Usability of HPV Vaccine Reminders

NCT ID: NCT03987490

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2016-12-15

Brief Summary

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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

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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.

Conditions

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Human Papilloma Virus (HPV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Text Message

Intervention Type BEHAVIORAL

Vaccine reminder notification sent via text

Standard of Care

Intervention Type BEHAVIORAL

No additional information given to parents

Motivational Interview

Intervention Type BEHAVIORAL

Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent

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.

Group Type EXPERIMENTAL

Text Message

Intervention Type BEHAVIORAL

Vaccine reminder notification sent via text

PostCard

Intervention Type BEHAVIORAL

Vaccine reminder notification sent via standard mail

Standard of Care

Intervention Type BEHAVIORAL

No additional information given to parents

Motivational Interview

Intervention Type BEHAVIORAL

Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent

Interventions

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Text Message

Vaccine reminder notification sent via text

Intervention Type BEHAVIORAL

PostCard

Vaccine reminder notification sent via standard mail

Intervention Type BEHAVIORAL

Standard of Care

No additional information given to parents

Intervention Type BEHAVIORAL

Motivational Interview

Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parents of 11-12 year olds who attend the Schiebler CMS clinic at University of Florida in the previous year
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Staras

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health Pediatrics - Gerold L. Schiebler CMS Center

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201500997

Identifier Type: -

Identifier Source: org_study_id

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