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Usability of HPV Vaccine Reminders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987490
Recruitment Status : Completed
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date June 17, 2019
Actual Study Start Date  ICMJE December 1, 2015
Actual Primary Completion Date August 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
Ability to utilize alternate contact methods for vaccine reminders via text messaging [ Time Frame: up to 2 weeks ]
Collection of non-deliverable text messages that were distributed to parents with children within the eligibility age.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Usability of HPV Vaccine Reminders
Official Title  ICMJE A Feasibility Trial of Parent-targeted Strategies to Increase HPV Vaccination
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Human Papilloma Virus (HPV)
Intervention  ICMJE
  • Behavioral: Text Message
    Vaccine reminder notification sent via text
  • Behavioral: PostCard
    Vaccine reminder notification sent via standard mail
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Text Message
    • Behavioral: Standard of Care
    • Behavioral: Motivational Interview
  • 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.
    Interventions:
    • Behavioral: Text Message
    • Behavioral: PostCard
    • Behavioral: Standard of Care
    • Behavioral: Motivational Interview
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2019)
286
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2016
Actual Primary Completion Date August 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987490
Other Study ID Numbers  ICMJE IRB201500997
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Staras University of Florida
PRS Account University of Florida
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP