NCT02196454

Brief Summary

The purpose of this research study is to determine if video-based education will increase HPV vaccination rates among 11 - 17 year olds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

2.4 years

First QC Date

July 16, 2014

Last Update Submit

May 31, 2018

Conditions

Keywords

HPV vaccinevaccinationimmunizationvideohealth educationcommunication

Outcome Measures

Primary Outcomes (2)

  • HPV Vaccination Series Initiation

    Number of HPV vaccine doses received among study participants

    90 days

  • HPV Vaccine Series Initiation

    HPV Vaccine Receipt among study participants

    0 days

Secondary Outcomes (2)

  • HPV Vaccine Series Initiation (depending on male versus female narrator)

    0 days

  • HPV Vaccine Series Initiation (depending on male versus female narrator)

    90 days

Other Outcomes (1)

  • HPV Vaccine Awareness

    0 days

Study Arms (2)

Vaccine Information Statement

NO INTERVENTION

Study participants will receive the HPV Vaccine Information Statement (VIS) which is part of routine care.

Video & Vaccine Information Statement

EXPERIMENTAL

Participants will view an educational video about the HPV vaccine with a male or female narrator. Participants will also receive the HPV Vaccine Information Statement (VIS) which is part of routine care.

Other: Educational Video with Male or Female Narrator

Interventions

Participants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female.

Video & Vaccine Information Statement

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent-child dyads in which the child is a male or female age 11 to 17 years who has not received the HPV vaccine

You may not qualify if:

  • Parent-child dyads in which the child has received the HPV vaccine
  • Parent-child dyads in which the child is older than 18 at the time of enrollment
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Primary Care, Flourtown, Children's Hospital of Philadelphia

Flourtown, Pennsylvania, 19031, United States

Location

Nicholas and Athena Karabots Pediatric Care Center

Philadelphia, Pennsylvania, 19139, United States

Location

MeSH Terms

Conditions

BehaviorHealth BehaviorHealth EducationCommunication

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

  • Kristen A. Feemster, MD MPH MSHP

    Children's Hospital of Philadephia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 22, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2016

Study Completion

May 31, 2018

Last Updated

June 1, 2018

Record last verified: 2018-05

Locations