NCT05336240ClinicalTrials.gov
PCOM2 - The Physician Communication Intervention, Version 2.0
PCOM2 - The Physician Communication Intervention, Version 2.0" for "Linking the Provider Recommendation to Adolescent HPV Vaccine Uptake"
In brief
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…
Interventional120 participants sought2 sites1 country
Categories
Registered in 1 registry
- ClinicalTrials.govNCT05336240Open this record at ClinicalTrials.govSynced 2 months ago
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2022-04-20; recorded start 2023-11-15
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Present: Uses blinding (masking)A masking level is recorded in the record
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 475 other studies in this databaseCounted from the lead sponsor named in the record (University of Colorado, Denver)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 2 conditions.
- Lead sponsor type recorded as: other.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding7/20
Single-blind
- Control arm15/15
Active-comparator control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre5/8
Multi-centre: 2 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A small study: 120 participants (target), run at 2 sites.
How this score is built
- Enrolment19/40
120 participants (target)
- Site count4/25
2 sites
- Country count0/15
Single country
- Planned duration8/10
Planned over about 38 months
- Sponsor scale10/10
University of Colorado, Denver has led 468 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
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.
Conditions
- HPV Infection
- Preventive Health Services
Eligibility
| Sex | All |
|---|---|
| Ages | 9 Years – 17 Years |
| Healthy volunteers | No |
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Interventional |
|---|---|
| Phase | Not applicable |
| Allocation | Randomised |
| Intervention model | PARALLEL |
| Primary purpose | HEALTH_SERVICES_RESEARCH |
| Masking | SINGLE (1) |
| Enrolment | 120 participants sought |
Sponsor and collaborators
- University of Colorado, Denver Sponsor
- University of Kansas Medical Center Collaborators
- San Diego State University Collaborators
Arms and interventions
- PCOM Standard ArmACTIVE_COMPARATOR
Providers in participating in the PCOM-standard intervention will be trained on optimizing an in-person provider communication technique about HPV vaccination by training primary care providers in a 2-step verbal communication process: 1) to start the HPV vaccine discussion using a "presumptive" format, and 2) to use motivational interviewing (MI) techniques to address parental vaccine hesitancy.
- PCOM2 Virtual ArmEXPERIMENTAL
Providers participating in the PCOM2-virtual arm will receive training on this communication method through an adapted virtual model of PCOM-standard. PCOM2-Virtual intervention will result in 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. PCOM-Virtual arm will then be compared to that of the original PCOM-standard intervention in its efficacy for increasing HPV vaccination among adolescents.
Interventions
- Behavioural 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.
- Behavioural 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.
Outcome measures
Primary outcome
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.
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
Secondary outcome
HPV series completion among 11-12 year olds
Secondary outcome to assess 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
HPV vaccination initiation status in 13-17 year olds
Secondary outcome to assess "catch-up" HPV vaccine series initiation among 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
HPV series completion among 13-17 year olds
Secondary outcome to assess "catch-up" HPV vaccine 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
Dates
| Start date | November 15, 2023 (actual) |
|---|---|
| Primary completion | December 31, 2025 (estimated) |
| Completion | December 31, 2026 (estimated) |
| First posted | April 20, 2022 (actual) |
| Last updated | August 26, 2024 |
| Results posted | Not stated in the registry record |
| Status last verified | August 2024 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
2 sites are recruiting
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| University of Kansas Medical Center | Wichita | Kansas | Recruiting |
Study documents
No documents are linked in this registry record.
Changes over time
No changes have been recorded since we first ingested this record.
A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.