COVID-19 Vaccine Uptake Trial

NCT05419232 | Completed Results

• 1 other identifier: 202204166
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 8

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.

Conditions

Vaccination Refusal; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vaccinated or Indicated They Would Receive Vaccine

  Up to 8 weeks

Study Arms (2)

Short Message Service (SMS) with an associated link to a multi-media website

ACTIVE COMPARATOR

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

Phone Call with Peer

ACTIVE COMPARATOR

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

Interventions

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

Short Message Service (SMS) with an associated link to a multi-media website

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

Phone Call with Peer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (8)

Ferguson-Florissant School District

Hazelwood, Missouri, 63042, United States

Location

Jennings School District

Jennings, Missouri, 63136, United States

Location

Pattonville School District

Saint Ann, Missouri, 63074, United States

Location

St. Louis Language Immersion School

St Louis, Missouri, 63103, United States

Location

Ritenour School District

St Louis, Missouri, 63114, United States

Location

Normandy Schools Collaborative

St Louis, Missouri, 63121, United States

Location

Maplewood Richmond Heights School District

St Louis, Missouri, 63144, United States

Location

University City School District

University City, Missouri, 63130, United States

Location

Related Publications (12)

• Centers for Disease Control and Prevention. COVID-19; 2022, https://www.cdc.gov/coronavirus/2019-ncov/index.html. Accessed March 1, 2022.

  BACKGROUND

• Centers for Disease Control and Prevention. COVID-19 Mortality Overview. 2022; https://www.cdc.gov/nchs/covid19/mortality-overview.htm. Accessed March 1, 2022

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33926993 BACKGROUND

• 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.

  PMID: 21812168 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35248000 BACKGROUND

• 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.

  PMID: 30867173 BACKGROUND

• 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.

  PMID: 31764255 BACKGROUND

• Pearl, J., and E. Bareinboim. External Validity: From Do-Calculus to Transportability Across Populations. Statistical Science. 2014; 29:579-595

  BACKGROUND

• 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.

  PMID: 34340242 BACKGROUND

• 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.

  PMID: 25264466 BACKGROUND

MeSH Terms

Conditions

Vaccination Refusal; COVID-19

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Jason Newland
• Organization: Nationwide Children's Hospital

jason.newland@nationwidechildrens.org

6147223416

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 15, 2022
• Study Start: July 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)