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Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06380114
Enrollment
16000
Registered
2024-04-23
Start date
2024-11-04
Completion date
2028-05-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hpv

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.

Interventions

BEHAVIORALCommunication

Practice personnel (providers and nurses) receive training in communication about HPV vaccination via an online learning module.

BEHAVIORALStanding Orders

Practice personnel (providers and nurses) receive training in the implementation of standing orders for HPV vaccination via an online learning module and meetings with the study team.

Sponsors

University of Rochester
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient-Level Captured Opportunities for HPV Vaccination12-month intervention periodThe percentage of HPV vaccine eligible patients, aged 9-17, with a practice visit during the specified timeframe of interest who receive \>=1 HPV vaccination.

Countries

United States

Contacts

CONTACTRobin Bender
robin_bender@urmc.rochester.edu(585) 274-1499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026