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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Human Papilloma Virus

Treatments: Biological: Gardasil 9

Study type: Observational

Funder types: Other

Identifiers

NCT06229353

MISP# 101971 (Other Grant/Funding Number)

IRB-300012035

Details and patient eligibility

About

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).

Enrollment: 610 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

610 participants in 1 patient group

Under-immunized Emergency Department adult patients

Description:

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.

Treatment:

Biological: Gardasil 9