Clinical trial NCT03510091: Video-Assisted Counseling for HPV Vaccination
Official title: Video-assisted Counseling for Human Papillomavirus Vaccination: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 21
Sex: ALL
Minimum age (years): 9
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: HPV vaccine initiation
timeFrame: 1 month
Secondary outcomes:
measure: Barriers to HPV vaccination
timeFrame: 1 day
measure: Visit time
timeFrame: 1 day
measure: HPV vaccine completion
timeFrame: 9 months
measure: Improvement HPV knowledge
timeFrame: 1 day
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Hospital General Pediatrics Clinic
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Michael A Ulm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Markowitz LE, Dunne EF, Saraiya M, Chesson HW, Curtis CR, Gee J, Bocchini JA Jr, Unger ER; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2014 Aug 29;63(RR-05):1-30.
citation: Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.
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