HPV Educational Intervention to Increase Acceptance and Completion of Free HPV Vaccination Among Underserved Adults

Human Papillomavirus Infection Clinical Trial

Official title:

Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474821
• Other study ID #: 18-010455
• Secondary ID: NCI-2020-0472318
• Status: Recruiting
• Phase: Phase 4
• Start date: October 19, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase IV trial examines the impact of an education program on the human papilloma virus (HPV) and its effects on the acceptance and completion rates of a free HPV vaccination program in underserved adult patients. Participating in the HPV educational program may increase the HPV vaccination rates among low income uninsured adult patients and ultimately prevent HPV related cancers.

Description:

PRIMARY OBJECTIVES:

I. Determine the acceptability and completion rates of free HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville, Florida.

II. Determine if an education program on HPV vaccination increases the acceptability of free HPV vaccination among the underserved adult patients at the Volunteer in Medicine Clinic (VIM) in Jacksonville, Florida.

III. Determine the baseline prevalence of HPV vaccination completion rates among VIM patients age 18-45.

IV. Determine if there are differences in acceptance and completion rates of HPV vaccination, among VIM patients of different sex, age (18-26 versus [vs] 27-45), ethnicity or race, following an education program on HPV as part of this protocol participation.

VI. Assessing possible barriers for vaccine series completion. VII. Determine if follow up intervention increases completion rate of free HPV vaccine series within 9 months.

OUTLINE:

Patients receive educational materials on HPV and are asked of their willingness to proceed with the first HPV vaccination. Patients who express interest in receiving the HPV vaccination, then receive the first dose of the HPV vaccine and the next 2 doses approximately 2 months and 6 months following the initial vaccine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male and female adults patients seen at Volunteers in Medicine ages 18-45 years of age who read and understand English or Spanish

Exclusion Criteria:

• Children (under 18 years of age)

• Individuals who had previously received any dose of HPV vaccine

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Human Papillomavirus-Related Carcinoma
• Papillomavirus Infections

Intervention

Other:
• Educational Intervention
Receive educational materials on HPV
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance and completion rates of free HPV vaccination		Up to 2 years
Secondary	Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race		Up to 2 years