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

Background: The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates.

Methods: This 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11–14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months.

Discussion: We expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers.

Trial registration: ClinicalTrials.gov NCT04587167. Registered on October 14, 2020.

© This manuscript version is made available under the CC-BY-NC-ND 4.0 license https://creativecommons.org/licenses/by-nc-nd/4.0/

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Work Title 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
Access
Open Access
Creators
  1. William A. Calo
  2. Parth D. Shah
  3. Benjamin N. Fogel
  4. Mack T. Ruffin IV
  5. Jennifer L. Moss
  6. Bernice L. Hausman
  7. Joel E. Segel
  8. Erica Francis
  9. Eric Schaefer
  10. Chelsea M. Bufalini
  11. Nikole Johnston
  12. Ellie Hogentogler
  13. Jennifer L. Kraschnewski
Keyword
  1. Human papillomavirus vaccine
  2. Vaccine communication
  3. Healthcare providers
  4. Primary care clinics
  5. Vaccine hesitancy
  6. Implementation outcomes
License CC BY-NC-ND 4.0 (Attribution-NonCommercial-NoDerivatives)
Work Type Article
Publisher
  1. Contemporary Clinical Trials
Publication Date June 14, 2023
Publisher Identifier (DOI)
  1. https://doi.org/10.1016/j.cct.2023.107266
Deposited March 04, 2024

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Version 1
published

  • Created
  • Added HPV_ECHO_protocol_clean.docx
  • Added Tables_Figures_v4.docx
  • Added Creator William A. Calo
  • Added Creator W Alexis Calo Perez
  • Added Creator Parth D. Shah
  • Added Creator Benjamin N. Fogel
  • Added Creator M T. Ruffin
  • Added Creator Mack T. Ruffin IV
  • Added Creator Jennifer L. Moss
  • Added Creator Bernice L. Hausman
  • Added Creator Joel E. Segel
  • Added Creator Erica Francis
  • Added Creator Eric Schaefer
  • Added Creator Chelsea M. Bufalini
  • Added Creator Nikole Johnston
  • Added Creator Ellie Hogentogler
  • Added Creator Jennifer L. Kraschnewski
  • Published
  • Updated Keyword, Description, Publication Date Show Changes
    Keyword
    • Human papillomavirus vaccine, Vaccine communication, Healthcare providers, Primary care clinics, Vaccine hesitancy, Implementation outcomes
    Description
    • <p>Background: The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates. Methods: This 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11–14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months. Discussion: We expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers. Trial registration: ClinicalTrials.gov NCT04587167. Registered on October 14, 2020.</p>
    • <p>Background: The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates.
    • Methods: This 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11–14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months.
    • Discussion: We expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers.
    • Trial registration: ClinicalTrials.gov NCT04587167. Registered on October 14, 2020.</p>
    Publication Date
    • 2023-07-01
    • 2023-06-14
  • Deleted Creator W Alexis Calo Perez
  • Deleted Creator M T. Ruffin
  • Updated Creator Parth D. Shah
  • Updated Creator Benjamin N. Fogel
  • Updated Creator Mack T. Ruffin IV
  • Updated Creator Jennifer L. Moss
  • Updated Creator Bernice L. Hausman
  • Updated Creator Joel E. Segel
  • Updated Creator Erica Francis
  • Updated Creator Eric Schaefer
  • Updated Creator Chelsea M. Bufalini
  • Updated Creator Nikole Johnston
  • Updated Creator Ellie Hogentogler
  • Updated Creator Jennifer L. Kraschnewski
  • Updated