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Vaccine Promotion Strategies for COVID-19 (PROBOOSTVAXED Trial)

N/A

Recruiting

Led By Robert Rodriguez, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

PROBOOSTVAXED Trial Summary

This trial aims to see if messaging and/or asking about vaccine acceptance increases adults' booster vaccine uptake at 30 days post ED visit.

Who is the study for?

This trial is for adults over 18 who haven't had a COVID-19 booster in the last 6 months, can consent, speak English or Spanish, and are visiting the emergency department. They must be able to watch a short video. People with major trauma, intoxication, critical illness, incarceration, psychiatric hold or recent vaccination are excluded.Check my eligibility

What is being tested?

The study tests if certain messages about COVID-19 boosters increase how many people get vaccinated after an ED visit. Some will just answer questions on vaccines; others also get extra info on benefits of boosters. The effect of these strategies on vaccine uptake at 30 days post-visit is compared.See study design

What are the potential side effects?

Since this trial focuses on messaging rather than administering vaccines directly, there aren't direct side effects from the intervention itself. However, general side effects of COVID-19 vaccines include sore arm, tiredness, headache and fever.

PROBOOSTVAXED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

PROBOOSTVAXED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on the day of index ed visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on the day of index ed visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and on the day of index ed visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

30-day booster vaccine uptake

Secondary outcome measures

30-day booster vaccine uptake, Q arm

Booster vaccination in the ED

Vaccine acceptance in the ED

PROBOOSTVAXED Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PROBOOSTVAXED Intervention M (Messaging + Vaccine Question)Experimental Treatment2 Interventions

Vaccine messaging Vaccine acceptance question All patients will receive an Intake Survey assessing their demographic and vaccination information. At the end of the Intake Survey, the Clinical Research Coordinator (CRC) will deliver the booster vaccine information flyer and ask the patient if they will watch a short video on booster vaccines. If they agree, the CRC will give them a QR code to view the video on their smartphone or an iPad. After finishing with the video, the CRC will tell the subject that they will be back for the Vaccine Acceptance survey. The CRC will then leave the room and ask the patient's primary provider to deliver the booster vaccine scripted message. This message is short and should not significantly impact provider workflow. Vaccine Acceptance Survey (Post-Intervention) in the ED: We will administer the Vaccine Acceptance Survey at 30 minutes to 3 hours after the Intake Survey.

Group II: Intervention Q (Vaccine Question, No Messaging)Active Control1 Intervention

No vaccine messaging Vaccine acceptance question asked in the Vaccine Acceptance Survey Vaccine Acceptance Survey: We will administer the Vaccine Acceptance Survey at some time (generally 30 minutes but up to 3 hours) after the Intake Survey. The surveys in the control group retain the same key primary and secondary outcome questions as in the intervention group Vaccine Acceptance surveys.

Group III: Control (No Messaging, No Vaccine Question)Active Control1 Intervention

No vaccine messaging No vaccine acceptance question The workflow during this arm is identical to the Intervention Q arm except there will be no Vaccine Acceptance Question survey.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,419,772 Total Patients Enrolled

50 Trials studying COVID-19

355,419 Patients Enrolled for COVID-19

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,282 Total Patients Enrolled

67 Trials studying COVID-19

1,436,439 Patients Enrolled for COVID-19

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

6,001,468 Total Patients Enrolled

9 Trials studying COVID-19

1,058 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many sites is this trial administrated?

"The San Francisco General Hospital Emergency Department in Durham, North carolina; Duke University Hospital in Philadelphia, Pennsylvania; and Thomas Jefferson University Hospital in Houston, Texas are all participating sites for this trial. Additionally there are 7 other enrolment locations scattered across the nation."

Answered by AI

Are there still openings available for participants in this experiment?

"As per clinicaltrials.gov, this research endeavour is not actively recruiting participants at present time. Initially posted on January 1st of 2024 and most recently updated in December of 2023, the study has yet to begin enrollment; however, 852 other trials are currently seeking volunteers."

Answered by AI