TERMINATED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-08-08

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06229353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Andrzej Kulczycki, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0022

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Andrzej Kulczycki, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2024-08-08

Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

Gardasil 9
HPV

Additional Relevant MeSH Terms

Human Papilloma Virus