Human Papilloma Virus
Conditions
Keywords
Human Papilloma Virus, vaccination, adolescent medicine, primary care, clinical champions
Brief summary
This trial will compare two ways to improve communication about HPV vaccination in primary care. The research team will work with primary care clinics. Some clinics will receive communication training from an outside expert. Other clinics will receive the same training from a vaccine champion from their healthcare system.
Detailed description
The researchers will conduct a cluster randomized non-inferiority trial. The trial will compare two ways of delivering a communication workshop called Announcement Approach Training (AAT). AAT is designed to improve communication about HPV vaccination in primary care. The researchers will randomize clinics within participating healthcare systems. Some clinics will receive the training from an outside expert. Other clinics will receive the same training from a vaccine champion from their own system. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 12 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
Interventions
BEHAVIORALChampion Announcement Approach Training
AAT is a one-hour communication workshop that trains clinical staff how to recommend HPV vaccine for children ages 9-12. In the champion arm, vaccine champions will deliver the training using slides and a standardized script. They will also conduct outreach and sustainability planning.
BEHAVIORALTraditional Announcement Approach Training
AAT is a one-hour communication workshop that trains clinical staff how to recommend HPV vaccine for children ages 9-12. In the traditional arm, outside experts will deliver the training using the same slides and script.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
cluster randomized design in which clinics will be randomized within healthcare systems
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly. Inclusion Criteria Clinics are eligible if they: * provide primary care to children ages 9-12 * specialize in pediatrics or family medicine Children's medical records will be eligible to be included in the dataset if children: * are between the ages of 9-12 years at baseline * are attributed to a participating clinic at 12-month follow-up
Exclusion criteria
Clinics are excluded if they: * do not provide primary care to children ages 9-12 * have a specialty other than pediatrics or family medicine Children's medical records will be excluded if children: * are not between the ages of 9-12 years at baseline * are not attributed to a participating clinic at 12-month follow-up * are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV vaccination (≥1 dose), 9-12 year olds | from baseline to 12 months | Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV vaccination (2 doses), 9-12 year olds | from baseline to 12 months | Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNoel T Brewer, PhD
University of North Carolina
Outcome results
None listed