Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of study participants who receive HPV vaccination at baseline
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Gardasil 9 (Biological)
Outcomes
Primary Outcomes
Number of study participants who receive HPV vaccination at baseline
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
Number of study participants receiving dose 3 of the HPV vaccination series 6 months after initial study visit
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrzej Kulczycki
Associate Professor
University of Alabama at Birmingham