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

NCT ID: NCT04474821

Last Updated: 2026-01-12

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2025-12-22

Brief Summary

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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

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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.

Conditions

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Human Papillomavirus Infection Human Papillomavirus-Related Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Prevention (HPV educational program)

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive educational materials on HPV

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Receive educational materials on HPV

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerardo Colon-Otero, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2020-04723

Identifier Type: REGISTRY

Identifier Source: secondary_id

18-010455

Identifier Type: OTHER

Identifier Source: secondary_id

18-010455

Identifier Type: -

Identifier Source: org_study_id

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