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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-08

Study Completion Date

2025-07-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Human Papilloma Virus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Gardasil 9

Intervention Type BIOLOGICAL

Prevent HPV-associated diseases and cancers

Interventions

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Gardasil 9

Prevent HPV-associated diseases and cancers

Intervention Type BIOLOGICAL

Other Intervention Names

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Human Papillomavirus Vaccine HPV vaccine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes