Improving HPV vaccination in emergency departments for high-risk adults
Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
University of Alabama at Birmingham · NCT06229353
This study tests a new way to give the HPV vaccine to adults aged 18 to 45 in emergency departments to see if it helps more people get vaccinated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 610 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06229353 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a novel approach to increase HPV vaccination coverage among adults aged 18 to 45 who are under-immunized. It will develop and pilot an HPV vaccination protocol specifically in the emergency department (ED) setting, targeting two age groups: 18-26 and 27-45 years old. The study will assess whether the ED can serve as a viable location for administering the Gardasil 9 vaccine to eligible patients who have not completed their vaccination series. The approach will be evaluated for its feasibility and impact on vaccination rates.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-45 who have not received the HPV vaccine or have not completed the vaccine series.
Not a fit: Patients who are under 18 or over 45 years old, or those with known HPV infections or abnormal HPV test results, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase HPV vaccination rates among high-risk adults, reducing the incidence of HPV-related diseases.
How similar studies have performed: Other studies have shown success in utilizing emergency department settings for vaccination programs, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Andrzej Kulczycki, PhD — University of Alabama at Birmingham
- Study coordinator: Andrzej Kulczycki, PhD
- Email: andrzej@uab.edu
- Phone: 2059349875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Human Papilloma Virus, Gardasil 9, HPV