N/A
N=104,438
The STOP-HPV Trial 1: Communication Intervention
Immunization · Vaccination
Bottom Line
View on ClinicalTrials.gov: NCT03599557 ↗Enrolled (actual)
104,438
Serious AEs
—
Results posted
Jul 2024
Primary outcome: Primary: Change in the Rate of Missed Vaccination Opportunities Among All Clinicians — 37063; 40764; 14932; 18343 Eligible visits (due for vaccine)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STOP-HPV communication intervention (Behavioral)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Rate of Missed Vaccination Opportunities Among All Clinicians |
37063; 40764; 14932; 18343 | — |
| PRIMARY Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians |
25117; 27817; 11152; 13193 | — |
Summary
Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.
Eligibility Criteria
Practice Inclusion Criteria:
- The practice provides HPV vaccination services to adolescents.
- The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
- The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
- The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).
Practice Exclusion Criteria:
- The practice plans to change EHR systems in the next three years.
- The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
- Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).
Patient inclusion criteria:
-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.
Patient exclusion criteria:
-None apart from age of patients (above).
Data sourced from ClinicalTrials.gov (NCT03599557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.