COVID-19, Vaccine Refusal
Conditions
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
Participants will be randomized to receive or not receive a text message encouraging COVID-19 vaccine uptake.
Participants will be randomized to receive either motivational interviewing when receiving SARS-CoV-2 antibody test results or standard interpretation of antibody results.
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | Baseline 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | Baseline to Month 2 | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 0 | 0 | 2 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Condition 1 | Condition 2 | Condition 3 | Condition 4 | Condition 5 | Condition 6 | Condition 7 | Condition 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.5 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 Participants | 4 Participants | 3 Participants | 1 Participants | 5 Participants | 3 Participants | 6 Participants | 5 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 37 Participants | 32 Participants | 32 Participants | 36 Participants | 27 Participants | 34 Participants | 37 Participants | 271 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 17 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 5 Participants | 5 Participants | 5 Participants | 2 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 1 Participants | 2 Participants | 5 Participants | 1 Participants | 2 Participants | 3 Participants | 19 Participants |
| Race (NIH/OMB) White | 32 Participants | 32 Participants | 32 Participants | 31 Participants | 28 Participants | 20 Participants | 28 Participants | 34 Participants | 237 Participants |
| Region of Enrollment United States | 42 participants | 42 participants | 35 participants | 35 participants | 42 participants | 31 participants | 41 participants | 44 participants | 312 participants |
| Sex: Female, Male Female | 27 Participants | 32 Participants | 31 Participants | 27 Participants | 32 Participants | 25 Participants | 31 Participants | 34 Participants | 239 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 4 Participants | 6 Participants | 9 Participants | 5 Participants | 10 Participants | 9 Participants | 65 Participants |
Adverse events
| Event type | EG000 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 / 42 | 0 / 42 | 0 / 35 | 0 / 35 | 0 / 42 | 0 / 31 | 0 / 41 | 0 / 44 |
| other Total, other adverse events | 0 / 42 | 0 / 42 | 0 / 35 | 0 / 35 | 0 / 42 | 0 / 31 | 0 / 41 | 0 / 44 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 35 | 0 / 35 | 0 / 42 | 0 / 31 | 0 / 41 | 0 / 44 |
Outcome results
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Condition 1 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 19 Participants |
| Condition 2 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 24 Participants |
| Condition 3 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 19 Participants |
| Condition 4 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 21 Participants |
| Condition 5 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 24 Participants |
| Condition 6 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 19 Participants |
| Condition 7 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 23 Participants |
| Condition 8 | Percentage of Participants Who Plan to Receive a COVID-19 Vaccine Post-intervention | 16 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Condition 1 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 2 Participants |
| Condition 2 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 1 Participants |
| Condition 3 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 0 Participants |
| Condition 4 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 0 Participants |
| Condition 5 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 2 Participants |
| Condition 6 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 1 Participants |
| Condition 7 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 0 Participants |
| Condition 8 | Percentage of Participants Who Self-report COVID-19 Vaccine Uptake | 0 Participants |