Clinical trial NCT06229353: Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Official title: Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Papilloma Virus
Keywords: Gardasil 9
HPV
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-01-29
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-existing ED-patients in the waiting room who fit the eligibility criteria, as per the chart review which will indicate the participant's age, and if the participant is in good functional capacity, as determined by the ED-attending clinician, and if the participant has no known infection with HPV high risk strain types 6, 11, 16 and 18. Participants running fever or in pain at the time of the initial ED visit and still interested in receiving HPV vaccination, will be offered to come back for HPV vaccination when in good health at a later date.

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).


Eligibility 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

Primary outcomes:
measure: Number of study participants who receive HPV vaccination at baseline
timeFrame: Baseline
measure: Number of study participants who receive HPV vaccination at 2 months
timeFrame: 2 months
measure: Number of study participants who receive HPV vaccinations at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrzej Kulczycki, PhD
role: PRINCIPAL_INVESTIGATOR
References: