NCT03510091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

April 16, 2018

Last Update Submit

December 11, 2023

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

  • HPV vaccine initiation

    Percentage of adolescents enrolled initiating HPV vaccination

    1 month

Secondary Outcomes (4)

  • Barriers to HPV vaccination

    1 day

  • Visit time

    1 day

  • HPV vaccine completion

    9 months

  • Improvement HPV knowledge

    1 day

Study Arms (1)

Video-Assisted Counseling

EXPERIMENTAL

Patients receiving video-assisted counseling

Behavioral: Counseling

Interventions

CounselingBEHAVIORAL

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

Video-Assisted Counseling

Eligibility Criteria

Age9 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Hypersensitivity to yeast
  • Hypersensitivity to prior HPV vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LeBonheur Children's Hospital General Pediatrics Clinic

Memphis, Tennessee, 38103, United States

Location

Related Publications (11)

  • 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.

    PMID: 25167164BACKGROUND

  • 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.

    PMID: 25693011BACKGROUND

  • 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.

    PMID: 26603581BACKGROUND

  • 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.

    PMID: 28801303BACKGROUND

  • 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.

    PMID: 24886959BACKGROUND

  • 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.

    PMID: 24276343BACKGROUND

  • 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.

    PMID: 28720455BACKGROUND

  • 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.

    PMID: 24844150BACKGROUND

  • 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.

    PMID: 27416795BACKGROUND

  • 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.

    PMID: 19940807BACKGROUND

  • 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.

    PMID: 29433899BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Counseling

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Michael A Ulm, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 27, 2018

Study Start

August 30, 2018

Primary Completion

November 30, 2018

Study Completion

June 30, 2019

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

US(1)