STOP-HPV scale-up to increase HPV vaccination in clinics
The STOP-HPV Scale Up Study
This trial will test two ways of training clinic teams to see if they increase HPV vaccine starts for 9–12 year olds at well-child visits compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100000 (estimated) |
| Ages | 9 Years to 17 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Alexandria, Virginia) |
| Trial ID | NCT06831383 on ClinicalTrials.gov |
What this trial studies
This is a three-arm, cluster randomized trial that will randomize about 72 primary care practices across up to eight U.S. health systems to one of two implementation strategies or usual care. One arm delivers online provider communication training only (STOP-HPV-Online) and the other adds a Learning Collaborative with performance feedback for practice leads (STOP-HPV-LC); health systems will deploy the interventions with AMGA support as needed. The primary outcome is HPV vaccine initiation among 9 to <13 year olds during a 12-month intervention period, with fidelity monitoring and cost-effectiveness analysis. The design builds on prior work that produced modest improvements when interventions were delivered by the research team and tests whether those gains hold when scaled and run by health systems.
Who should consider this trial
Good fit: Ideal candidates are patients aged about 9 to <13 years who attend a participating practice for a well-child visit and have not yet received any HPV vaccine dose.
Not a fit: Patients who have already received any HPV vaccine dose or who are outside the eligible age range are unlikely to benefit from the interventions in this trial.
Why it matters
Potential benefit: If successful, the interventions could increase HPV vaccine initiation in age-eligible patients and thereby reduce future HPV-related cancers.
How similar studies have performed: Prior investigator-led studies showed modest increases in initiation (about 6.8% for online training and ~8% when combined with a learning collaborative), but this trial tests whether those effects can be replicated when health systems implement the strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior dose of HPV vaccine
Where this trial is running
Alexandria, Virginia
- Amga — Alexandria, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Peter Szilagyi, MD, MPH — University of California, Los Angeles
- Study coordinator: Peter Szilagyi, MD, MPH
- Email: pszilagyi@mednet.ucla.edu
- Phone: 310-206-6328
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.