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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

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294-0022
Contact:
Whitney Covington, MPH, MLS, (ASCP)CM
2059964791
wcovington@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Andrzej Kulczycki, PhD
2059349875
andrzej@uab.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.