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

Phase 4

Recruiting

• Conditions: Human Papillomavirus Infection; Human Papillomavirus-Related Carcinoma
• Interventions: Other: Educational Intervention; Other: Survey Administration

• Registration Number: NCT04474821
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-17
• Study Start: 2020-10-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

• Children (under 18 years of age)
• Individuals who had previously received any dose of HPV vaccine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (HPV educational program)	Educational Intervention	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.
Prevention (HPV educational program)	Survey Administration	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.

Primary Outcome Measures

Name	Time	Method
Acceptance and completion rates of free HPV vaccination	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race	Up to 2 years

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States