High and Low Resource Interventions to Promote HPV Vaccines

Significance: Human Papillomavirus (HPV) is the most common sexually transmitted infection in
the United States with an estimated 14 million new infections each year. While most HPV
infections resolve without any symptoms or signs of infection, some HPV infections can lead
to genital warts and cancer. Every year, more than 30,000 people are affected by an
HPV-related cancer, including cervical, oropharyngeal, vaginal and anal cancers. Because most
adults will become infected with HPV at some point in their lives, the CDC recommends routine
vaccination for girls aged 11-26 and boys aged 11-21. While vaccines to prevent HPV infection
have been widely available for more than a decade nearly 38% of eligible girls and 50% of
eligible boys have not initiated the HPV vaccine series and more than 70% of boys and 50% of
girls have not completed the full vaccine series. Rates of HPV vaccination are significantly
lower than rates for other adolescent recommended vaccines including, tetanus, diptheria, and
acellular pertussis (Tdap), and meningococcal conjugate (MenACWY), which range from 81 to 86
percent. There are many factors that contribute to less than optimal HPV vaccination rates
but chief among them is lack of a strong provider recommendation to initiate and complete the
HPV vaccine series.

Innovation: This study will be the first randomized controlled trial comparing the
effectiveness of an AFIX intervention vs. an AFIX intervention combined with a provider
"nudge" that includes a brief communication skills training and commitment messaging displays
to increase HPV vaccination rates in pediatric outpatient settings.

Approach: 200 eligible parents (or caregivers) of adolescents between the ages of 11 and 18
will be enrolled and exposed to one of the interventions based on their clinic location.
Parents will be recruited from the Children's Mercy Hospital Primary Care Clinic (CMH PCC)
and Cradle Thru College Care Pediatrics in Kansas City, MO, Preferred Pediatrics in Lee's
Summit, MO, and Cass County Pediatrics in Belton,MO. Practices will be randomized to receive
either an in-person AFIX assessment or an in-person AFIX assessment combined with a brief,
provider communication training and adolescent vaccine commitment poster displays. The
primary outcome of this study is HPV vaccination rates. A secondary outcome is parent ratings
of satisfaction with their child's visit with the health care provider. Data will be
collected via a tablet computer administered RedCap survey in the exam room immediately
following the child's visit.

Public Health Impact: This study could have a significant public health impact and contribute
to meeting the Healthy People 2020 goals to reduce vaccine preventable infections by
increasing vaccination rates in the pediatric population.

Inclusion Criteria:

- Parent or legal guardian of a child 11-18 years of age or a pediatric health care
provider

- Parent or legal guardian of a child being seen for a well-child visit

- Ability to provide informed consent

Exclusion Criteria:

- Prior participation in the study

- Unable to read or understand English