COVID-19 Vaccine Uptake Trial

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05419232
• Other study ID #: 202204166
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6100
• Est. completion date: May 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Vaccination Refusal

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Ferguson-Florissant School District	Hazelwood	Missouri
United States	Jennings School District	Jennings	Missouri
United States	Pattonville School District	Saint Ann	Missouri
United States	Maplewood Richmond Heights School District	Saint Louis	Missouri
United States	Normandy Schools Collaborative	Saint Louis	Missouri
United States	Ritenour School District	Saint Louis	Missouri
United States	St. Louis Language Immersion School	Saint Louis	Missouri
United States	University City School District	University City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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/coronavirus/2019-ncov/index.html. 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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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