NCT06380114 Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination
| NCT ID | NCT06380114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Hpv |
| Study Type | INTERVENTIONAL |
| Enrollment | 16,000 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16,000 participants in total. It began in 2024-11-04 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time. Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 9-17 year-olds.
Eligibility Criteria
Inclusion Criteria: * active patient in AHP practice Exclusion Criteria: * patient belonging to a practice with \>80% UTD baseline HPV vaccination rate for ages 13-17 * patient belonging to a practice with \<20 11-12 year-olds eligible for an HPV dose
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06380114 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 17 Years, studying Hpv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06380114 currently recruiting?
Yes, NCT06380114 is actively recruiting participants. Contact the research team at robin_bender@urmc.rochester.edu for enrollment information.
Where is the NCT06380114 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06380114 clinical trial?
NCT06380114 is sponsored by University of Rochester. The trial plans to enroll 16,000 participants.