Vaccination RefusalNCT05419232

COVID-19 Vaccine Uptake Trial

A study testing Short Message Service (SMS) + Website Link Strategy and Phone Call with Peer Strategy in people with Vaccination Refusal and COVID-19, run by Washington University School of Medicine at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Vaccination Refusal, COVID-19
What is being tested?: Short Message Service (SMS) + Website Link Strategy and Phone Call with Peer Strategy
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 262 participants
Where: 8 sitesUnited States
Study dates: 15 Jul 2022to 31 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Vaccination Refusal, COVID-19
Being tested: Short Message Service (SMS) + Website Link Strategy, Phone Call with Peer Strategy
Medical subject headings: Vaccination Refusal, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Short Message Service (SMS) + Website Link StrategyOther
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 StrategyOther
The intervention we are evaluating is the effectiveness of a participant having a phone call with a peer as a vaccine uptake strategy

Study groups in NCT05419232
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Phone Call with Peer Strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 8 weeks

Secondary outcomes (1)

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.
Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202231 May 2024

First posted15 Jun 2022
Study start15 Jul 2022
Primary completion31 Dec 2023
Study completion31 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Vaccination RefusalStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05419232
Sponsor's protocol ID: 202204166
Status last verified: Jul 2026
First submitted: 11 Jun 2022
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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
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.
PubMed 33926993
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.
PubMed 21812168
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.
PubMed 35248000
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.
PubMed 30867173
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.
PubMed 31764255
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.
PubMed 34340242
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.
PubMed 25264466

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Vaccination Refusal trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RADx Up Safe Return to Schools: Strategies to Increase Vaccine Uptake
ClinicalTrials.gov ID: NCT05419232
Acronym / sponsor ID: 202204166
Conditions: Vaccination Refusal, COVID-19
Study type: Interventional
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 15 Jul 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 May 2024 (actual)
First posted: 15 Jun 2022 (actual)
Results: Posted 10 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Short Message Service (SMS) with an associated link to a multi-media website	Active comparator	Other: Short Message Service (SMS) + Website Link StrategyThe 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	Active comparator	Other: Phone Call with Peer StrategyThe 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.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Short Message Service (SMS) + Website Link StrategyThe intervention we are evaluating is the effectiveness of a participant receiving a SMS + Website Link as a vaccine uptake strategy	Other	Short Message Service (SMS) with an associated link to a multi-media website
Phone Call with Peer StrategyThe intervention we are evaluating is the effectiveness of a participant having a phone call with a peer as a vaccine uptake strategy	Other	Phone Call with Peer

Primary outcome

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.

1 secondary outcome

Vaccinated or Indicated They Would Receive Vaccine
Time frame: Up to 8 weeks

Results and safety

Results posted to the registry on 10 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Call + Call	56	53
Group 2: Call + Text	63	63
Group 3: Text + Call	52	52
Group 4: Text + Text	71	71
Group 5: Call Only	6	2
Group 6: Text Only	3	0

Primary outcome: Vaccine Uptake

Time frame: Up to 8 weeks. Count of participants. Unit: Participants

Measure	Group 1: Call + Call n = 56	Group 2: Call + Text n = 63	Group 3: Text + Call n = 52	Group 4: Text + Text n = 71	Group 5: Call Only n = 6	Group 6: Text Only n = 3
Value	1	3	1	0	2	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Call + Call	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Group 2: Call + Text	0 of 63 (0%)	0 of 63 (0%)	0 of 63
Group 3: Text + Call	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Group 4: Text + Text	0 of 71 (0%)	0 of 71 (0%)	0 of 71
Group 5: Call Only	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Group 6: Text Only	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundCenters for Disease Control and Prevention. COVID-19; 2022, https://www.cdc.gov/coronavirus/2019-ncov/index.html. Accessed March 1, 2022.
BackgroundCenters for Disease Control and Prevention. COVID-19 Mortality Overview. 2022; https://www.cdc.gov/nchs/covid19/mortality-overview.htm. Accessed March 1, 2022
BackgroundCenters 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: PubMed 33926993Milkman 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.
Background: PubMed 21812168Humiston 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.
BackgroundCenters 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: PubMed 35248000Morales-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.
Background: PubMed 30867173Shen SC, Dubey V. Addressing vaccine hesitancy: Clinical guidance for primary care physicians working with parents. Can Fam Physician. 2019 Mar;65(3):175-181.
Background: PubMed 31764255Mehrotra 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.
BackgroundPearl, J., and E. Bareinboim. External Validity: From Do-Calculus to Transportability Across Populations. Statistical Science. 2014; 29:579-595
Background: PubMed 34340242Dai 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.
Background: PubMed 25264466Almirall 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccine Uptake (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05419232, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.