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PreTeenVax Evaluation

NCT03186430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2018-08-08

No results posted yet for this study

Summary

The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion toolkit implemented in the pediatric healthcare setting on increasing the likelihood that adolescents in Georgia will initiate and complete the Human Papillomavirus (HPV) vaccine series. Secondary research aims include assessing the impact of the comprehensive toolkit on 1) patient and parent knowledge and attitudes regarding HPV vaccine, and 2) provider recommendation of HPV vaccine for males and females in the recommended age range (11-12 years). The intervention toolkit will include evidence-based components aimed at the practice-level, provider-level and parent-level that will be tested through a cluster-randomized trial design. The primary hypothesis is that implementation of the comprehensive vaccine promotion toolkit in the pediatric health care setting will increase the likelihood that an adolescent receives initiates HPV vaccination.

At the initial visit, parents of adolescent patients at participating pediatric practices will complete a brief questionnaire assessing their knowledge, attitudes, and beliefs about adolescent health, including protection against infectious diseases during adolescence. The parents will be contacted again three months later to complete a short follow-up interview on the general health of their adolescent child, immunization status, and attitudes regarding vaccination.

Conditions

Interventions

BEHAVIORAL

Comprehensive Vaccine Promotion Package

Practice-level components: Periodic feedback on adolescent immunization coverage. Assistance with implementing and utilizing standing orders for adolescent vaccine administration in the practice, utilizing standardized materials as provided by the Centers for Disease Control and Prevention and the Immunization Action Coalition. Identification of an immunization champion to facilitate immunization activities in the practice. Linkage to peer-to-peer training on adolescent vaccination through the Georgia Educating Providers In their Communities (EPIC) program. Provider-level components: Providers will receive standardized talking points, vaccine promotion scripts and answers to frequently asked questions, with training on how best to discuss, recommend and answer questions about vaccines. Patient/Parent-level components: An iPad tablet-based educational presentation will be provided for parents while they are waiting with their adolescent child in the examination room.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Robert Bednarczyk, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186430 on ClinicalTrials.gov