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Usability of HPV Vaccine Reminders

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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

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.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus (HPV) Behavioral: Text Message Behavioral: PostCard Behavioral: Standard of Care Behavioral: Motivational Interview Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Feasibility Trial of Parent-targeted Strategies to Increase HPV Vaccination
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : December 15, 2016

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: 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987490


Locations
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United States, Florida
UF Health Pediatrics - Gerold L. Schiebler CMS Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Stephanie Staras University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03987490     History of Changes
Other Study ID Numbers: IRB201500997
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
vaccine

Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs