Video-Assisted Counseling for HPV Vaccination

December 11, 2023 updated by: Michael Ulm, Le Bonheur Children's Hospital

Video-assisted Counseling for Human Papillomavirus Vaccination: A Pilot Study

Video-assisted counseling has been shown to improve consistency of counseling regarding a wide variety of health-care related issues. West Cancer Center has shown a significant increase in breast cancer susceptibility gene testing in ovarian cancer patients following video-assisted counseling compared to traditional provider-led counseling. This trial is designed to determine if video-assisted counseling can improve HPV vaccination rates by providing consistent counseling in a timely fashion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Purpose

    To increase human papillomavirus (HPV) vaccination series initiation and completion in an outpatient pediatric clinic as well as to assess attitudinal and logistic barriers to HPV vaccination.

  2. Rationale

    HPV is the most common sexually transmitted infection and is implicated in the development of oropharyngeal and anogenital cancers. Currently three vaccinations against HPV are available: a bivalent vaccine (HPV types 16 and 18), quadrivalent vaccine (HPV types 6, 11, 16, 18), and 9-valent vaccine (HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58). The 9-valent vaccine vaccinates against HPV types that cause approximately 90% of cervical cancers, anal cancers, anogenital warts and a significant proportion of oropharyngeal, vulvar, vaginal and penile cancers.

    Although HPV vaccination has been proven to significantly decrease the incidence of anogenital dysplasia, widespread acceptance among patients and providers has been difficult to achieve. The 2015 National Immunization Survey-Teen data found for females and males ages 13-17, 63 and 50 percent received ≥1 dose and 42 and 28 percent received all three doses respectively. Multiple studies have identified barriers to HPV vaccination including attitudes toward HPV, lack of provider recommendation or appropriate counseling, lack of provider knowledge, paucity of preventative care visits and inadequate time for appropriate counseling. HPV vaccination is especially difficult in an urban practice setting given racial and socioeconomic discrepancies in patient understanding of HPV vaccination and unique barriers to vaccination series completion. Regardless of race or socioeconomic background, however, >95% of parents trust their doctor's advice on HPV vaccination, highlighting the need for consistent and clear counseling among all providers caring for patients ages 9-26.

    The West Cancer Center in Memphis, TN recently published data on video-assisted genetic counseling in patients with ovarian, fallopian tube and primary peritoneal cancer. In eligible patients, a 7 minute counseling video increased the rate of breast cancer susceptibility gene testing by 25% compared to traditional, provider-led counseling. Given these results we sought to apply the concept of video-assisted counseling to HPV vaccination in the pediatric population.

  3. Study/Project Population

    Parents of children ages 9-18 as well as children ages 9-18 years who have not previously completed the HPV vaccination series will be eligible for enrollment during outpatient care visits at Le Bonheur Children's Hospital in Memphis, Tennessee. Children who are pregnant, have a hypersensitivity to yeast, or have experienced hypersensitivity to a prior HPV vaccination will be considered ineligible.

  4. Research Design

    Single arm prospective trial.

  5. Study/Project Procedures

    Procedures

    After informed consent is obtained from a parent or legal guardian, eligible patients and their parents or legal guardians will be shown a condensed, standardized counseling video on a tablet during their initial appointment after enrollment. The video will be approximately 3 minutes long and review HPV transmission, relation to cancer, role of immunization, myths, side effects, series timing and need for completion. All parents or legal guardians of patients will be given the option to proceed with HPV vaccination, decline, or discuss further with their provider. Providers will confirm the option chosen by the parents or legal guardians at the initial visit, as parental consent is required at Le Bonheur Children's Hospital for HPV vaccination. A modified Carolina HPV Immunization Attitudes and Beliefs Scale will be administered to both the parent or legal guardian prior to and following video-assisted counseling. All parents will be given a handout reviewing recommendations for HPV vaccination after the video is complete. Electronic medical record (EMR) review will be performed for pertinent medical and demographic data. Data collected will be compared to HPV vaccination outcomes from 1/1/2015 to 12/31/2015, when standardized, provider-led counseling using a pre-written template was performed.

    Statistical Analysis

    A minimum of 30 patients will be enrolled to determine a stable rate of HPV vaccination initiation and completion in this patient population with a target of 70 patients to assess for a 10% difference in HPV vaccination initiation from a historical baseline of 62% during outpatient care visits at Le Bonheur Children's Hospital when standardized, provider-led counseling using a prewritten template was performed. Faculty in the Department of Epidemiology at the University of Memphis will perform statistical analysis. Faculty in the Department of Preventive Medicine at the University of Tennessee Health Science Center will perform geographic information system analysis.

  6. Outcome measures

Aim 1: To examine the feasibility and efficacy of a video-based educational intervention to increase: 1) the percentage of adolescent patients initiating the HPV vaccination series and 2) the percentage of adolescent patients completing the HPV vaccination series.

Aim 2: To examine the relationships between demographic factors, attitudinal barriers to HPV vaccination among parents, visit time, individual provider characteristics, time spent with a provider, and HPV vaccination initiation and completion.

Study Type

Interventional

Enrollment (Actual)

21

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
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • LeBonheur Children's Hospital General Pediatrics Clinic

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

9 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Males and females ages 9-18 years who have not completed the HPV vaccination series

and

Parents or legal guardians of children ages 9-18 who have not completed the HPV vaccination series who are enrolled in the study

Exclusion Criteria:

  1. Pregnancy
  2. Hypersensitivity to yeast
  3. Hypersensitivity to prior HPV vaccination

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video-Assisted Counseling
Patients receiving video-assisted counseling
Behavioral: Counseling
A video will be shown to parents of patients ages 9-18 that review HPV transmission, relation to cancer, role of immunization, myths, side effects, series timing and need for completion. All parents or legal guardians of patients will be given the option to proceed with HPV vaccination, decline, or discuss further with their provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV vaccine initiation
Time Frame: 1 month
Percentage of adolescents enrolled initiating HPV vaccination
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers to HPV vaccination
Time Frame: 1 day
Attitudinal, educational and socioeconomic demographics contributing to failure to HPV vaccination series derived from parental questionnaire
1 day
Visit time
Time Frame: 1 day
Time in minutes of patient visit (from rooming to patient discharge)
1 day
HPV vaccine completion
Time Frame: 9 months
Percentage of adolescents completing HPV vaccination series (2 total for 9-14, 3 total for 15-18)
9 months
Improvement HPV knowledge
Time Frame: 1 day
Difference in number of correct responses regarding HPV-related cancers and HPV vaccination on pre-intervention and post-intervention questionnaires
1 day

Collaborators and Investigators

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

Sponsor

Le Bonheur Children's Hospital

Investigators

  • Principal Investigator: Michael A Ulm, MD, University of Tennessee

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)

August 30, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAC for HPV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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