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OpenTrials
Completed

NCT Number: NCT05419232

COVID-19 Vaccine Uptake Trial

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.

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Key information

Conditions

Vaccination Refusal Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ferguson-Florissant School District, Hazelwood, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short Message Service (SMS) + Website Link Strategy

Other

The intervention we are evaluating is the effectiveness of a participant receiving a SMS + Website Link as a vaccine uptake strategy

Phone Call with Peer Strategy

Other

The intervention we are evaluating is the effectiveness of a participant having a phone call with a peer as a vaccine uptake strategy

Primary outcomes

  1. Vaccine Uptake

    Time frame: 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 outcomes

  1. Vaccinated or Indicated They Would Receive Vaccine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 15, 2022
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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