Video-Assisted Counseling for HPV Vaccination

Human Papillomavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510091
• Other study ID #: VAC for HPV
• Status: Completed
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2023
• Source: Le Bonheur Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
United States	LeBonheur Children's Hospital General Pediatrics Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (11)

Brown B, Gabra MI, Pellman H. Reasons for acceptance or refusal of Human Papillomavirus Vaccine in a California pediatric practice. Papillomavirus Res. 2017 Jun;3:42-45. doi: 10.1016/j.pvr.2017.01.002. Epub 2017 Jan 17. — View Citation

Bruno DM, Wilson TE, Gany F, Aragones A. Identifying human papillomavirus vaccination practices among primary care providers of minority, low-income and immigrant patient populations. Vaccine. 2014 Jul 16;32(33):4149-54. doi: 10.1016/j.vaccine.2014.05.058. Epub 2014 Jun 2. — View Citation

Dawson R, Lemmon K, Trivedi NJ, Hansen S. Improving human papilloma virus vaccination rates throughout military treatment facilities. Vaccine. 2018 Mar 7;36(11):1361-1367. doi: 10.1016/j.vaccine.2018.02.007. Epub 2018 Feb 9. — View Citation

Donahue KL, Stupiansky NW, Alexander AB, Zimet GD. Acceptability of the human papillomavirus vaccine and reasons for non-vaccination among parents of adolescent sons. Vaccine. 2014 Jun 30;32(31):3883-5. doi: 10.1016/j.vaccine.2014.05.035. Epub 2014 May 18. — View Citation

Holman DM, Benard V, Roland KB, Watson M, Liddon N, Stokley S. Barriers to human papillomavirus vaccination among US adolescents: a systematic review of the literature. JAMA Pediatr. 2014 Jan;168(1):76-82. doi: 10.1001/jamapediatrics.2013.2752. — View Citation

Jeyarajah J, Elam-Evans LD, Stokley S, Smith PJ, Singleton JA. Human Papillomavirus Vaccination Coverage Among Girls Before 13 Years: A Birth Year Cohort Analysis of the National Immunization Survey-Teen, 2008-2013. Clin Pediatr (Phila). 2016 Sep;55(10):904-14. doi: 10.1177/0009922815616245. Epub 2015 Nov 24. — View 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. — View 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. Erratum In: MMWR Recomm Rep. 2014 Dec 12;63(49):1182. — View Citation

McRee AL, Brewer NT, Reiter PL, Gottlieb SL, Smith JS. The Carolina HPV immunization attitudes and beliefs scale (CHIAS): scale development and associations with intentions to vaccinate. Sex Transm Dis. 2010 Apr;37(4):234-9. doi: 10.1097/OLQ.0b013e3181c37e15. — View Citation

Warner EL, Ding Q, Pappas L, Bodson J, Fowler B, Mooney R, Kirchhoff AC, Kepka D. Health Care Providers' Knowledge of HPV Vaccination, Barriers, and Strategies in a State With Low HPV Vaccine Receipt: Mixed-Methods Study. JMIR Cancer. 2017 Aug 11;3(2):e12. doi: 10.2196/cancer.7345. — View Citation

Watson CH, Ulm M, Blackburn P, Smiley L, Reed M, Covington R, Bokovitz L, Tillmanns T. Video-assisted genetic counseling in patients with ovarian, fallopian and peritoneal carcinoma. Gynecol Oncol. 2016 Oct;143(1):109-112. doi: 10.1016/j.ygyno.2016.07.094. Epub 2016 Jul 12. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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