Video-Assisted Counseling for HPV Vaccination
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Counseling
Intervention type(s): Behavioral
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research