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Clinical Trial NCT06831383 for Human Papilloma Virus Vaccine is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The STOP-HPV Scale Up Study 100,000 Vaccine Study Randomized Adolescent

Recruiting
Clinical Trial NCT06831383 is an interventional study for Human Papilloma Virus Vaccine that is recruiting. It started on March 23, 2026 with plans to enroll 100,000 participants. Led by University of California, Los Angeles, it is expected to complete by April 19, 2027. The latest data from ClinicalTrials.gov was last updated on February 27, 2026.
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...Show More
Detailed Description
In prior work, the investigators have tested two implementation strategies/interventions that were effective, but which were deployed by the research team. The first is provider communication training ("STOP-HPV-Online"), delivered by the research team, in a cluster RCT in 48 pediatric practices from a research network (6.8% improvement in initiation). The other is a quality improvement, pre-post study, that included...Show More
Official Title

The STOP-HPV Scale Up Study

Conditions
Human Papilloma Virus Vaccine
Other Study IDs
NCT ID Number
NCT06831383
Start Date (Actual)
2026-03-23
Last Update Posted
2026-02-27
Completion Date (Estimated)
2027-04-19
Enrollment (Estimated)
100,000
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Human Papillomavirus Vaccination
Practice-based improvement
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSTOP-HPV Online
Provider communication training
STOP-HPV-Online
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-Online intervention.
ExperimentalSTOP-HPV LC
Provider communication training plus Learning Collaborative sessions attended by practice leads and quarterly performance feedback to the practice.
STOP-HPV-LC
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-LC intervention.
No InterventionUsual Care
Standard of care control
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
The percent of children ages 13-17 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 13-17 years with a well child visit during the study period at which they were due for their first dose).
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.
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 any provider (participating or not) 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
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.
The percent of children ages 13-17 years of age who received their first dose of HPV vaccine at or following a well child care visit with any provider (participating or not) during the intervention-period (denominator is children ages 13-17 years with a well child visit during the study period at which they were due for their first dose).
12 months from start of intervention
Total implementation cost
The difference in costs between arms will be used to calculate the incremental cost-effectiveness ratio (ICER)
12 months from start of intervention
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
9 Years
Eligible Sexes
All
  • 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

  • Prior dose of HPV vaccine
University of California, Los Angeles logoUniversity of California, Los Angeles341 active studies to explore
Study Responsible Party
Peter G Szilagyi, MD MPH, Principal Investigator, Professor, University of California, Los Angeles
Study Central Contact
Contact: Peter Szilagyi, MD, MPH, 310-206-6328, [email protected]
Contact: Christina Albertin, PhD, MPH, 317-701-4926, [email protected]
1 Study Locations in 1 Countries

Virginia

AMGA, Alexandria, Virginia, 22314, United States
Cindy Shekailo, Contact, 703-838-0033, [email protected]
Recruiting