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NCT06380114 · ClinicalTrials.gov registry record · NA
Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination
A NA study of Hpv, sponsored by University of Rochester.
- Recruiting
- Registry status
- NA
- Development phase
- 16,000
- Enrollment target
- 1
- Study location
NCT06380114: Recruiting NA study of Hpv, sponsored by University of Rochester.
NCT06380114 is a NA study of Hpv that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 16,000 participants, above the 1,575-participant average among 24 other Hpv trials with a reported enrollment target (916% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06380114, a NA study of Hpv, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- NA
- Development phase
- 16,000 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Communication
- BEHAVIORAL Standing Orders
Study Locations (1)
New York
- University of Rochester Medical Center (URMC) - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16,000 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2027-11 |
| Phase | NA |
What NCT06380114 shows while recruiting
NCT06380114 is an interventional study that assigns participants to a tested intervention. Its 16,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,575-participant average among 24 other Hpv trials with a reported enrollment target (916% higher).
The record links to 1 condition, with Hpv appearing as the primary indexed condition, and to 2 interventions - of which Communication is the first listed.
NCT06380114 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06380114 about?
NCT06380114 is a clinical study titled "Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination". 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 vac...
What is the current status of trial NCT06380114?
This trial is currently recruiting. It is a NA study. The enrollment target is 16,000 participants. The study started on 2024-11-04. Estimated completion is 2027-11.
What conditions does trial NCT06380114 study?
This clinical trial studies the following conditions: Hpv.
What interventions are being tested in trial NCT06380114?
The interventions under investigation include: Communication (BEHAVIORAL), Standing Orders (BEHAVIORAL).
Who is sponsoring clinical trial NCT06380114?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06380114 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06380114's enrollment target sits among peer trials
16,000 2nd of 24 the highest of 24 other Hpv trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hpv trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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