PreTeenVax Evaluation

NCT03186430 | Completed

• 2 other identifiers: IRB00090382K01AI106961
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 6

Brief 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

Human Papilloma Virus

Keywords

Vaccine; Vaccination; Behavioral Research; Adolescent; Health Promotion; Public Health

Outcome Measures

Primary Outcomes (1)

• Initiation of HPV vaccine by adolescents

  During the follow-up interview, parents are asked if their child received the HPV vaccine during the visit with their pediatrician when they enrolled in this study. Possible responses are: * Yes, they received a dose of this vaccine * No, the received a dose of this vaccine before that visit * No, but they received a dose of this vaccine at a later visit * No, they have not received this vaccine * Don't know

  Month 3 Follow-Up

Secondary Outcomes (2)

• Vaccine Confidence Scale score

  Month 3 Follow-Up

• Provider perception of the intervention

  At the end of the study (about 2 years)

Study Arms (2)

Comprehensive Vaccine Promotion Package

EXPERIMENTAL

The pediatric practices randomized to this arm will receive the comprehensive adolescent vaccine promotion package. Practice physicians and staff will be familiarized with each component, and practices will be instructed to implement each vaccine-promotion component to the best of their ability.

Behavioral: Comprehensive Vaccine Promotion Package

Standard Vaccination Promotion

NO INTERVENTION

The pediatric practices randomized to the control arm will not receive the comprehensive vaccine promotion package and will instead be instructed to continue offering their standard adolescent vaccination promotion practices to adolescent patients.

Interventions

Comprehensive Vaccine Promotion Package BEHAVIORAL

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.

Comprehensive Vaccine Promotion Package

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescent males and females aged 11-12 years and their parents
• No previous receipt of any HPV vaccine dose by the adolescent

You may not qualify if:

• Not English speaking (adolescents and parents)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (6)

DV Pediatrics

Canton, Georgia, 30114, United States

Location

Crescent Pediatrics

Duluth, Georgia, 30097, United States

Location

Lawrenceville Pediatrics - Lawrenceville Office

Lawrenceville, Georgia, 30046, United States

Location

West Atlanta Pediatrics

Lithia Springs, Georgia, 30122, United States

Location

Lawrenceville Pediatrics - Loganville Office

Loganville, Georgia, 30052, United States

Location

Northlake Pediatric Associates

Stone Mountain, Georgia, 30087, United States

Location

Study Officials

• Robert Bednarczyk, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study uses a cluster-randomized design where six health provider practices are randomized to the intervention or control arm where all participants in the respective practices will receive the behavioral intervention or the standard information.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: June 14, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (6)