HPV Infection, Preventive Health Services
Conditions
Keywords
Immunization, Provider Communication, HPV Prevention
Brief 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.
Detailed 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.
Interventions
BEHAVIORALPhysician 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.
BEHAVIORALPhysician 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.
Sponsors
University of Kansas Medical Center
San Diego State University
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysts on the study team
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV vaccination initiation status in 11-12 year olds | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 outcome to assess HPV series completion among 11-12-year-olds |
| HPV vaccination initiation status in 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 outcome to assess catch-up HPV vaccine series initiation among 13-17-year-olds |
| HPV 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 | Secondary outcome to assess catch-up HPV vaccine series completion among 13-17 year-olds. |
Countries
United States
Contacts
Primary ContactChristine Spina, MSPH
Backup ContactJulian Dedeaux
Outcome results
None listed