Clinical trial NCT04474821: HPV Educational Intervention to Increase Acceptance and Completion of Free HPV Vaccination Among Underserved Adults
Official title: Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Human Papillomavirus Infection
Human Papillomavirus-Related Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptance and completion rates of free HPV vaccination
timeFrame: Up to 2 years
Secondary outcomes:
measure: Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Gerardo Colon-Otero, M.D.
role: PRINCIPAL_INVESTIGATOR
References: