Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03824093 |
| Other study ID # |
ChildrensMHC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2018 |
| Est. completion date |
May 6, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Children's Mercy Hospital Kansas City |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Human Papillomavirus (HPV) is a significant public health issue affecting nearly 14 million
people in the United States. HPV can lead to cervical, oropharyngeal, anal, and penile
cancers as well as genital warts.The purpose of this study is to test the comparative
effectiveness of two interventions, AFIX only vs. AFIX + communication training, to increase
Human Papillomavirus (HPV) vaccination rates among adolescent patients in outpatient clinic
settings. Providers and staff at four pediatric practices will be randomized to receive an
in-person AFIX consultation or an AFIX consultation combined with communication training and
commitment poster displays. Provider and parent data will be collected via a tablet computer
RedCap survey. Additional practice and provider level HPV vaccination rates will be collected
via patient de-identified claims data. The results of this study could contribute to the
existing body of literature that suggests provider recommendations and routine vaccination
assessments are key to increasing HPV vaccination uptake. This project has the potential to
lead to the implementation and dissemination of low resource interventions to increase HPV
vaccination rates among children and adolescents.
Description:
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.
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