Video to Promote HPV Vaccination

May 31, 2018 updated by: Children's Hospital of Philadelphia

Educating Pre/Teens and Their Parents on the Importance of HPV Vaccination

The purpose of this research study is to determine if video-based education will increase HPV vaccination rates among 11 - 17 year olds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential to cause cancer. The vaccine is recommended because it prevents the HPV infections that most commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive the complete, three-vaccine series and have time to develop an immune response before being exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.

Results from this study will help us learn why participants do or do not get the HPV vaccination and whether video-based education can help improve vaccination rates

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Flourtown, Pennsylvania, United States, 19031
        • Primary Care, Flourtown, Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19139
        • Nicholas and Athena Karabots Pediatric Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parent-child dyads in which the child is a male or female age 11 to 17 years who has not received the HPV vaccine

Exclusion Criteria:

  • Parent-child dyads in which the child has received the HPV vaccine
  • Parent-child dyads in which the child is older than 18 at the time of enrollment
  • Non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Vaccine Information Statement
Study participants will receive the HPV Vaccine Information Statement (VIS) which is part of routine care.
Experimental: Video & Vaccine Information Statement
Participants will view an educational video about the HPV vaccine with a male or female narrator. Participants will also receive the HPV Vaccine Information Statement (VIS) which is part of routine care.
Other: Educational Video with Male or Female Narrator
Participants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV Vaccination Series Initiation
Time Frame: 90 days
Number of HPV vaccine doses received among study participants
90 days
HPV Vaccine Series Initiation
Time Frame: 0 days
HPV Vaccine Receipt among study participants
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV Vaccine Series Initiation (depending on male versus female narrator)
Time Frame: 0 days
Difference in rate of HPV vaccine receipt between study participants who viewed a video narrated by a male versus a female
0 days
HPV Vaccine Series Initiation (depending on male versus female narrator)
Time Frame: 90 days
Difference in number of HPV vaccine doses between study participants who viewed a video narrated by a male versus a female
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV Vaccine Awareness
Time Frame: 0 days
Reported reason for HPV vaccine receipt or deferral
0 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Noble Medical, LLC

Investigators

  • Principal Investigator: Kristen A. Feemster, MD MPH MSHP, Children's Hospital of Philadephia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 14-011091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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