Usability of HPV Vaccine Reminders

Human Papilloma Virus (HPV) Clinical Trial

Official title:

A Feasibility Trial of Parent-targeted Strategies to Increase HPV Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987490
• Other study ID #: IRB201500997
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: December 15, 2016

Study information

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

Clinical Trial Summary

This study will assess the usefulness of parent-targeted strategies in improving care seeking among parents of 11-12 year old adolescents. Specifically, the study team will focus on reminders (postcard or text message) and motivational interviewing to improve adolescent vaccination.

Description:

Despite the impressive cancer preventing potential of human papillomavirus (HPV) vaccines, HPV vaccine coverage rates in the United States remain substantially lower than other vaccines and Healthy People 2020 targets. HPV vaccine initiation can be improved through targeted reminders that motivate parents. Our long-term goal is to maximize HPV vaccination rates among girls and boys within the United States using efficient and sustainable strategies. The objective of this protocol is to evaluate the usefulness of a tiered strategy of a parent-targeted strategies in improving care seeking and receptiveness to vaccine recommendations. Strategies include HPV vaccine reminders via postcard or text message and phone-based Motivational Interview sessions. The central hypothesis is addressing key health beliefs (e.g., perceived benefits and barriers) will increase parental acceptance and, thus, HPV vaccine initiation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 15, 2016
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Parents of 11-12 year olds who attend the Schiebler CMS clinic at University of Florida in the previous year

Exclusion Criteria:

• Unable to meet inclusion criteria

Related Conditions & MeSH terms

• Human Papilloma Virus (HPV)
• Papilloma

Intervention

Behavioral:
• Text Message
Vaccine reminder notification sent via text
• PostCard
Vaccine reminder notification sent via standard mail
• Standard of Care
No additional information given to parents
• Motivational Interview
Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent

Locations

Country	Name	City	State
United States	UF Health Pediatrics - Gerold L. Schiebler CMS Center	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	Percentage of Patients with deliverable text messages	Percentage of Patients with deliverable text messages	up to 2 weeks
Primary	Percentage of phone calls where interviewer is adherent to MI	Adherence to MI	During phone interview
Secondary	Percentage of adolescent who get one dose of the HPV vaccine	HPV vaccine initiation (1 dose)	Six months