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

NCT04474821 | Completed Phase 4

• 2 other identifiers: 18-010455NCI-2020-04723
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Infection; Human Papillomavirus-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• Acceptance and completion rates of free HPV vaccination

  Up to 2 years

Secondary Outcomes (1)

• Differences in acceptance and completion rates of HPV vaccination, among patients of different sex, ethnic or race

  Up to 2 years

Study Arms (1)

Prevention (HPV educational program)

EXPERIMENTAL

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; Other: Survey Administration

Interventions

Educational Intervention OTHER

Receive educational materials on HPV

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Prevention (HPV educational program)

Survey Administration OTHER

Ancillary studies

Prevention (HPV educational program)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female adults patients seen at Volunteers in Medicine ages 18-45 years of age who read and understand English or Spanish

You may not qualify if:

• Children (under 18 years of age)
• Individuals who had previously received any dose of HPV vaccine

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Gerardo Colon-Otero, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: October 19, 2020
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)