Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

NCT06380114 | Recruiting

• 2 other identifiers: STUDY00009296R01CA270276
• Study Type: interventional
• Target: 16,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  12-month baseline compared to 12-month intervention compared to 12-month maintenance (control arm vs intervention arm)

Study Arms (2)

Communication Training

ACTIVE COMPARATOR

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

Behavioral: Communication

Communication Training + Standing Orders Training/Implementation

EXPERIMENTAL

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

Communication BEHAVIORAL

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

Communication Training; Communication Training + Standing Orders Training/Implementation

Standing Orders 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.

Communication Training + Standing Orders Training/Implementation

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• active patient in AHP practice

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester Medical Center (URMC)

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Standing Orders

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Protocols; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Robin Bender

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)