The STOP-HPV Scale Up Study
NCT06831383 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100000
Last updated 2026-05-19
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.
Conditions
- Human Papilloma Virus Vaccine
Interventions
- BEHAVIORAL
-
STOP-HPV-Online
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-Online intervention.
- BEHAVIORAL
-
STOP-HPV-LC
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-LC intervention.
Sponsors & Collaborators
-
American Medical Group Association
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Peter Szilagyi, MD, MPH · University of California, Los Angeles
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-30
- Primary Completion
- 2027-04-19
- Completion
- 2027-04-19
Countries
- United States
Study Locations
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