Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department

To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. This study will develop, pilot and evaluate an ED-based HPV vaccination protocol and program for ED patients aged 18-26 (for whom catch-up HPV vaccination is routinely recommended by the CDC) and separately for patients aged 27-45 (for whom it may be recommended under shared decision making, SDM).

Study Overview

• Status: Terminated
• Conditions: Human Papilloma Virus
• Intervention / Treatment: Biological: Gardasil 9

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0022
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pre-existing ED-patients in the waiting room who fit the eligibility criteria, as per the chart review which will indicate the participant's age, and if the participant is in good functional capacity, as determined by the ED-attending clinician, and if the participant has no known infection with HPV high risk strain types 6, 11, 16 and 18. Participants running fever or in pain at the time of the initial ED visit and still interested in receiving HPV vaccination, will be offered to come back for HPV vaccination when in good health at a later date.

Description

Inclusion Criteria:

• aged 18-45 years old
• in good functional capacity, as determined by the ED-attending clinician
• no known infection with HPV high risk strain types 6, 11, 16 and 18.

Exclusion Criteria:

• will not receive vaccine if participants lack mental clarity and if running a fever or in some pain.
• Patients aged <18 or > 45 years of age.
• Female patients with abnormal HPV results (including those with the high-risk HPV strain types 6, 11, 16, and 18) as determined by a previous PAP smear test or HPV test.
• Female patients who are known to be pregnant.
• Male patients with known cases of HPV-associated infections will also be excluded from the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Under-immunized Emergency Department adult patients; Adults attending the Emergency Department who are aged 18-45, without previous HPV vaccination history and without previously known infection from HPV high-risk strain, and in good functional capacity. Eligible participants will receive Gardasil 9 (HPV) vaccination if interested.	Biological: Gardasil 9; Prevent HPV-associated diseases and cancers; Other Names: HPV vaccine; Human Papillomavirus Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of study participants who receive HPV vaccination at 2 months	Number of study participants receiving dose 2 of the HPV vaccination series 2 months after initial study visit	2 months
Number of study participants who receive HPV vaccinations at 6 months	Number of study participants receiving dose 3 of the HPV vaccination series 6 months after initial study visit	6 months
Number of study participants who receive HPV vaccination at baseline	HPV vaccination will be administered at the time of the study participant's initial visit (baseline)	Baseline

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Andrzej Kulczycki, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HPV; Gardasil 9
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Human Papillomavirus Recombinant Vaccine nonavalent; Papillomavirus Vaccines
• Other Study ID Numbers: IRB-300012035; MISP# 101971 (Other Grant/Funding Number: Merck Investigator Studies Program (MISP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Study data and results will be owned by the University of Alabama at Birmingham (UAB). UAB agrees that all Study data and results generated during the course of the Study may be used fully by Merck for any legitimate business purpose without any additional payments being made to UAB or the PI. Merck agrees not to publish the research data and results generated during the Study until the PI's publication or presentation of the Study results in accordance with Article 9, or 18 months following study completion or termination of this Agreement, whichever occurs first. Merck may disclose the research data and results to health authorities if such disclosure is prior to publication. Merck shall use reasonable efforts to disclose such research data and results confidentially. UAB agrees not to provide any commercial third party with access to or with the right to use the unpublished data or results for any purpose without Merck's permission which shall not be unreasonably withheld.
• IPD Sharing Time Frame: Article 9, or eighteen (18) months following completion of the Study or termination of this Agreement, whichever occurs first.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No