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RecruitingNCT06380114Updated May 29, 2026

Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

An interventional study of Communication and Standing Orders in Hpv, sponsored by University of Rochester. Recruiting at 1 site in United States. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by University of Rochester · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
16,000
Allocation
Randomized
Ages
9 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hpv
03

In context

Papillomavirus Infections

495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's planned enrollment of 16,000 is above the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • active patient in AHP practice

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16,000 participants (estimated)

Study arms

  • Active comparator
    Communication Training

    Practice personnel (providers and nurses) receive training in communication about HPV vaccination.

    Behavioral: Communication

  • Experimental
    Communication Training + Standing Orders Training/Implementation

    Practice personnel (providers and nurses) receive training in communication about HPV vaccination and training in the implementation of standing orders for HPV vaccination.

    Behavioral: Communication · Behavioral: Standing Orders

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.

06

What researchers measure

Primary outcomes

  1. Patient-Level Captured Opportunities for HPV Vaccination

    The percentage of HPV vaccine eligible patients, aged 9-17, with a practice visit during the specified timeframe of interest who receive \>=1 HPV vaccination.

    Time frame: 12-month intervention period

07

Study locations

1 of 1 sites recruiting
  • University of Rochester Medical Center (URMC)
    Rochester, New York 14642, United States
    • Robin Bender, LMSW · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be shared with investigators upon request as part of a collaboration.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380114
Lead sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Responsible party
Cynthia Rand (Professor, Pediatrics, University of Rochester) — Principal investigator
First posted
Apr 23, 2024
Start date
Nov 4, 2024
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
May 29, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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