- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07412743
Multilevel Peer-to-Peer HPV Vaccination and Wellness Educational Program in School Based Health Centers (PEER)
April 24, 2026 updated by: Kaiser Permanente
School-based health centers (SBHCs) are an important setting to improve health through detecting, managing and preventing chronic illness.
Too few people are educated about the human papillomavirus (HPV), which can prevent tens of thousands of deaths from cancer each year.
PEER will evaluate a program to increase health and wellness and the use of SBHCs for primary and preventive care.
If successful, PEER could significantly increase the use of SBHCs, and decrease HPV-associated cancers and, thus, reduce the burden of cancer in the United States.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
4000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Kaiser Permanente Center for Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 9-18
- New or established patients
- Flagged if due for an HPV vaccine
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control time (pre-implementation)
All participating SBHCs offer routine HPV vaccination recommendations as part of clinical care and SBHC staff will continue to follow standard procedures to deliver these services.
Further, all SBHCs have existing relationships with the affiliated schools, so the delivery of these healthcare services in the context of schools will not deviate from usual care.
|
|
|
Experimental: Intervention (post-implementation)
Intervention components (mailers, provider materials, and peer-to-peer educational sessions) will be administered during the intervention portion of each cluster.
|
Letter and fact sheet (infographic) mailed to caregivers of 9-14 year-olds and to teens 15-18, with optional phone call for "confidential patients" aged 15-18.
Clinic team/staff training based on qualitative interviews, recommended strategies and evidence-based interventions.
Training materials include FAQs and Smart phrases.
FAQs and informational sheets containing the same content as the mailers distributed in clinic to teen SBHC patients and their caregivers.
Educational sessions delivered in schools by OSBHA interns.
Session content includes SBHC information and HPV awareness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Vaccination for HPV (n of patients with HPV vaccination/n of patients eligible for vaccination)
Time Frame: 6 and 12 months
|
Vaccination among eligible clinic patients, and time to vaccination
|
6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rates of new patients to the clinic (n of new patients/n of established patients)
Time Frame: 6 and 12 months
|
New patients seen (vs.
prior seen pts.) - New patient characteristics (age, rural)
|
6 and 12 months
|
|
Rate of use of other SBHC services (primary care visits, wellness assessments) (n of patients with primary care visits/n of new and established patients)
Time Frame: 6 and 12 months
|
Use of other SBHC services and visits among eligible clinic patients
|
6 and 12 months
|
|
Rate of vaccination for other adolescent vaccinations (COVID-19, flu, Meningitis, or uptick of other vax's (TDAP, MMR, etc.)) (n of patients with additional vaccination among new and eligible clinic patients)
Time Frame: 6 and 12 months
|
Vaccination among eligible clinic patients, and time to vaccination
|
6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda Petrik, PhD, Kaiser Permanente
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
June 1, 2029
Study Registration Dates
First Submitted
February 6, 2026
First Submitted That Met QC Criteria
February 13, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 24, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- R01MD019038-01A1 (U.S. NIH Grant/Contract)
- R01MD019038 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Deidentified data and accompanying data dictionaries will be stored for future sharing as anonymized data sets in a data repository per NIH data sharing requirements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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