HpvNCT06380114
Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination
A study testing Communication and Standing Orders in people with Hpv, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hpv
- What is being tested?
- Communication and Standing Orders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- active patient in AHP practice
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center (URMC)
Rochester, New York, 14642
Robin Bender, LMSW
About this study
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
- Being tested
- Communication, Standing Orders
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunicationBehavioural
Practice personnel (providers and nurses) receive training in communication about HPV vaccination via an online learning module.
Standing OrdersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Communication Training | Active comparator | Practice personnel (providers and nurses) receive training in communication about HPV vaccination. Receives: 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. Receives: Behavioral: Communication; Behavioral: Standing Orders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start4 Nov 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HpvStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Cynthia Rand, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380114
- Sponsor's protocol ID
- STUDY00009296
- Other IDs
- R01CA270276
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with investigators upon request as part of a collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination
- ClinicalTrials.gov ID
- NCT06380114
- Acronym / sponsor ID
- STUDY00009296
- Conditions
- Hpv
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication Training | Active comparator | Behavioral: CommunicationPractice personnel (providers and nurses) receive training in communication about HPV vaccination. |
| Communication Training + Standing Orders Training/Implementation | Experimental | Behavioral: Communication, Behavioral: Standing OrdersPractice personnel (providers and nurses) receive training in communication about HPV vaccination and training in the implementation of standing orders for HPV vaccination. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- active patient in AHP practice
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CommunicationPractice personnel (providers and nurses) receive training in communication about HPV vaccination via an online learning module. | Behavioural | Communication Training, Communication Training + Standing Orders Training/Implementation |
| Standing OrdersPractice 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. | Behavioural | Communication Training + Standing Orders Training/Implementation |
Primary outcome
Patient-Level Captured Opportunities for HPV Vaccination
Time frame: 12-month intervention period
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with investigators upon request as part of a collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication and Standing Orders in people with Hpv, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin Bender ((585) 274-1499, robin_bender@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Level Captured Opportunities for HPV Vaccination (time frame: 12-month intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.