR) project CATCH-UP (Community-engaged Approaches to Testing in Community and Healthcare settings for Underserved Populations) in partnership with community organizations who work with underserved minority and rural populations. This project will build on existing strengths and infrastructure to improve SARS-CoV-2 vaccine uptake in these highly susceptible populations. The goal of the project is to pilot interventions to improve awareness and uptake of COVID-19 vaccination. The project aims to work with CATCH-UP community events to implement interventions to improve vaccine uptake among Oklahoma's underserved populations. To do so, the proposed study employs a multiphase optimization strategy (MOST). The proposed study uses the preparation and optimization phases of the MOST framework across the following aims: 1) Identify SARS-CoV-2 vaccination barriers/facilitators and assess acceptability and feasibility of a suite of evidence-based vaccine intervention strategies among Oklahoma's rural, minority, and high-risk populations to inform a targeted multicomponent intervention; and 2) Develop and optimize a multicomponent intervention to improve SARS-CoV-2 vaccination among Oklahoman's seeking SARS-CoV-2 testing at CATCH-UP testing events. Investigators will conduct a pilot of these interventions based on community input, which will be evaluated for inclusion in a future, full-scale implementation study.

Interventions

BEHAVIORALText Message

Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.

BEHAVIORALMotivational Interviewing

Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.

BEHAVIORALElectronic Educational Message with Tailored Questions/Prompts

Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Investigators who are providing the intervention and conducting analysis will be masked to study assignment

Intervention model description

Interventions will address three primary areas to improve vaccination uptake: (1) process (text messages); (2) teachable moment messaging (motivational interviewing); and (3) barrier elicitation and reduction (electronic survey with tailored questions/prompts). In a factorial research design, two or more independent variables are concurrently examined within the same trial. The three factors are crossed with one another to create a total of eight experimental conditions. An equal number of sites are randomly assigned to each condition, using a random number generator.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

1. 18 years of age and older 2. Must be eligible to receive a COVID-19 vaccine dose at the time of consent based on the following criteria: a. Eligible for one bivalent mRNA vaccine i. No previous doses of any COVID-19 vaccine ii. At least 8 weeks since a previous vaccine dose of any manufacturer b. Eligible for second bivalent mRNA vaccine i. Adults 65 year of age and older can receive one additional bivalent mRNA vaccine at least 4 months after the first dose of a bivalent mRNA vaccine. ii. Those who are immunocompromised can receive one additional bivalent mRNA vaccine at least 2 months after the first dose of a bivalent mRNA vaccine. 3. Ability to read and speak English

Exclusion criteria

1. Those who have received all eligible doses of any approved COVID-19 vaccine. 2. Those with active COVID-19 disease (either through self-reported positive test within the last 10 days or viral test at the event if available).

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-interventionBaseline to Post-Intervention Survey (approximately 15-30 minutes)Investigators will measure this with the question How likely are you to get an approved COVID-19 vaccine? and If you have received 1 dose of the Janssen vaccine or 2 doses of the Moderna or Pfizer vaccine, how likely are you to get an approved booster shot? We will compare intention to receive a COVID-19 vaccine or booster among those receiving the interventions compared to those not receiving the intervention

Secondary

MeasureTime frameDescription
Percentage of Participants Who Self-report COVID-19 Vaccine UptakeBaseline to Month 2The secondary outcome will be vaccine uptake, including self-report of receiving an initial dose of any approved vaccine, two doses of Pfizer or Moderna vaccines, or a booster of any approved vaccine.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from March 25, 2022 through June 27, 2023 from 21 sites across Oklahoma. Recruitment sites included community events, employee wellness events at healthcare facilities, and conferences.

Pre-assignment details

After participants provided informed consent and HIPAA authorization, participants were randomized to a treatment condition.

Participants by arm

ArmCount
Condition 1
Participants will not receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an attention control educational message.
42
Condition 2
Participants will not receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an educational message about COVID-19 vaccines. Electronic Educational Message with Tailored Questions/Prompts: Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.
42
Condition 3
Patients will not receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an attention control educational message. Motivational Interviewing: Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.
35
Condition 4
Patients will not receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with vaccination discussion, and an educational message about COVID-19 vaccines. Motivational Interviewing: Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results. Electronic Educational Message with Tailored Questions/Prompts: Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.
35
Condition 5
Patients will receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with vaccination discussion, and an educational message about COVID-19 vaccines. Text Message: Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake. Motivational Interviewing: Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results. Electronic Educational Message with Tailored Questions/Prompts: Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.
42
Condition 6
Patients will receive a text message notifying participants about COVID-19 vaccine availability, motivational interviewing about serology SARS-CoV-2 antibody results with vaccination discussion, and an attention control educational message. Text Message: Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake. Motivational Interviewing: Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.
31
Condition 7
Patients will receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an attention control educational message. Text Message: Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
41
Condition 8
Patients will receive a text message notifying participants about COVID-19 vaccine availability, standard interpretation of serology SARS-CoV-2 antibody results with COVID-19 vaccination discussion, and an educational message about COVID-19 vaccines. Text Message: Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake. Electronic Educational Message with Tailored Questions/Prompts: Participants will be randomized to receive either an electronic educational message tailored to their COVID-19 vaccine concerns and vaccine status or an attention control message about overall healthy choices.
44
Total312

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Overall StudyLost to Follow-up32002013

Baseline characteristics

CharacteristicCondition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Total
Age, Continuous43.5 years
STANDARD_DEVIATION 12.5
47.0 years
STANDARD_DEVIATION 14.5
52.4 years
STANDARD_DEVIATION 13.4
46.8 years
STANDARD_DEVIATION 14.3
44.7 years
STANDARD_DEVIATION 14.2
47.1 years
STANDARD_DEVIATION 12.8
44.4 years
STANDARD_DEVIATION 14.4
43.3 years
STANDARD_DEVIATION 14.4
46.0 years
STANDARD_DEVIATION 14
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants4 Participants3 Participants1 Participants5 Participants3 Participants6 Participants5 Participants31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants37 Participants32 Participants32 Participants36 Participants27 Participants34 Participants37 Participants271 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants0 Participants2 Participants1 Participants1 Participants1 Participants2 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants4 Participants0 Participants2 Participants1 Participants3 Participants3 Participants3 Participants17 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants3 Participants
Race (NIH/OMB)
Black or African American
3 Participants3 Participants1 Participants0 Participants5 Participants5 Participants5 Participants2 Participants24 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants1 Participants0 Participants2 Participants2 Participants3 Participants1 Participants12 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants1 Participants1 Participants2 Participants5 Participants1 Participants2 Participants3 Participants19 Participants
Race (NIH/OMB)
White
32 Participants32 Participants32 Participants31 Participants28 Participants20 Participants28 Participants34 Participants237 Participants
Region of Enrollment
United States
42 participants42 participants35 participants35 participants42 participants31 participants41 participants44 participants312 participants
Sex: Female, Male
Female
27 Participants32 Participants31 Participants27 Participants32 Participants25 Participants31 Participants34 Participants239 Participants
Sex: Female, Male
Male
13 Participants9 Participants4 Participants6 Participants9 Participants5 Participants10 Participants9 Participants65 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 420 / 350 / 350 / 420 / 310 / 410 / 44
other
Total, other adverse events
0 / 420 / 420 / 350 / 350 / 420 / 310 / 410 / 44
serious
Total, serious adverse events
0 / 420 / 420 / 350 / 350 / 420 / 310 / 410 / 44

Outcome results

Primary

Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention

Investigators will measure this with the question How likely are you to get an approved COVID-19 vaccine? and If you have received 1 dose of the Janssen vaccine or 2 doses of the Moderna or Pfizer vaccine, how likely are you to get an approved booster shot? We will compare intention to receive a COVID-19 vaccine or booster among those receiving the interventions compared to those not receiving the intervention

Time frame: Baseline to Post-Intervention Survey (approximately 15-30 minutes)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Condition 1Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention19 Participants
Condition 2Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention24 Participants
Condition 3Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention19 Participants
Condition 4Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention21 Participants
Condition 5Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention24 Participants
Condition 6Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention19 Participants
Condition 7Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention23 Participants
Condition 8Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention16 Participants
Secondary

Percentage of Participants Who Self-report COVID-19 Vaccine Uptake

The secondary outcome will be vaccine uptake, including self-report of receiving an initial dose of any approved vaccine, two doses of Pfizer or Moderna vaccines, or a booster of any approved vaccine.

Time frame: Baseline to Month 2

Population: Analysis includes participants who completed the 60-day follow-up survey (n=47)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Condition 1Percentage of Participants Who Self-report COVID-19 Vaccine Uptake2 Participants
Condition 2Percentage of Participants Who Self-report COVID-19 Vaccine Uptake1 Participants
Condition 3Percentage of Participants Who Self-report COVID-19 Vaccine Uptake0 Participants
Condition 4Percentage of Participants Who Self-report COVID-19 Vaccine Uptake0 Participants
Condition 5Percentage of Participants Who Self-report COVID-19 Vaccine Uptake2 Participants
Condition 6Percentage of Participants Who Self-report COVID-19 Vaccine Uptake1 Participants
Condition 7Percentage of Participants Who Self-report COVID-19 Vaccine Uptake0 Participants
Condition 8Percentage of Participants Who Self-report COVID-19 Vaccine Uptake0 Participants

Source: ClinicalTrials.gov · Data processed: May 11, 2026