Clinical trial NCT04587167: HPV Vaccine Communication ECHO for Primary Care Clinics
Official title: HPV ECHO: Increasing the Adoption of Evidence-based Communication Strategies for HPV Vaccination in Rural Primary Care Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Vaccines
Adolescent Health Services
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.

Detailed description: The investigators will recruit 36 primary care clinics (family medicine and pediatric) in Pennsylvania. Eligible clinics will have at least 100 active patients, ages 11-14, in their electronic health record systems. Recruitment will target clinics in Central Pennsylvania, where most counties are designated as rural. Clinics will be randomized to one of three arms: ECHO-delivered HPV vaccine communication training using the Announcement Approach (HPV ECHO); HPV ECHO plus systems follow-up communication for parents who initially decline vaccination (HPV ECHO+); or control. Covariate-constrained randomization will be used to ensure balance among the three arms with respect to clinic size (adolescent patient population), clinic type (academic vs. non-academic), rurality, and historic adolescent HPV vaccination rates.

Eligibility criteria: Clinics in cluster RCT (main study)

Inclusion Criteria:

* Family medicine or pediatric clinic in Pennsylvania
* Having at least 100 active patients, ages 11-14.

Exclusion Criteria:

* Primary care clinic outside Pennsylvania
* Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months.

Parents in nested study survey

Inclusion criteria:

* Parent or guardian of an adolescent ages 11-17
* Adolescent has not yet started HPV vaccination
* Adolescent receive primary care at participating clinic

Exclusion criteria:

* Not the parent or guardian of an adolescent ages 11-17
* Adolescent already initiated HPV vaccination
* Adolescent does not receive primary care at participating clinic

Primary outcomes:
measure: HPV vaccination (≥1 dose), 11-14 year olds at 12 months
timeFrame: Twelve months
Secondary outcomes:
measure: HPV vaccination (≥1 dose), 11-14 year olds at 3 months
timeFrame: Three months
measure: HPV vaccination (≥1 dose), 11-14 year olds at 6 months
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 11-14 year olds at 9 months
timeFrame: Nine months
measure: HPV vaccination (completion), 11-14 year olds at 3 months
timeFrame: Three months
measure: HPV vaccination (completion), 11-14 year olds at 6 months
timeFrame: Six months
measure: HPV vaccination (completion), 11-14 year olds at 9 months
timeFrame: Nine months
measure: HPV vaccination (completion), 11-14 year olds at 12 months
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 15-17 year olds at 3 months
timeFrame: Three months
measure: HPV vaccination (≥1 dose), 15-17 year olds at 6 months
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 15-17 year olds at 9 months
timeFrame: Nine months
measure: HPV vaccination (≥1 dose), 15-17 year olds at 12 months
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 11-14 year olds at 12 months by sex
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 15-17 year olds at 12 months by sex
timeFrame: Twelve months
Other outcomes:
measure: Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-14 year olds
timeFrame: Twelve months
measure: Meningococcal vaccination (≥1 dose), 11-14 year olds
timeFrame: Twelve months
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: William A Calo, PhD, JD, MPH
role: PRINCIPAL_INVESTIGATOR
References: