Video to Promote HPV Vaccination

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Completed

CT.gov ID

NCT02196454

Collaborator

Noble Medical, LLC (Other)

110

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Acceptance Social Acceptance Acceptance Processes Health Behavior Human Papillomavirus	Other: Educational Video with Male or Female Narrator	N/A

Detailed Description

Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential to cause cancer. The vaccine is recommended because it prevents the HPV infections that most commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive the complete, three-vaccine series and have time to develop an immune response before being exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.

Results from this study will help us learn why participants do or do not get the HPV vaccination and whether video-based education can help improve vaccination rates

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Educating Pre/Teens and Their Parents on the Importance of HPV Vaccination

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Vaccine Information Statement Study participants will receive the HPV Vaccine Information Statement (VIS) which is part of routine care.
Experimental: Video & Vaccine Information Statement 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 Participants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female.

Arm

Intervention/Treatment

No Intervention: Vaccine Information Statement

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

Experimental: Video & Vaccine Information Statement

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

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

Outcome Measures

Primary Outcome Measures

HPV Vaccination Series Initiation [90 days]
Number of HPV vaccine doses received among study participants
HPV Vaccine Series Initiation [0 days]
HPV Vaccine Receipt among study participants

Secondary Outcome Measures

HPV Vaccine Series Initiation (depending on male versus female narrator) [0 days]
Difference in rate of HPV vaccine receipt between study participants who viewed a video narrated by a male versus a female
HPV Vaccine Series Initiation (depending on male versus female narrator) [90 days]
Difference in number of HPV vaccine doses between study participants who viewed a video narrated by a male versus a female

Other Outcome Measures

HPV Vaccine Awareness [0 days]
Reported reason for HPV vaccine receipt or deferral

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Care, Flourtown, Children's Hospital of Philadelphia	Flourtown	Pennsylvania	United States	19031
2	Nicholas and Athena Karabots Pediatric Care Center	Philadelphia	Pennsylvania	United States	19139