Back to resultsUsability of HPV Vaccine Reminders
Primary Purpose
Human Papilloma Virus (HPV)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message
PostCard
Standard of Care
Motivational Interview
Sponsored by
About this trial
This is an interventional prevention trial for Human Papilloma Virus (HPV) focused on measuring vaccine
Eligibility Criteria
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
Sites / Locations
- UF Health Pediatrics - Gerold L. Schiebler CMS Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Parents of Girls
Parents of Boys
Arm Description
Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims.
Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims.
Outcomes
Primary Outcome Measures
Percentage of Patients with deliverable text messages
Percentage of Patients with deliverable text messages
Percentage of phone calls where interviewer is adherent to MI
Adherence to MI
Secondary Outcome Measures
Percentage of adolescent who get one dose of the HPV vaccine
HPV vaccine initiation (1 dose)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03987490
Brief Title
Usability of HPV Vaccine Reminders
Official Title
A Feasibility Trial of Parent-targeted Strategies to Increase HPV Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
August 1, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus (HPV)
Keywords
vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parents of Girls
Arm Type
Experimental
Arm Description
Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims.
Arm Title
Parents of Boys
Arm Type
Experimental
Arm Description
Parents of 11-to-12-year-old girls who did not have records of the HPV vaccine in the EHR or Medicaid claims.
Intervention Type
Behavioral
Intervention Name(s)
Text Message
Intervention Description
Vaccine reminder notification sent via text
Intervention Type
Behavioral
Intervention Name(s)
PostCard
Intervention Description
Vaccine reminder notification sent via standard mail
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
No additional information given to parents
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview
Intervention Description
Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent
Primary Outcome Measure Information:
Title
Percentage of Patients with deliverable text messages
Description
Percentage of Patients with deliverable text messages
Time Frame
up to 2 weeks
Title
Percentage of phone calls where interviewer is adherent to MI
Description
Adherence to MI
Time Frame
During phone interview
Secondary Outcome Measure Information:
Title
Percentage of adolescent who get one dose of the HPV vaccine
Description
HPV vaccine initiation (1 dose)
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Staras
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Pediatrics - Gerold L. Schiebler CMS Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Usability of HPV Vaccine Reminders
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