NCT03987490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

June 11, 2019

Last Update Submit

May 15, 2020

Conditions

Keywords

vaccine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Percentage of adolescent who get one dose of the HPV vaccine

    Six months

Study Arms (2)

Parents of Girls

EXPERIMENTAL

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 MessageBehavioral: Standard of CareBehavioral: Motivational Interview

Parents of Boys

EXPERIMENTAL

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 MessageBehavioral: PostCardBehavioral: Standard of CareBehavioral: Motivational Interview

Interventions

Text MessageBEHAVIORAL

Vaccine reminder notification sent via text

Parents of BoysParents of Girls
PostCardBEHAVIORAL

Vaccine reminder notification sent via standard mail

Parents of Boys

No additional information given to parents

Parents of BoysParents of Girls

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

Parents of BoysParents of Girls

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of 11-12 year olds who attend the Schiebler CMS clinic at University of Florida in the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health Pediatrics - Gerold L. Schiebler CMS Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Interventions

Standard of CareMotivational Interviewing

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stephanie Staras

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 17, 2019

Study Start

December 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 15, 2016

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations