Usability of HPV Vaccine Reminders

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

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.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus (HPV)
• Intervention / Treatment: Behavioral: Text Message; Behavioral: Standard of Care; Behavioral: Motivational Interview; Behavioral: PostCard

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • UF Health Pediatrics - Gerold L. Schiebler CMS Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parents of Girls; Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims.	Behavioral: Text Message; Vaccine reminder notification sent via text; Behavioral: Standard of Care; No additional information given to parents; Behavioral: Motivational Interview; Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent
Experimental: Parents of Boys; Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims.	Behavioral: Text Message; Vaccine reminder notification sent via text; Behavioral: Standard of Care; No additional information given to parents; Behavioral: Motivational Interview; Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent; Behavioral: PostCard; Vaccine reminder notification sent via standard mail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients with deliverable text messages	Percentage of Patients with deliverable text messages	up to 2 weeks
Percentage of phone calls where interviewer is adherent to MI	Adherence to MI	During phone interview

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of adolescent who get one dose of the HPV vaccine	HPV vaccine initiation (1 dose)	Six months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Stephanie Staras, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: vaccine
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: IRB201500997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No