COVID-19, Vaccination Refusal
Conditions
Brief summary
The goal of this study is to assess the best COVID-19 vaccine uptake strategy among students, staff and household members that have not been vaccinated. There is a multitude of recommendations present that highlight different vaccination strategy; however, it is still unclear which strategy is best to increase COVID-19 vaccination rates. We will compare the effectiveness and acceptance of two different communication strategies among unvaccinated students, staff, and their household members.
Detailed description
A sequential multiple assignment randomized trial (SMART) will be conducted to assess two strategies to increase COVID-19 vaccine uptake. The two strategies that will be assessed are a text message with a link to an information website and peer-based motivational interview. If individuals do not seek vaccination after the first intervention, they will again be randomized into the same two interventions. This will allow for testing of both interventions as well as understanding if the use of a more intense intervention (two 'doses') is optimal for vaccine uptake. In addition, SARS-CoV-2 saliva-based testing will be conducted among students, staff, and household members from the summer of 2022 through the first semester of the 2022-2023 school year. As the pandemic is in its third year, the use of testing among students, staff, and their household members will be assessed Individuals are eligible to be tested multiple times and the testing will occur along different timelines.
Interventions
OTHERShort Message Service (SMS) + Website Link Strategy
The intervention we are evaluating is the effectiveness of a participant receiving a SMS + Website Link as a vaccine uptake strategy
OTHERPhone Call with Peer Strategy
The intervention we are evaluating is the effectiveness of a participant having a phone call with a peer as a vaccine uptake strategy
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Is not up to date with their COVID-19 vaccinations per CDC guidelines 2. is considered eligible by the CDC at the time of enrollment to receive a COVID-19 vaccine 3. is a staff, student, or household member of staff or student of one of the participating school districts OR a resident of St. Louis City or St. Louis County
Exclusion criteria
1. Is currently up to date with their COVID-19 vaccinations per CDC guidelines 2. ineligible to receive any COVID-19 vaccine due to medical history or age 3. is not a staff or student, or household member of staff or student of one of the participating school districts AND is not a resident of St. Louis City or St. Louis County 4. participant (or their parents/LAR) do not provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine Uptake | Up to 8 weeks | The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccinated or Indicated They Would Receive Vaccine | Up to 8 weeks | The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination or indicated they would receive any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member. |
Countries
United States
Participant flow
Recruitment details
Individuals were recruited from previous COVID-19 testing studies. Individuals were eligible for the study if they were an employee, student, or a family member of a student or employees from nine school districts and charter schools in St. Louis or if they were a resident of St. Louis City or County and were completely unvaccinated for COVID-19. Eligibility expanded to include individuals that were not up to date for their COVID-19 vaccine.
Pre-assignment details
1558 families were called for recruitment, 666 families were screened, 262 individuals were consented, 251 participants received first randomization
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Call + Call Participants were randomized to Call at timepoint one and Call at timepoint two | 56 |
| Group 2: Call + Text Participants were randomized to Call at timepoint one and Text at timepoint two. | 63 |
| Group 3: Text + Call Participants were randomized to Text at timepoint one and Call at timepoint two. | 52 |
| Group 4: Text + Text Participants were randomized to Text at timepoint one and Text at timepoint two. | 71 |
| Group 5: Call Only Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew. | 6 |
| Group 6: Text Only Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew. | 3 |
| Total | 251 |
Baseline characteristics
| Characteristic | Group 1: Call + Call | Group 2: Call + Text | Group 3: Text + Call | Group 4: Text + Text | Group 5: Call Only | Group 6: Text Only | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38 Years | 21 Years | 39 Years | 30 Years | 47 Years | 35 Years | 35 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 54 Participants | 50 Participants | 68 Participants | 6 Participants | 3 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 31 Participants | 29 Participants | 33 Participants | 1 Participants | 2 Participants | 135 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 9 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) White | 14 Participants | 23 Participants | 18 Participants | 32 Participants | 4 Participants | 1 Participants | 92 Participants |
| Received COVID-19 Vaccine No | 32 Participants | 35 Participants | 32 Participants | 34 Participants | 2 Participants | 2 Participants | 137 Participants |
| Received COVID-19 Vaccine Yes | 24 Participants | 28 Participants | 20 Participants | 37 Participants | 4 Participants | 1 Participants | 114 Participants |
| Sex/Gender, Customized Female | 44 Participants | 35 Participants | 35 Participants | 47 Participants | 6 Participants | 2 Participants | 169 Participants |
| Sex/Gender, Customized Male | 12 Participants | 28 Participants | 17 Participants | 23 Participants | 0 Participants | 1 Participants | 81 Participants |
| Sex/Gender, Customized Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 63 | 0 / 52 | 0 / 71 | 0 / 6 | 0 / 3 |
| other Total, other adverse events | 0 / 56 | 0 / 63 | 0 / 52 | 0 / 71 | 0 / 6 | 0 / 3 |
| serious Total, serious adverse events | 0 / 56 | 0 / 63 | 0 / 52 | 0 / 71 | 0 / 6 | 0 / 3 |
Outcome results
Primary
Vaccine Uptake
The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.
Time frame: Up to 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Call + Call | Vaccine Uptake | 1 Participants |
| Group 2: Call + Text | Vaccine Uptake | 3 Participants |
| Group 3: Text + Call | Vaccine Uptake | 1 Participants |
| Group 4: Text + Text | Vaccine Uptake | 0 Participants |
| Group 5: Call Only | Vaccine Uptake | 2 Participants |
| Group 6: Text Only | Vaccine Uptake | 0 Participants |
Secondary
Vaccinated or Indicated They Would Receive Vaccine
The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination or indicated they would receive any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.
Time frame: Up to 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Call + Call | Vaccinated or Indicated They Would Receive Vaccine | 7 Participants |
| Group 2: Call + Text | Vaccinated or Indicated They Would Receive Vaccine | 7 Participants |
| Group 3: Text + Call | Vaccinated or Indicated They Would Receive Vaccine | 4 Participants |
| Group 4: Text + Text | Vaccinated or Indicated They Would Receive Vaccine | 1 Participants |
| Group 5: Call Only | Vaccinated or Indicated They Would Receive Vaccine | 2 Participants |
| Group 6: Text Only | Vaccinated or Indicated They Would Receive Vaccine | 0 Participants |