Recruiting

HPV Vaccination

Sponsor:

University of Rochester

Code:

NCT06380114

Conditions

Hpv

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

Interventions

Communication

Standing Orders

Study Details

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 ID

NCT06380114

Start date

Nov 4, 2024

Status verified date

Apr, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

16000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Communication Training

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

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.

Interventions

Communication

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

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.

Primary outcome measure

  • Patient-Level Captured Opportunities for HPV Vaccination [ Time Frame: 12-month intervention period ]

Central Contacts and Locations

Locations

University of Rochester Medical Center (URMC)

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University of Rochester

Last update posted

May 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-05-29.