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

Purpose

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).

Condition

  • Human Papilloma Virus

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • Human Papillomavirus Vaccine
    • HPV vaccine

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact