Human Papilloma VirusNCT05742386
Impact of Standing Orders Optimization
A study testing Communication training and Communication training enhanced with standing orders optimization in people with Human Papilloma Virus, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Communication training and Communication training enhanced with standing orders optimization
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 31 Dec 2026
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinics are eligible if they:
- provide HPV vaccine to children ages 9-12
- have standing orders for HPV vaccination approved but not routinely used or be willing to adopt them prior to the start of the trial
- have rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined
- Children's medical records will be eligible to be included in the dataset if children:
- are between the ages of 9-12 years at baseline
- are attributed to a participating clinic at 12- or 24-month follow-up
- Clinical staff's survey data will be eligible to be included in the dataset if clinical staff complete the follow-up survey.
Who cannot join
- Clinics are excluded if they:
- do not provide HPV vaccine to children ages 9-12
- do not have standing orders for HPV vaccination or are not willing to adopt them prior to the start of the trial
- have rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined
- have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings
- have quality improvement efforts to change HPV vaccine standing orders during the trial
Show all 11Show fewer
- Children's medical records will not be eligible to be included in the dataset if children:
- are not between the ages of 9-12 years at baseline
- are not attributed to a participating clinic at 12- or 24-month follow-up
- are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications
- Clinical staff's survey data will be not eligible to be included in the dataset if clinical staff do not complete the follow-up survey.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Evaluating the Impact of Optimizing the Use of HPV Vaccine Standing Orders in Primary Care Clinics
This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders.
Read the detailed description
The researchers will conduct a cluster randomized clinical trial. The trial will look at the impact of optimizing HPV vaccine standing orders. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive a communication training. Other clinics will receive a communication training and tools for optimizing the use of their standing orders. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The researchers will also use survey data to compare HPV vaccine communication and implementation of standing orders among clinical staff. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
- Conditions
- Human Papilloma Virus
- Being tested
- Communication training, Communication training enhanced with standing orders optimization
- Keywords
- Human Papilloma Virus, Pediatric medicine, Primary care, Standing orders, Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication trainingBehavioural
Clinics will host an AAT workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own.
Communication training enhanced with standing orders optimizationBehavioural
Clinics will host an AAT workshop, as in the other trial arm.
Clinic representatives will attend working meetings on putting HPV vaccine standing orders into clinic workflow. Clinics will then orient their staff to the standing orders. Finally, clinic representatives will discuss their use of standing orders in a learning collaborative.
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccine communication training | Experimental | Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination. Receives: Behavioral: Communication training |
| HPV vaccine communication training and standing orders optimization | Experimental | Staff in clinics randomized to this arm will receive the AAT and conduct a set of activities to optimize use of HPV vaccine standing orders. Receives: Behavioral: Communication training enhanced with standing orders optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination (≥1 dose), 9-12 year olds
Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
Measured: from baseline to 12 months
Secondary outcomes (19)
HPV vaccination (≥1 dose), 9-12 year olds
Proportion of unvaccinated children who initiate the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
Measured: from 13 months to 24 months
HPV vaccination (≥2 doses), 9-12 year olds
Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
Measured: from baseline to 12 months
HPV vaccination (≥2 doses), 9-12 year olds
Proportion of unvaccinated children who complete the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
Measured: from 13 months to 24 months
Standing orders attitude rating
Positive attitude toward using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive attitudes.
Measured: up to 6 months
Standing orders norms rating
Norms in favor of using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.
Measured: up to 6 months
Standing orders self-efficacy rating
Confidence about using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher confidence.
Measured: up to 6 months
Standing orders adoption rating
Adoption of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater adoption.
Measured: up to 6 months
Standing orders acceptability rating
Acceptability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher acceptability.
Measured: up to 6 months
Standing orders appropriateness rating
Appropriateness of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater appropriateness.
Measured: up to 6 months
Standing orders role rating
Understanding of role under HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating better understanding of role.
Measured: up to 6 months
Standing orders feasibility rating
Feasibility of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater feasibility.
Measured: up to 6 months
Standing orders sustainability rating
Sustainability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater sustainability.
Measured: up to 6 months
Estimated time spent on recommendations
Time spent on HPV vaccine recommendations will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 0-99 minutes, with higher values indicating more time spent.
Measured: up to 6 months
Estimated recommendation frequency, 9-10 year olds
Frequency of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.
Measured: up to 6 months
Estimated recommendation frequency, 11-12 year olds
Frequency of recommending HPV vaccine for children ages 11 or 12 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.
Measured: up to 6 months
Recommendation attitudes rating
Positive attitudes toward recommending HPV vaccine for ages children ages 9 or 10 years will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive recommendation attitudes.
Measured: up to 6 months
Recommendation self-efficacy rating
Confidence in recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher recommendation confidence.
Measured: up to 6 months
Recommendation norms rating
Norms in favor of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.
Measured: up to 6 months
Recommendation intentions rating
Intentions to recommend HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT The range for this measure will be 1 to 5, with higher values indicating higher recommendation intentions.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start22 Feb 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Model description
- Cluster randomized design in which clinics will be randomized
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Noel T Brewer, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742386
- Sponsor's protocol ID
- IMPACTP1SO
- Other IDs
- 5P01CA250989-02
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Optimizing the Use of HPV Vaccine Standing Orders in Primary Care Clinics
- ClinicalTrials.gov ID
- NCT05742386
- Acronym / sponsor ID
- IMPACTP1SO
- Conditions
- Human Papilloma Virus
- Keywords
- Human Papilloma Virus, Pediatric medicine, Primary care, Standing orders, Vaccination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2023 (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.
This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders.
Detailed description
The researchers will conduct a cluster randomized clinical trial. The trial will look at the impact of optimizing HPV vaccine standing orders. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive a communication training. Other clinics will receive a communication training and tools for optimizing the use of their standing orders. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The researchers will also use survey data to compare HPV vaccine communication and implementation of standing orders among clinical staff. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized design in which clinics will be randomized
| Arm | Type | Receives |
|---|---|---|
| HPV vaccine communication training | Experimental | Behavioral: Communication trainingStaff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination. |
| HPV vaccine communication training and standing orders optimization | Experimental | Behavioral: Communication training enhanced with standing orders optimizationStaff in clinics randomized to this arm will receive the AAT and conduct a set of activities to optimize use of HPV vaccine standing orders. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- provide HPV vaccine to children ages 9-12
- have standing orders for HPV vaccination approved but not routinely used or be willing to adopt them prior to the start of the trial
- have rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined
- are between the ages of 9-12 years at baseline
- are attributed to a participating clinic at 12- or 24-month follow-up
Key exclusion criteria (11 listed)
- do not provide HPV vaccine to children ages 9-12
- do not have standing orders for HPV vaccination or are not willing to adopt them prior to the start of the trial
- have rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined
- have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings
- have quality improvement efforts to change HPV vaccine standing orders during the trial
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 |
|---|---|---|
| Communication trainingClinics will host an AAT workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own. | Behavioural | HPV vaccine communication training |
| Communication training enhanced with standing orders optimizationClinics will host an AAT workshop, as in the other trial arm. Clinic representatives will attend working meetings on putting HPV vaccine standing orders into clinic workflow. Clinics will then orient their staff to the standing orders. Finally, clinic representatives will discuss their use of standing orders in a learning collaborative. | Behavioural | HPV vaccine communication training and standing orders optimization |
Primary outcome
HPV vaccination (≥1 dose), 9-12 year olds
Time frame: from baseline to 12 months
Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
19 secondary outcomes
HPV vaccination (≥1 dose), 9-12 year olds
Time frame: from 13 months to 24 months
HPV vaccination (≥2 doses), 9-12 year olds
Time frame: from baseline to 12 months
HPV vaccination (≥2 doses), 9-12 year olds
Time frame: from 13 months to 24 months
Standing orders attitude rating
Time frame: up to 6 months
Standing orders norms rating
Time frame: up to 6 months
Standing orders self-efficacy rating
Time frame: up to 6 months
Standing orders adoption rating
Time frame: up to 6 months
Standing orders acceptability rating
Time frame: up to 6 months
Standing orders appropriateness rating
Time frame: up to 6 months
Standing orders role rating
Time frame: up to 6 months
Standing orders feasibility rating
Time frame: up to 6 months
Standing orders sustainability rating
Time frame: up to 6 months
Estimated time spent on recommendations
Time frame: up to 6 months
Estimated recommendation frequency, 9-10 year olds
Time frame: up to 6 months
Estimated recommendation frequency, 11-12 year olds
Time frame: up to 6 months
Recommendation attitudes rating
Time frame: up to 6 months
Recommendation self-efficacy rating
Time frame: up to 6 months
Recommendation norms rating
Time frame: up to 6 months
Recommendation intentions rating
Time frame: up to 6 months
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 21 Apr 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
Recruiting
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
HPV Vaccination
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia
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. This study is not recruiting at the moment.
Noel T Brewer, PhD principal investigator
University of North Carolina
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 training and Communication training enhanced with standing orders optimization in people with Human Papilloma Virus, run by UNC Lineberger Comprehensive Cancer Center 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination (≥1 dose), 9-12 year olds (time frame: from baseline to 12 months). 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 21 Apr 2026.