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NCT Number: NCT05336240

PCOM2 - The Physician Communication Intervention, Version 2.0

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.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Preventive Health Services Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Physician Communication 2 Virtual (PCOM2-virtual)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. HPV vaccination initiation status in 11-12 year olds

    Time frame: 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

    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.

Secondary outcomes

  1. HPV series completion among 11-12 year olds

    Time frame: 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 outcome to assess HPV series completion among 11-12-year-olds

  2. HPV vaccination initiation status in 13-17 year olds

    Time frame: 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 outcome to assess "catch-up" HPV vaccine series initiation among 13-17-year-olds

  3. HPV series completion among 13-17 year olds

    Time frame: 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

    Secondary outcome to assess "catch-up" HPV vaccine series completion among 13-17 year-olds.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Spina, MSPH

CONTACT

[email protected]

303.724.0906

Julian Dedeaux

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • San Diego State University
  • University of Kansas Medical Center

Registry information

Official study title

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

Acronym: PCOM2

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Aug 26, 2024

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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