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OpenTrials
Completed

NCT Number: NCT04587167

HPV Vaccine Communication ECHO for Primary Care Clinics

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.

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Key information

Conditions

Human Papillomavirus Vaccines Adolescent Health Services

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project ECHO

Other

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.

Other names: ECHO Model

Announcement Approach Training

Other

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

Other

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.

Primary outcomes

  1. HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months

    Time frame: Twelve 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

Secondary outcomes

  1. HPV Vaccination (≥1 Dose), 11-14 Year Olds at 3 Months

    Time frame: Three 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

  2. HPV Vaccination (≥1 Dose), 11-14 Year Olds at 6 Months

    Time frame: Six 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

  3. HPV Vaccination (≥1 Dose), 11-14 Year Olds at 9 Months

    Time frame: Nine 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

  4. HPV Vaccination (Completion), 11-14 Year Olds at 3 Months

    Time frame: Three 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

  5. HPV Vaccination (Completion), 11-14 Year Olds at 6 Months

    Time frame: Six 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

  6. HPV Vaccination (Completion), 11-14 Year Olds at 9 Months

    Time frame: Nine 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

  7. HPV Vaccination (Completion), 11-14 Year Olds at 12 Months

    Time frame: Twelve 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

  8. HPV Vaccination (≥1 Dose), 15-17 Year Olds at 3 Months

    Time frame: Three 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

  9. HPV Vaccination (≥1 Dose), 15-17 Year Olds at 6 Months

    Time frame: Six 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

  10. HPV Vaccination (≥1 Dose), 15-17 Year Olds at 9 Months

    Time frame: Nine 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

  11. HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months

    Time frame: Twelve 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

  12. HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months by Sex

    Time frame: Twelve months

    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

  13. HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months by Sex

    Time frame: Twelve months

    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

Other outcomes

  1. Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination, 11-14 Year Olds

    Time frame: Twelve months

    Coverage change from baseline to 12 months in Tdap vaccination among 11- to 14-year-old patients, as measured by clinics' records

  2. Meningococcal Vaccination (≥1 Dose), 11-14 Year Olds

    Time frame: Twelve months

    Coverage change from baseline to 12 months in meningococcal vaccination (≥1 dose), among 11- to 14-year-old patients, as measured by clinics' records

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Oct 14, 2020
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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