COVID-19 Vaccine Uptake Trial

Not Applicable

Completed

• Conditions: COVID-19; Vaccination Refusal
• Interventions: Other: Short Message Service (SMS) + Website Link Strategy; Other: Phone Call with Peer Strategy

• Registration Number: NCT05419232
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2022-06-11
• Study First Submitted QC: 2022-06-11
• Study First Posted: 2022-06-15
• Study Start: 2022-07-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-31
• Results First Submitted: 2025-01-27
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Results First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Message Service (SMS) with an associated link to a multi-media website	Short Message Service (SMS) + Website Link Strategy	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.
Phone Call with Peer	Phone Call with Peer Strategy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Ferguson-Florissant School District; 🇺🇸 Hazelwood, Missouri, United States

Jennings School District; 🇺🇸 Jennings, Missouri, United States

St. Louis Language Immersion School; 🇺🇸 Saint Louis, Missouri, United States

Pattonville School District; 🇺🇸 Saint Ann, Missouri, United States

Normandy Schools Collaborative; 🇺🇸 Saint Louis, Missouri, United States

Ritenour School District; 🇺🇸 Saint Louis, Missouri, United States

University City School District; 🇺🇸 University City, Missouri, United States

Maplewood Richmond Heights School District; 🇺🇸 Saint Louis, Missouri, United States