The STOP-HPV Scale Up Study

Conditions

• Human Papilloma Virus Vaccine

Eligibility Criteria

Sex

ALL

Age

9 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• STOP-HPV-Online — BEHAVIORAL
  Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-Online intervention.
• STOP-HPV-LC — BEHAVIORAL
  Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-LC intervention.

Study Details

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.

Key Dates

Start date

Mar 30, 2026

Status verified

Feb 2026

Primary completion

Apr 19, 2027

Completion

Apr 19, 2027

Study Design

Enrollment

100,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: STOP-HPV Online
  Provider communication training
• Experimental: STOP-HPV LC
  Provider communication training plus Learning Collaborative sessions attended by practice leads and quarterly performance feedback to the practice.
• No Intervention: Usual Care
  Standard of care control

Primary Outcome Measure

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. [ Time Frame: 12 months from start of intervention ]

Central Contacts

• Peter Szilagyi, MD, MPH
  310-206-6328
  [email protected]
• Christina Albertin, PhD, MPH
  317-701-4926
  [email protected]

Locations (1)

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