PROmotion of COVID-19 BOOSTer VA(X)Ccination in the Emergency Department - PROBOOSTVAXED

NCT06156215 | Completed Results

• 2 other identifiers: 23-39854R01AI166967-01
• Study Type: interventional
• Target: 919
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this cluster randomized clinical trial is to test the efficacy of messaging interventions to increase booster vaccine uptake in adults in the emergency department(ED). The main question\[s\] and goals of this study are:

• does the intervention of vaccine messaging increase booster vaccine uptake at 30 days post ED visit?
• does the intervention of asking about vaccine acceptance increase booster vaccine uptake at 30 days post ED visit?
• considering recent national changes to funding and availability of updated vaccines, the investigators will examine the effects of these changes on vaccine acceptance and uptake in ED populations. Specifically, they will stratify EDs and ED patients according to the ED availability of vaccines, and they will also examine whether costs and availability of vaccines are a deterrent to patient acceptance and uptake of vaccines

Conditions

COVID-19

Keywords

COVID-19; health disparities; booster vaccines; healthcare access; vaccination; public health

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 30-day Booster Vaccine Uptake

  Our primary outcome is booster vaccine uptake (at any vaccination location) within 30 days after participants' index ED visit, comparing Intervention M arm with Control

  30 days

Secondary Outcomes (3)

• Number or Participants Receiving Booster Vaccination in the ED

  day of index visit

• Number of Participants Stating They Would Accept Vaccine in the ED

  on the day of index ED visit

• Number of Participants With 30-day Booster Vaccine Uptake, Q Arm

  30 days

Study Arms (3)

PROBOOSTVAXED Intervention M (Messaging + Vaccine Question)

EXPERIMENTAL

* 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.

Behavioral: Vaccine Messaging; Behavioral: Vaccine Acceptance Question

Intervention Q (Vaccine Question, No Messaging)

ACTIVE COMPARATOR

* 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.

Behavioral: Vaccine Acceptance Question

Control (No Messaging, No Vaccine Question)

NO 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.

Interventions

Vaccine Messaging BEHAVIORAL

1. Video clips - short (approximately 3-minute) Public Service Announcement type videos to be viewed by participant using a QR code on their smartphone. If no smartphone is available, the video will be shown to the participant on an iPad. 2. Printed materials - one page information sheets handed to subjects by CRCs. 3. Face to face messaging - short (\< 1 minute), scripted message from the patient's providers in the ED (nurse or provider) Each site will maintain a library of A. 5 versions of the videos - the version used in any participant will be tailored to that participant's stated race/ethnicity. B. 5 versions of printed flyers - likewise, the version will be tailored to the participant's stated race/ethnicity. C. 1 version of scripted message to be delivered in English or Spanish.

PROBOOSTVAXED Intervention M (Messaging + Vaccine Question)

Vaccine Acceptance Question BEHAVIORAL

The last question in the Vaccine Acceptance Survey in both the Intervention M and Intervention Q arms of the study is "Would you accept the COVID-19 booster vaccine in the emergency department today if your doctor asked you?"

Intervention Q (Vaccine Question, No Messaging); PROBOOSTVAXED Intervention M (Messaging + Vaccine Question)

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Presenting to ED
• No receipt of COVID-19 booster within prior 6 months
• Able to provide informed consent
• Fluent in English or Spanish
• Anticipated ability to complete study intervention in ED i.e., able to watch a 3-minute videoclip

You may not qualify if:

• Major trauma such that it will preclude survey
• Inability to participate in a survey because of intoxication, altered mental status, or critical illness
• Incarceration
• Psychiatric hold
• Patients who state that they have already received a bivalent COVID-19 booster vaccine or other COVID-19 vaccine within the prior 6 months
• Patients who are in the ED for suspected acute COVID-19

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Pfizer: collaborator
• Duke University: collaborator
• Baylor College of Medicine: collaborator
• Thomas Jefferson University: collaborator

Study Sites (7)

San Francisco General Hospital Emergency Department

San Francisco, California, 94110, United States

Location

University of California San Francisco Parnassus

San Francisco, California, 94143, United States

Location

Duke University Hospital

Durham, North Carolina, 27708, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

Location

Jefferson Methodist Hospital

Philadelphia, Pennsylvania, 19148, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Molina MF, Eucker SA, Rising KL, Kean ER, Rafique Z, Mesbah H, Glidden DV, Arreguin MI, Alvarez C, Rodriguez RM. COVID-19 Booster Vaccine Messaging in Emergency Departments: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537655. doi: 10.1001/jamanetworkopen.2025.37655.

  PMID: 41091465 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Melanie Molina
• Organization: University of California San Francisco

melanie.molina@ucsf.edu

512.294.4366

Study Officials

• Robert Rodriguez, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed at 30 days via EHR review or follow up phone call. EHR review and follow up calls will be conducted in a blinded fashion - the research staff person reviewing outcomes will be unaware of participant's study group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PROBOOSTVAXED has 3 arms: Intervention M (Messaging + Vaccine Question) * Vaccine messaging given * Vaccine acceptance question asked Intervention Q (Vaccine Question, No Messaging) * No vaccine messaging * Vaccine acceptance question asked Control (No Messaging, No Vaccine Question) * No vaccine messaging * No vaccine acceptance question

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 5, 2023
• Study Start: January 19, 2024
• Primary Completion: July 18, 2024
• Study Completion: August 18, 2024
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication of results
• Access Criteria: After review of formal request

Locations

US (7)