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

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229353
• Other study ID #: IRB-300012035
• Secondary ID: MISP# 101971
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Andrzej Kulczycki, PhD
• Phone: 2059349875
• Email: andrzej[@]uab.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 610
• Est. completion date: August 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Human Papilloma Virus
• Papilloma

Intervention

Biological:
• Gardasil 9
Prevent HPV-associated diseases and cancers

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Merck Investigator Studies Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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