PCOM2 - The Physician Communication Intervention, Version 2.0

HPV Infection Clinical Trial

— PCOM2  

Official title:

PCOM2 - The Physician Communication Intervention, Version 2.0" for "Linking the Provider Recommendation to Adolescent HPV Vaccine Uptake"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336240
• Other study ID #: 21-4870
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Christine Spina, MSPH
• Phone: 303.724.0906
• Email: CHRISTINE.BABBEL[@]CUANSCHUTZ.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Poor quality of primary care providers' vaccine recommendations lead to low adolescent human papillomavirus vaccination rates and hundreds of thousands of adolescents unnecessarily at risk for HPV-associated cancers and diseases. Though a previous provider communication intervention, called PCOM, was found to be effective for increasing adolescent HPV vaccination in primary care, its dissemination is limited by the need for significant research team involvement to teach providers how to use the intervention's components. To address this, investigators propose to develop and test a virtual version of PCOM, use mixed methods to assess contextual factors affecting its use compared to the original PCOM intervention, and develop an optimized version of PCOM for broad dissemination to increase adolescent HPV vaccination nationally.

Description:

The overarching goal is to develop a "Virtual" version of the PCOM intervention ("PCOM-Virtual") and compare its efficacy for increasing HPV vaccination among adolescents to that of the original PCOM intervention ("PCOM-Standard"). Using Dissemination & Implementation (D&I) science principles to develop and evaluate the PCOM-Virtual intervention for non-inferiority, investigators anticipate that to have a "shelf ready" intervention and associated "User Manual" that can be easily incorporated into practices broadly to improve the practice's adolescent HPV vaccination rates.

Specific Aims are to: (1) develop the "PCOM-Virtual" intervention using principles of D&I Science; (2) compare the efficacy of "PCOM-Virtual" versus "PCOM-Standard" in improving adolescent HPV vaccine utilization; and (3) examine whether practice, patient and provider characteristics are associated with variability in the efficacy of PCOM-Virtual and PCOM-Standard.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Parents: Have an adolescent between the ages of 9-17 years old and receiving adolescent care at an enrolled clinic

• Providers: All providers at participating study practices will be eligible to participate.

Exclusion Criteria:

• Parents: Does not have an adolescent between the ages of 9-17 years old and is not receiving adolescent care at an enrolled clinic

• Providers: Providers who are not at participating study practices

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections
• Preventive Health Services

Intervention

Behavioral:
• Physician Communication 2 Virtual (PCOM2-virtual)
The PCOM-standard intervention is based off of a provider communication training that utilizes presumptive technique when initiating the vaccine discussion followed by motivational interviewing if a parent continues to show hesitation. While this provider communication technique previously showed success in increasing HPV vaccination uptake, it is neither easy to disseminate nor sustainable due to it's nature of direct, intensive in-person training. Therefore, the intervention is to compare the standard-PCOM intervention to a new, PCOM2 intervention, that will be adapted virtually.
• Physician Communication Standard (PCOM-standard)
The PCOM-standard intervention is based off of a provider communication training that utilizes presumptive technique when initiating the vaccine discussion followed by motivational interviewing if a parent continues to show hesitation. PCOM-standard will be conducted in-person with providers.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Kansas Medical Center	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Mercy Hospital Kansas City, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccination initiation status in 11-12 year olds	The primary outcome to be assessed in the trial is HPV vaccine series initiation among 11-12-year-olds as 11-12 year-olds are the preferred target population for HPV vaccination and the PCOM intervention had its strongest effect on series initiation rather than completion.	Adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period
Secondary	HPV series completion among 11-12 year olds	Secondary outcome to assess HPV series completion among 11-12-year-olds	Adolescent vaccination completion status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period
Secondary	HPV vaccination initiation status in 13-17 year olds	Secondary outcome to assess "catch-up" HPV vaccine series initiation among 13-17-year-olds	Adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 13-17-year-old patients at each practice during the last 12 months of the 24 month intervention period
Secondary	HPV series completion among 13-17 year olds	Secondary outcome to assess "catch-up" HPV vaccine series completion among 13-17 year-olds.	Adolescent vaccination completion status will be assessed among all "active" (seen in the last 12 months) 13-17-year-old patients at each practice during the last 12 months of the 24 month intervention period