NCT04880837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

May 6, 2021

Last Update Submit

October 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in human papillomavirus (HPV) knowledge

    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.

    Baseline up to 6 months

Study Arms (1)

Prevention (educational session, handout, survey)

EXPERIMENTAL

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 InterventionOther: Informational InterventionOther: Survey Administration

Interventions

Attend educational session

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Prevention (educational session, handout, survey)

Receive handouts

Prevention (educational session, handout, survey)

Complete surveys

Prevention (educational session, handout, survey)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • From Ohio

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Interventions

Early Intervention, EducationalEducational StatusMethods

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Electra D Paskett, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 11, 2021

Study Start

April 27, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations