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

NCT06229353 | Terminated FDA Drug

• 2 other identifiers: IRB-300012035MISP# 101971
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Human Papilloma Virus

Keywords

Gardasil 9; HPV

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (1)

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

Interventions

Gardasil 9 BIOLOGICAL

Prevent HPV-associated diseases and cancers

Also known as: Human Papillomavirus Vaccine, HPV vaccine

Under-immunized Emergency Department adult patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0022, United States

Location

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent; Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Andrzej Kulczycki, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 29, 2024
• Study Start: August 8, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Article 9, or eighteen (18) months following completion of the Study or termination of this Agreement, whichever occurs first.

Locations

US (1)