HPV Educational Intervention to Increase Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients
Primary Purpose
Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Survey Administration
Sponsored by
About this trial
This is an interventional health services research trial for Human Papillomavirus Infection
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prevention (HPV educational program)
Arm Description
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.
Outcomes
Primary Outcome Measures
Acceptance and completion rates of free HPV vaccination
Secondary Outcome Measures
Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04474821
Brief Title
HPV Educational Intervention to Increase Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients
Official Title
Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prevention (HPV educational program)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive educational materials on HPV
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Acceptance and completion rates of free HPV vaccination
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo Colon-Otero
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Gerardo Colon-Otero
12. IPD Sharing Statement
Learn more about this trial
HPV Educational Intervention to Increase Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients
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