Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

NCT ID: NCT06380114

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2027-11-30

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.

Conditions

Hpv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Communication Training

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

Group Type: ACTIVE_COMPARATOR

Communication

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Communication

Intervention Type: BEHAVIORAL

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

Standing Orders

Intervention Type: BEHAVIORAL

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.

Interventions

Communication

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

Intervention Type: BEHAVIORAL

Standing 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Rand

Professor, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center (URMC)

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robin Bender

Role: CONTACT

robin_bender@urmc.rochester.edu

(585) 274-1499

Facility Contacts

Robin Bender, LMSW

Role: primary

Other Identifiers

R01CA270276

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009296

Identifier Type: -

Identifier Source: org_study_id