HPV Educational Intervention to Increase Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients

Study Overview
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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. 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.

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

Conditions
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Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma

Intervention / Treatment
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* Other: Educational Intervention
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient of VIM clinic No history of HPV vaccination No history of allergy to HPV vaccination contents Willingness to participate in clinical trial For female patients, no history of positive HPV testing or abnormal Papanicolaou (Pap) smears Patients who read and understand English Exclusion Criteria: Individuals who had previously received the HPV vaccine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (HPV educational program)<br>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. | Other: Educational Intervention<br>* Receive educational materials on HPV<br>* Other names: Intervention, Educational;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance and completion rates of free HPV vaccination |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race |  | Up to 2 years |