Human Papilloma Virus
Conditions
Keywords
Gardasil 9, HPV
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).
Interventions
BIOLOGICALGardasil 9
Prevent HPV-associated diseases and cancers
Sponsors
University of Alabama at Birmingham
Merck Sharp & Dohme LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrzej Kulczycki, PhD
University of Alabama at Birmingham
Outcome results
None listed