Human Papilloma Virus VaccineNCT06831383
The STOP-HPV Scale Up Study
A study testing STOP-HPV-Online and STOP-HPV-LC in people with Human Papilloma Virus Vaccine, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Human papillomavirus (HPV) causes 35,900 US cancer cases per year, 4,000 deaths, and $4 billion in can In this study, the investigators will conduct a 3-arm clustered randomized controlled trial (RCT) in an estimated 72 practices from up to 8 health systems to evaluate the effectiveness and cost effectiveness of two… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Human Papilloma Virus Vaccine
- What is being tested?
- STOP-HPV-Online and STOP-HPV-LC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to 19 Apr 2027
- 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
- No healthy volunteers
- Child
Who may be able to join
- Patient of participating practice
- Well child care visit during the 12-month intervention period
- No prior dose of HPV vaccine at the time of the well child care visit
- Age-eligible
Who cannot join
- Prior dose of HPV vaccine
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
AMGA
Alexandria, Virginia, 22314
Cindy Shekailo, 703-838-0033 ext. 361, cshekailo@amga.org
About this study
Human papillomavirus (HPV) causes 35,900 US cancer cases per year, 4,000 deaths, and $4 billion in can In this study, the investigators will conduct a 3-arm clustered randomized controlled trial (RCT) in an estimated 72 practices from up to 8 health systems to evaluate the effectiveness and cost effectiveness of two potentially scalable implementation strategies (based on prior work) to increase the initiation of HPV vaccine against a usual care (control) arm. The intervention arms are 1) online provider communication training only ("STOP-HPV-Online" and 2) online provider communication training plus a Learning Collaborative, with performance feedback, attended by practice leads ("STOP-HPV-LC).
cer-related costs. It is recommended at ages 11-12 years routinely but can be given starting at ages 9-10 years. Despite having an effective vaccine, HPV vaccine initiation/completion rates in the U.S. were only at 76.8%/61.4% respectively in 2023 among 13-17 year olds; these rates are lower than the other recommended adolescent vaccines. Two key barriers are 1) suboptimal clinician communication to address parental concerns and 2) ineffective office systems causing missed vaccine opportunities.
Read the detailed description
In prior work, the investigators have tested two implementation strategies/interventions that were effective, but which were deployed by the research team. The first is provider communication training ("STOP-HPV-Online"), delivered by the research team, in a cluster RCT in 48 pediatric practices from a research network (6.8% improvement in initiation). The other is a quality improvement, pre-post study, that included both provider communication training, as well as a Learning Collaborative (LC) for practice leads (8% increase in initiation).
A major challenge in implementation science and spreading practice-based strategies is to move from research teams deploying implementation strategies (intervention) to health systems deploying them. In this study, the investigators will compare the effectiveness and cost-effectiveness of the two implementation strategies (interventions) using a 3-arm clustered RCT: 1) STOP-HPV-Online vs 2) STOP-HPV-LC vs 3) usual care. The study team will randomize an estimated 72 practices (from up to 8 health systems) to the 1) STOP-HPV-Online arm, 2) the STOP-HPV-LC arm or 3) the control arm, assess fidelity to the intervention and conduct the evaluation. A collaborating organization, AMGA (the American Medical Group Association), will facilitate training of the health system personnel, as needed; however, the health systems will deploy each intervention. The primary outcome measure is the initiation rate among 9-<13 year olds with a well-child care visit during the 12 month intervention period (with inclusion starting at the time of a well child care visit during the intervention period). A secondary outcome measure will be the initiation rate among 13-17 year olds with a well child care visit during the intervention period (with inclusion starting at the time of a well child care visit during the intervention period. For both measures, inclusion criteria will be: 1) presenting to a participating practice, 2) age eligible at the visit and 3) no prior vaccine at the time of the visit.
- Conditions
- Human Papilloma Virus Vaccine
- Being tested
- STOP-HPV-Online, STOP-HPV-LC
- Keywords
- Human Papillomavirus Vaccination, Practice-based improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP-HPV-OnlineBehavioural
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-Online intervention.
STOP-HPV-LCBehavioural
Approximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-LC intervention.
| Study group | Role | What they receive |
|---|---|---|
| STOP-HPV Online | Experimental | Provider communication training Receives: Behavioral: STOP-HPV-Online |
| STOP-HPV LC | Experimental | Provider communication training plus Learning Collaborative sessions attended by practice leads and quarterly performance feedback to the practice. Receives: Behavioral: STOP-HPV-LC |
| Usual Care | No intervention | Standard of care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with a participating provider during the intervention period.
The percent of children ages 9-<13 years of age who received their first dose of HPV vaccine at or following a well child care visit with a participating provider during the intervention-period (denominator is children ages 9-<13 with a well child visit during the study period at which they were due for their first dose).
Measured: 12 months from start of intervention
Secondary outcomes (4)
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with a participating provider during the intervention period.
The percent of children ages 13-17 years of age who received their first dose of HPV vaccine at or following a well child care visit with a participating provider during the intervention-period (denominator is children ages 13-17 years with a well child visit during the study period at which they were due for their first dose).
Measured: 12 months from start of intervention
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with any provider during the intervention period.
The percent of children ages 9-<13 years of age who received their first dose of HPV vaccine at or following a well child care visit with any provider (participating or not) during the intervention-period (denominator is children ages 9-<13 with a well child visit during the study period at which they were due for their first dose).
Measured: 12 months from start of intervention
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with any provider during the intervention period.
The percent of children ages 13-17 years of age who received their first dose of HPV vaccine at or following a well child care visit with any provider (participating or not) during the intervention-period (denominator is children ages 13-17 years with a well child visit during the study period at which they were due for their first dose).
Measured: 12 months from start of intervention
Total implementation cost
The difference in costs between arms will be used to calculate the incremental cost-effectiveness ratio (ICER)
Measured: 12 months from start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start30 Mar 2026
- Primary completion19 Apr 2027 (estimated)
- Study completion19 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus VaccineStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Group Association, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
- Investigators
- Peter Szilagyi, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831383
- Sponsor's protocol ID
- 23-000022
- Other IDs
- 1R01CA276151-01
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2025
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STOP-HPV Scale Up Study
- ClinicalTrials.gov ID
- NCT06831383
- Acronym / sponsor ID
- 23-000022
- Conditions
- Human Papilloma Virus Vaccine
- Keywords
- Human Papillomavirus Vaccination, Practice-based improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- American Medical Group Association, National Cancer Institute (NCI)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 19 Apr 2027 (estimated)
- Study completion
- 19 Apr 2027 (estimated)
- First posted
- 18 Feb 2025 (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.
Human papillomavirus (HPV) causes 35,900 US cancer cases per year, 4,000 deaths, and $4 billion in can In this study, the investigators will conduct a 3-arm clustered randomized controlled trial (RCT) in an estimated 72 practices from up to 8 health systems to evaluate the effectiveness and cost effectiveness of two potentially scalable implementation strategies (based on prior work) to increase the initiation of HPV vaccine against a usual care (control) arm. The intervention arms are 1) online provider communication training only ("STOP-HPV-Online" and 2) online provider communication training plus a Learning Collaborative, with performance feedback, attended by practice leads ("STOP-HPV-LC).
cer-related costs. It is recommended at ages 11-12 years routinely but can be given starting at ages 9-10 years. Despite having an effective vaccine, HPV vaccine initiation/completion rates in the U.S. were only at 76.8%/61.4% respectively in 2023 among 13-17 year olds; these rates are lower than the other recommended adolescent vaccines. Two key barriers are 1) suboptimal clinician communication to address parental concerns and 2) ineffective office systems causing missed vaccine opportunities.
Detailed description
In prior work, the investigators have tested two implementation strategies/interventions that were effective, but which were deployed by the research team. The first is provider communication training ("STOP-HPV-Online"), delivered by the research team, in a cluster RCT in 48 pediatric practices from a research network (6.8% improvement in initiation). The other is a quality improvement, pre-post study, that included both provider communication training, as well as a Learning Collaborative (LC) for practice leads (8% increase in initiation).
A major challenge in implementation science and spreading practice-based strategies is to move from research teams deploying implementation strategies (intervention) to health systems deploying them. In this study, the investigators will compare the effectiveness and cost-effectiveness of the two implementation strategies (interventions) using a 3-arm clustered RCT: 1) STOP-HPV-Online vs 2) STOP-HPV-LC vs 3) usual care. The study team will randomize an estimated 72 practices (from up to 8 health systems) to the 1) STOP-HPV-Online arm, 2) the STOP-HPV-LC arm or 3) the control arm, assess fidelity to the intervention and conduct the evaluation. A collaborating organization, AMGA (the American Medical Group Association), will facilitate training of the health system personnel, as needed; however, the health systems will deploy each intervention. The primary outcome measure is the initiation rate among 9-<13 year olds with a well-child care visit during the 12 month intervention period (with inclusion starting at the time of a well child care visit during the intervention period). A secondary outcome measure will be the initiation rate among 13-17 year olds with a well child care visit during the intervention period (with inclusion starting at the time of a well child care visit during the intervention period. For both measures, inclusion criteria will be: 1) presenting to a participating practice, 2) age eligible at the visit and 3) no prior vaccine at the time of the visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STOP-HPV Online | Experimental | Behavioral: STOP-HPV-OnlineProvider communication training |
| STOP-HPV LC | Experimental | Behavioral: STOP-HPV-LCProvider communication training plus Learning Collaborative sessions attended by practice leads and quarterly performance feedback to the practice. |
| Usual Care | No intervention | –Standard of care control |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient of participating practice
- Well child care visit during the 12-month intervention period
- No prior dose of HPV vaccine at the time of the well child care visit
- Age-eligible
Key exclusion criteria (1 listed)
- Prior dose of HPV vaccine
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 |
|---|---|---|
| STOP-HPV-OnlineApproximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-Online intervention. | Behavioural | STOP-HPV Online |
| STOP-HPV-LCApproximately one third of practices within a participating health system will be randomized to receiving the STOP-HPV-LC intervention. | Behavioural | STOP-HPV LC |
Primary outcome
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with a participating provider during the intervention period.
Time frame: 12 months from start of intervention
The percent of children ages 9-<13 years of age who received their first dose of HPV vaccine at or following a well child care visit with a participating provider during the intervention-period (denominator is children ages 9-<13 with a well child visit during the study period at which they were due for their first dose).
4 secondary outcomes
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with a participating provider during the intervention period.
Time frame: 12 months from start of intervention
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with any provider during the intervention period.
Time frame: 12 months from start of intervention
Initiation (first dose) of HPV vaccination among 13-17 year olds at or following a well care visit with any provider during the intervention period.
Time frame: 12 months from start of intervention
Total implementation cost
Time frame: 12 months from start of intervention
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 19 May 2026.
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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.
Peter Szilagyi, MD, MPH principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOP-HPV-Online and STOP-HPV-LC in people with Human Papilloma Virus Vaccine, run by University of California, Los Angeles 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 4 inclusion and 1 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 19 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 Peter Szilagyi, MD, MPH (310-206-6328, pszilagyi@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation (first dose) of HPV vaccination among 9-<13 year olds at or following a well care visit with a participating provider during the intervention period. (time frame: 12 months from start of intervention). 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 19 May 2026.