COVID-19 Vaccine Uptake Trial

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Ferguson-Florissant School District
    • Jennings, Missouri, United States, 63136
      • Jennings School District
    • Saint Ann, Missouri, United States, 63074
      • Pattonville School District
    • Saint Louis, Missouri, United States, 63121
      • Normandy Schools Collaborative
    • Saint Louis, Missouri, United States, 63103
      • St. Louis Language Immersion School
    • Saint Louis, Missouri, United States, 63114
      • Ritenour School District
    • Saint Louis, Missouri, United States, 63144
      • Maplewood Richmond Heights School District
    • University City, Missouri, United States, 63130
      • University City School District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Short Message Service (SMS) with an associated link to a multi-media website; 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; The intervention we are evaluating is the effectiveness of a participant receiving a SMS + Website Link as a vaccine uptake strategy
Active Comparator: Phone Call with Peer; 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; The intervention we are evaluating is the effectiveness of a participant having a phone call with a peer as a vaccine uptake strategy

What is the study measuring?

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 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.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• Milkman KL, Patel MS, Gandhi L, Graci HN, Gromet DM, Ho H, Kay JS, Lee TW, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris CF, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2101165118. doi: 10.1073/pnas.2101165118.
• Almirall D, Nahum-Shani I, Sherwood NE, Murphy SA. Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research. Transl Behav Med. 2014 Sep;4(3):260-74. doi: 10.1007/s13142-014-0265-0.
• Centers for Disease Control and Prevention. COVID-19; 2022, https://www.cdc.gov/coronavirus/2019-ncov/index.html. Accessed March 1, 2022.
• Centers for Disease Control and Prevention. COVID-19 Mortality Overview. 2022; https://www.cdc.gov/nchs/covid19/mortality-overview.htm. Accessed March 1, 2022
• Centers for Disease Control and Prevention. COVID-19; 2022, https://www.cdc.gov/mmwr/volumes/71/wr/mm7101a4.htm#:~:text=COVID%2D19%20vaccines%20are%20highly,death%20(0.0033%25)%20were%20rare., Accessed March 1, 2022
• Humiston SG, Bennett NM, Long C, Eberly S, Arvelo L, Stankaitis J, Szilagyi PG. Increasing inner-city adult influenza vaccination rates: a randomized controlled trial. Public Health Rep. 2011 Jul-Aug;126 Suppl 2(Suppl 2):39-47. doi: 10.1177/00333549111260S206.
• Centers for Disease Control and Prevention. Immunization Strategies for Healthcare Practices and Providers. 2021; https://www.cdc.gov/vaccines/pubs/pinkbook/strat.html . Accessed April 11, 2022
• Morales-Campos DY, Flores BE, Donovan E, Burdick S, Parra-Medina D, Kahn JA. A qualitative descriptive study of providers' perspectives on human papillomavirus vaccine administration among Latino/a adolescents in South Texas clinics: barriers and facilitators. BMC Public Health. 2022 Mar 5;22(1):443. doi: 10.1186/s12889-022-12837-2.
• Shen SC, Dubey V. Addressing vaccine hesitancy: Clinical guidance for primary care physicians working with parents. Can Fam Physician. 2019 Mar;65(3):175-181.
• Mehrotra ML, Petersen ML, Geng EH. Understanding HIV Program Effects: A Structural Approach to Context Using the Transportability Framework. J Acquir Immune Defic Syndr. 2019 Dec;82 Suppl 3(Suppl 3):S199-S205. doi: 10.1097/QAI.0000000000002202.
• Pearl, J., and E. Bareinboim. External Validity: From Do-Calculus to Transportability Across Populations. Statistical Science. 2014; 29:579-595
• Dai H, Saccardo S, Han MA, Roh L, Raja N, Vangala S, Modi H, Pandya S, Sloyan M, Croymans DM. Behavioural nudges increase COVID-19 vaccinations. Nature. 2021 Sep;597(7876):404-409. doi: 10.1038/s41586-021-03843-2. Epub 2021 Aug 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: June 11, 2022
• First Submitted That Met QC Criteria: June 11, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 202204166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No