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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474821
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Human Papillomavirus-Related Carcinoma Other: Educational Intervention Other: Survey Administration Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: Educational Intervention
Receive educational materials on HPV
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Survey Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Acceptance and completion rates of free HPV vaccination [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474821


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Gerardo Colon-Otero         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gerardo Colon-Otero Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04474821    
Other Study ID Numbers: 18-010455
NCI-2020-04723 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18-010455 ( Other Identifier: Mayo Clinic in Florida )
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Papillomavirus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
Infections
DNA Virus Infections
 Virus Diseases
Tumor Virus Infections
Genital Diseases
Urogenital Diseases
Disease Attributes
Pathologic Processes