Effectiveness of Targeted Educational Interventions at Increasing HPV Vaccine Acceptability and Uptake

April 9, 2018 updated by: University of Pennsylvania
This study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be reviewed to assess for initiation of the HPV vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

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
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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

12 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Females ages greater than or equal to 12 years and less than or equal to 26 years
  2. Presenting to a gynecology clinic for a routine or problem visit
  3. Ability to read and write

Exclusion Criteria:

  1. Women ages less than or greater than 12 years or greater than 26 years
  2. Women with known cervical cancer
  3. Known pregnancy
  4. Prior initiation or completion of the HPV vaccine series

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Subject does not receive an educational intervention
Other: Control
Control
Other: Educational video
Subject watches an educational video
Other: Educational video
Approximately 7 minute video on the HPV vaccine
Other: Educational handout
Subject reads an educational handout
Other: Educational handout
One page handout on the HPV vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV vaccine acceptability
Time Frame: Up to 6 months
Subject reported willingness to accept the HPV vaccination, as assessed through agreement or disagreement to the statement "I would be willing to accept the HPV vaccine today."
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV vaccine knowledge
Time Frame: Up to 6 months
Subject knowledge of the HPV vaccine and its associated risks and benefits, as assessed through a survey. Subjects are asked to answer 7 questions and total knowledge score is calculated by an unweighted sum of correct answers.
Up to 6 months

Collaborators and Investigators

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

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2017

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 826486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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