HPV Vaccine Communication ECHO for Primary Care Clinics

NCT04587167 | Completed Results

• 2 other identifiers: STUDY00015734R37CA253279
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Vaccines; Adolescent Health Services

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

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

  Three months

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

  Six months

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

  Nine months

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

  Three months

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

  Six months

Other Outcomes (2)

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

  Twelve months

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

  Twelve months

Study Arms (3)

HPV ECHO

EXPERIMENTAL

Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.

Other: Project ECHO; Other: Announcement Approach Training

HPV ECHO+

EXPERIMENTAL

Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.

Other: Project ECHO; Other: Announcement Approach Training; Other: Recall notices

Control

NO INTERVENTION

Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.

Interventions

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.

Also known as: ECHO Model

HPV ECHO; HPV ECHO+

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.

HPV ECHO; HPV ECHO+

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.

HPV ECHO+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Calo WA, Shah PD, Fogel BN, Ruffin Iv MT, Moss JL, Hausman BL, Segel JE, Francis E, Schaefer E, Bufalini CM, Johnston N, Hogentogler E, Kraschnewski JL. Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107266. doi: 10.1016/j.cct.2023.107266. Epub 2023 Jun 9.

  PMID: 37301468 DERIVED

Limitations and Caveats

Challenges occurred in obtaining aggregate immunization data. Three clinics did not submit data, and others could not consistently follow the same patient cohort across time points, resulting in inconsistencies. The study team collaborated with clinics and EHR servicers to ensure the highest possible data quality.

Results Point of Contact

• Title: William Calo
• Organization: Milton S. Hershey Medical Center

wcalo@pennstatehealth.psu.edu

717-531-3535

Study Officials

• William A Calo, PhD, JD, MPH

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Cluster randomized design

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: May 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: April 30, 2025
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)