HPV Vaccine Communication ECHO for Primary Care Clinics

Human Papillomavirus Vaccines Clinical Trial

Official title:

HPV ECHO: Increasing the Adoption of Evidence-based Communication Strategies for HPV Vaccination in Rural Primary Care Practices

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04587167
• Other study ID #: STUDY00015734
• Secondary ID: R37CA253279
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Health Services
• Human Papillomavirus Vaccines

Intervention

Other:
• Project ECHO
Using proven adult learning techniques and interactive video technology, the ECHO Model promotes knowledge exchange between experts or specialists at centers of excellence ("the hub") and primary care providers (the "spokes), typically located in rural settings. Through regular real-time collaborative sessions, the spokes connect with the hub and with other spokes to discuss 1) best practices in care and 2) complex cases managed within their practice.
• Announcement Approach Training
Train physicians and their clinic staff to make strong HPV vaccine recommendations by using presumptive announcements. If parents show vaccine hesitancy, the Training train physicians a 3-step approach (Connect, Clarify, Counsel) to share effective, evidence-based messages about HPV vaccine.
• Recall notices
Notify parents that their child is behind for HPV vaccination. Recall notices will include research-tested messages to specifically address parent concerns. Recall notices will be sent to parents via patient portal or email communication.

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-14 year olds	Coverage change from baseline to 12 months in Tdap vaccination among 11- to 14-year-old patients, as measured by clinics' records	Twelve months
Other	Meningococcal vaccination (=1 dose), 11-14 year olds	Coverage change from baseline to 12 months in meningococcal vaccination (=1 dose), among 11- to 14-year-old patients, as measured by clinics' records	Twelve months
Primary	HPV vaccination (=1 dose), 11-14 year olds at 12 months	Coverage change from baseline to 12 months in HPV vaccine initiation (=1 dose), among 11- to 14- year old patients, as measured by clinics' records	Twelve months
Secondary	HPV vaccination (=1 dose), 11-14 year olds at 3 months	Coverage change from baseline to 3 months in HPV vaccine initiation (=1 dose), among 11- to 14- year old patients, as measured by clinics' records	Three months
Secondary	HPV vaccination (=1 dose), 11-14 year olds at 6 months	Coverage change from baseline to 6 months in HPV vaccine initiation (=1 dose), among 11- to 14- year old patients, as measured by clinics' records	Six months
Secondary	HPV vaccination (=1 dose), 11-14 year olds at 9 months	Coverage change from baseline to 9 months in HPV vaccine initiation (=1 dose), among 11- to 14- year old patients, as measured by clinics' records	Nine months
Secondary	HPV vaccination (completion), 11-14 year olds at 3 months	Coverage change from baseline to 3 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records	Three months
Secondary	HPV vaccination (completion), 11-14 year olds at 6 months	Coverage change from baseline to 6 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records	Six months
Secondary	HPV vaccination (completion), 11-14 year olds at 9 months	Coverage change from baseline to 9 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records	Nine months
Secondary	HPV vaccination (completion), 11-14 year olds at 12 months	Coverage change from baseline to 12 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records	Twelve months
Secondary	HPV vaccination (=1 dose), 15-17 year olds at 3 months	Coverage change from baseline to 3 months in HPV vaccine initiation (=1 dose), among 15- to 17- year old patients, as measured by clinics' records	Three months
Secondary	HPV vaccination (=1 dose), 15-17 year olds at 6 months	Coverage change from baseline to 6 months in HPV vaccine initiation (=1 dose), among 15- to 17- year old patients, as measured by clinics' records	Six months
Secondary	HPV vaccination (=1 dose), 15-17 year olds at 9 months	Coverage change from baseline to 9 months in HPV vaccine initiation (=1 dose), among 15- to 17- year old patients, as measured by clinics' records	Nine months
Secondary	HPV vaccination (=1 dose), 15-17 year olds at 12 months	Coverage change from baseline to 12 months in HPV vaccine initiation (=1 dose), among 15- to 17- year old patients, as measured by clinics' records	Twelve months
Secondary	HPV vaccination (=1 dose), 11-14 year olds at 12 months by sex	Coverage change from baseline to 12 months in HPV vaccine initiation (=1 dose), among 11- to 14- year old patients by sex, as measured by clinics' records	Twelve months
Secondary	HPV vaccination (=1 dose), 15-17 year olds at 12 months by sex	Coverage change from baseline to 12 months in HPV vaccine initiation (=1 dose), among 15- to 17- year old patients by sex, as measured by clinics' records	Twelve months