PreTeenVax Evaluation
Condition: Human Papilloma Virus
MeSH terms: Papilloma
Study type: Interventional

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.
    

Intervention name(s): Comprehensive Vaccine Promotion Package
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Vaccine; Vaccination; Behavioral Research; Adolescent; Health Promotion; Public Health