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

Recruiting

• Conditions: Human Papilloma Virus
• Interventions: Biological: Gardasil 9

• Registration Number: NCT06229353
• Lead Sponsor: University of Alabama at Birmingham

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-01-29
• Study Start: 2024-08-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 610

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Under-immunized Emergency Department adult patients	Gardasil 9	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States