The STOP-HPV Scale Up Study
2 other identifiers
interventional
100,000
1 country
1
Brief Summary
Human papillomavirus (HPV) causes 35,900 US cancer cases per year, 4,000 deaths, and $4 billion in can In this study, the investigators will conduct a 3-arm clustered randomized controlled trial (RCT) in an estimated 72 practices from up to 8 health systems to evaluate the effectiveness and cost effectiveness of two potentially scalable implementation strategies (based on prior work) to increase the initiation of HPV vaccine against a usual care (control) arm. The intervention arms are 1) online provider communication training only ("STOP-HPV-Online" and 2) online provider communication training plus a Learning Collaborative, with performance feedback, attended by practice leads ("STOP-HPV-LC). cer-related costs. It is recommended at ages 11-12 years routinely but can be given starting at ages 9-10 years. Despite having an effective vaccine, HPV vaccine initiation/completion rates in the U.S. were only at 76.8%/61.4% respectively in 2023 among 13-17 year olds; these rates are lower than the other recommended adolescent vaccines. Two key barriers are 1) suboptimal clinician communication to address parental concerns and 2) ineffective office systems causing missed vaccine opportunities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2025
CompletedFirst Posted
Study publicly available on registry
February 18, 2025
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 19, 2027
May 19, 2026
February 1, 2026
1.1 years
February 14, 2025
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with a participating provider during the intervention period.
The percent of children ages 9-\<13 years of age who received their first dose of HPV vaccine at or following a well child care visit with a participating provider during the intervention-period (denominator is children ages 9-\<13 with a well child visit during the study period at which they were due for their first dose).
12 months from start of intervention
Secondary Outcomes (4)
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with a participating provider during the intervention period.
12 months from start of intervention
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with any provider during the intervention period.
12 months from start of intervention
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with any provider during the intervention period.
12 months from start of intervention
Total implementation cost
12 months from start of intervention
Study Arms (3)
STOP-HPV Online
EXPERIMENTALProvider communication training
STOP-HPV LC
EXPERIMENTALProvider communication training plus Learning Collaborative sessions attended by practice leads and quarterly performance feedback to the practice.
Usual Care
NO INTERVENTIONStandard of care control
Interventions
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-Online intervention.
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-LC intervention.
Eligibility Criteria
You may qualify if:
- Patient of participating practice
- Well child care visit during the 12-month intervention period
- No prior dose of HPV vaccine at the time of the well child care visit
- Age-eligible
You may not qualify if:
- Prior dose of HPV vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Medical Group Associationcollaborator
- National Cancer Institute (NCI)collaborator
- University of California, Los Angeleslead
Study Sites (1)
AMGA
Alexandria, Virginia, 22314, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Szilagyi, MD, MPH
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 14, 2025
First Posted
February 18, 2025
Study Start
March 30, 2026
Primary Completion (Estimated)
April 19, 2027
Study Completion (Estimated)
April 19, 2027
Last Updated
May 19, 2026
Record last verified: 2026-02