A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3

Human Papilloma Virus Clinical Trial

Official title:

A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208269
• Other study ID #: IRB201200143
• Status: Completed
• Phase: N/A
• Start date: August 1, 2013
• Est. completion date: March 30, 2015

Study information

• Verified date: May 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5663
• Est. completion date: March 30, 2015
• Est. primary completion date: April 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

• Enrolled in Florida Medicaid

• Not initiated the HPV vaccine series at the start of the study period.

Exclusion Criteria:

• Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast

• Pregnant

• Not enrolled in Florida Medicaid

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma

Intervention

Other:
• postcard campaign
Post card sent to parent only
• Health Information Technology system
Accessed by adolescent and provider only

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants receiving HPV vaccine	The percent age eligible participants who initiate HPV vaccination.	Up to 5 months
Primary	Number of preventive care visits	The percent age eligible participants received a preventive care visit	Up to 3 months