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Human Papillomavirus Education Programs

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04880837
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
20.1
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial aims to implement a culturally-tailored educational outreach actives with the goal of increasing knowledge of human papillomavirus (HPV) types that can lead to cancer and uptake of the available vaccine. The initiative also addresses barriers to vaccination and refer people to sites where they can get the HPV vaccine (e.g., private doctor offices, community health clinics, school-based health centers, and health departments). The HPV education program may help increase HPV vaccination rates and ultimately prevent HPV-related cancers.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Informational Intervention
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To implement culturally tailored educational outreach activities with the goal of increasing knowledge of HPV types that can lead to cancer and uptake of the available vaccine.
OUTLINE:

Participants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. Participants participate in surveys over telephone or face-to-face at 3 and 6 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Human Papillomavirus Education Programs
Actual Study Start Date :
Apr 27, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prevention (educational session, handout, survey)

Participants attend educational session about HPV-related cancers, screening, and HPV vaccination and guidelines and receive informational infographic handout on HPV vaccination. Participants also complete surveys pre and post education session over 5 minutes each to assess HPV vaccination status among children of participants, HPV knowledge, and intentions to get the HPV vaccination, and screening among participants. In addition, participants complete surveys over telephone or face-to-face at 3 and 6 months.

Other: Educational Intervention
Attend educational session
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

    • Other: Informational Intervention
    Receive handouts

    Other: Survey Administration
    Complete surveys

    Outcome Measures

    Primary Outcome Measures

    1. Change in human papillomavirus (HPV) knowledge [Baseline up to 6 months]

      Change in knowledge and strength of intention to be vaccinated will be correlated with key outcomes, specifically actual vaccination and actions promoting vaccination (e.g., encouraging HPV vaccination with family/friends, talking to their doctor/provider about the HPV vaccine). Multivariable logistic regression analyses will be conducted to examine the impact of knowledge change and strength of intentions on these binary outcomes (vaccinated/not vaccinated and encouraged/did not encourage HPV vaccination) controlling for important covariates such as age, sex, race/ethnicity, education, primary language, and health insurance/health care coverage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 years of age and older

    • From Ohio

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Electra D Paskett, PhD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04880837
    Other Study ID Numbers:
    • OSU-20370
    • NCI-2021-00730
    First Posted:
    May 11, 2021
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No

    Study Results

    No Results Posted as of May 13, 2022