PreTeenVax Evaluation

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.

Parents are enrolled into the study based on their children meeting age and prior
vaccination requirements.

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)