PreTeenVax Evaluation

NCT ID: NCT03186430

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2018-07-31

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.

Detailed Description

Since the introduction of HPV vaccine, there have been a number of studies examining attitudes and barriers related to HPV vaccine uptake among adolescent and young adult women, parents, and healthcare providers. Through these surveys, a number of distinct themes regarding reasons for not taking the HPV vaccine have emerged, including lack of provider recommendation, lack of awareness about the vaccine and the need for vaccination, concerns about vaccine effectiveness, concerns about vaccine safety, the potential of a vaccine against a sexually transmitted infection to increase promiscuity, cost of the vaccine doses, and the lack of routine adolescent well-care visits. However, many of these studies have used endpoints related to HPV vaccine knowledge or intention to vaccinate rather than actual vaccination uptake. Interventions that use endpoints related to vaccination uptake rather than knowledge or intention to vaccinate, as well as those that address multiple levels of the healthcare decision making process, will be crucial in addressing routine immunization coverage among adolescents. At the end of the evaluation of this intervention package, the researchers of this study hope to have identified a comprehensive and easily scalable "shelf-ready" toolkit aimed at increasing uptake of vaccines that are indicated during adolescence. If successful, this package could easily be implemented on a national level.

In the evaluation study, the researchers will use a cluster-randomized trial design to test whether exposure to the intervention package increases the likelihood of vaccine receipt by an adolescent in a practice randomized to receive the intervention package compared to an adolescent in a practice randomized to the control (standard of care) arm. Participating pediatric practices will be pair-matched based on overall adolescent patient load and historical HPV vaccine uptake and pairs will be randomized to one of two study arms:

1. Intervention arm: 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.

2. Control arm: 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.

Parents of eligible adolescents at participating practices will be given the opportunity to take part in this study. At the initial visit, parents of adolescent patients 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Comprehensive Vaccine Promotion Package

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.

Group Type: EXPERIMENTAL

Comprehensive Vaccine Promotion Package

Intervention Type: 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.

Standard Vaccination Promotion

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Not English speaking (adolescents and parents)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Robert Bednarczyk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Bednarczyk, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

DV Pediatrics

Canton, Georgia, United States

Crescent Pediatrics

Duluth, Georgia, United States

Lawrenceville Pediatrics - Lawrenceville Office

Lawrenceville, Georgia, United States

West Atlanta Pediatrics

Lithia Springs, Georgia, United States

Lawrenceville Pediatrics - Loganville Office

Loganville, Georgia, United States

Northlake Pediatric Associates

Stone Mountain, Georgia, United States

Countries

United States

Other Identifiers

K01AI106961

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00090382

Identifier Type: -

Identifier Source: org_study_id