COVID-19 Vaccine Uptake Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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RADx Up Safe Return to Schools: Strategies to Increase Vaccine Uptake

Conditions
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Vaccination Refusal, COVID-19

Intervention / Treatment
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* Other: Short Message Service (SMS) + Website Link Strategy
* Other: Phone Call with Peer Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is not up to date with their COVID-19 vaccinations per CDC guidelines is considered eligible by the CDC at the time of enrollment to receive a COVID-19 vaccine 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: Is currently up to date with their COVID-19 vaccinations per CDC guidelines ineligible to receive any COVID-19 vaccine due to medical history or age 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 participant (or their parents/LAR) do not provide consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short Message Service (SMS) with an associated link to a multi-media website<br>The participant will receive a SMS with a brief message containing the following: (1) statement encouraging them to get vaccinated and (2) a link to a multi-media page with videos and additional resources encouraging individuals to be vaccinated. The multi-media website will be housed in the Safe Return To School website and updated by a designated study team members. This page will include the following COVID-19-related resources: publicly available vaccine promotion videos, videos consisting of community members discussing vaccine topics, resources regarding local vaccine sites, and links to additional literature resources. | Other: Short Message Service (SMS) + Website Link Strategy<br>* The intervention we are evaluating is the effectiveness of a participant receiving a SMS + Website Link as a vaccine uptake strategy<br>|
| Active Comparator: Phone Call with Peer<br>The participant's peer will be a study team member who has the same or similar racial demographic as the participant. All team members conducting the peer phone calls will be trained in motivational interviewing. The participant will be called by their peer via zoom or phone. Motivational interviewing techniques will be utilized with the participant to promote vaccine uptake. The team member will use a facilitator guide throughout the peer intervention. | Other: Phone Call with Peer Strategy<br>* The intervention we are evaluating is the effectiveness of a participant having a phone call with a peer as a vaccine uptake strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine Uptake | The primary outcome of this study will be the percentage of individuals who received an initial 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. | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination with Full Dose | A secondary outcome will be the number of individuals that complete their primary vaccination series within 6 weeks of their first dose. | Up to 8 weeks |