TerminatedNot Applicable

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

Stopped: Slow pace of recruitment

United States34 participantsStarted 2024-08-08

Plain-language 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).

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of study participants who receive HPV vaccination at baseline

Timeframe: Baseline

Number of study participants who receive HPV vaccination at 2 months

Timeframe: 2 months

Number of study participants who receive HPV vaccinations at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT06229353

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-30