Human Papillomavirus VaccinesNCT04180462
Increasing Optimal Use of HPV Vaccination in Primary Care
A study testing Practice Facilitation, Education and Audit and Feedback in people with Human Papillomavirus Vaccines, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines
- What is being tested?
- Practice Facilitation, Education and Audit and Feedback
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2020to 29 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practices:
- Community-based pediatric primary care practices with 2 or more providers.
- Providers who deliver wellness care to preteens and adolescents.
- Willingness to participate in the practice facilitator-guided QI process.
- Providers:
- Providers who deliver wellness care to preteens and adolescents.
- Willingness to complete study questionnaires.
- Willingness to participate in the practice facilitator-guided QI process.
Who cannot join
- Practices and providers may be excluded at the discretion of the PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care
Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.
Read the detailed description
The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation.
The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.
- Conditions
- Human Papillomavirus Vaccines
- Being tested
- Practice Facilitation, Education, Audit and Feedback, Communication Strategy
- Keywords
- Implementation Strategy, Quality Improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice FacilitationOther
Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.
EducationOther
An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.
Audit and FeedbackOther
Audit and feedback of vaccine coverage to increase motivation to engage in practice change.
Communication StrategyOther
A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Practices randomly assigned to this arm will receive the multi-component intervention. Receives: Other: Practice Facilitation; Other: Education; Other: Audit and Feedback; Other: Communication Strategy |
| Wait list control group | No intervention | Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of the HPV Vaccine 2-dose Series.
The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Measured: 24 months
Completion of the HPV Vaccine 2-dose Series.
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.
Measured: 24 months
Secondary outcomes (2)
Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.
The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization
Measured: 36 months
Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start7 Jan 2020
- Primary completion14 Feb 2023
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus VaccinesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Allison King, M.D., Ph.D., MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180462
- Sponsor's protocol ID
- 201911030
- Other IDs
- 1R01CA235615-01A1
- Status last verified
- Mar 2025
- First submitted
- 26 Nov 2019
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang R, Liu L, Dodd S, Graham S, Rook S, Ericson L, Plax K, Barker A, McKay V, Silver MI, Newland JG, King AA. A Multicomponent Strategy to Increase Human Papillomavirus Vaccination Rates in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e260049. doi: 10.1001/jamanetworkopen.2026.0049.
PubMed 41746648
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care
- ClinicalTrials.gov ID
- NCT04180462
- Acronym / sponsor ID
- 201911030
- Conditions
- Human Papillomavirus Vaccines
- Keywords
- Implementation Strategy, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.
Detailed description
The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation.
The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Practice Facilitation, Other: Education, Other: Audit and Feedback, Other: Communication StrategyPractices randomly assigned to this arm will receive the multi-component intervention. |
| Wait list control group | No intervention | –Practices randomly assigned to this arm will be offered the intervention in the last two years of the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Community-based pediatric primary care practices with 2 or more providers.
- Providers who deliver wellness care to preteens and adolescents.
- Willingness to participate in the practice facilitator-guided QI process.
- Providers who deliver wellness care to preteens and adolescents.
- Willingness to complete study questionnaires.
Key exclusion criteria (1 listed)
- Practices and providers may be excluded at the discretion of the PI.
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 |
|---|---|---|
| Practice FacilitationPractice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system. | Other | Intervention Group |
| EducationAn educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13. | Other | Intervention Group |
| Audit and FeedbackAudit and feedback of vaccine coverage to increase motivation to engage in practice change. | Other | Intervention Group |
| Communication StrategyA communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation. | Other | Intervention Group |
Primary outcome
Initiation of the HPV Vaccine 2-dose Series.
Time frame: 24 months
The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Completion of the HPV Vaccine 2-dose Series.
Time frame: 24 months
The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.
2 secondary outcomes
Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.
Time frame: 36 months
Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41746648Wang R, Liu L, Dodd S, Graham S, Rook S, Ericson L, Plax K, Barker A, McKay V, Silver MI, Newland JG, King AA. A Multicomponent Strategy to Increase Human Papillomavirus Vaccination Rates in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e260049. doi: 10.1001/jamanetworkopen.2026.0049.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Washington University: Pediatric \& Adolescent Ambulatory Research ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Allison King, M.D., Ph.D., MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Facilitation, Education and Audit and Feedback in people with Human Papillomavirus Vaccines, run by Washington University School of Medicine 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 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: finished, as of the sponsor's last update on 25 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Initiation of the HPV Vaccine 2-dose Series. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180462, which also lists 1 linked publication.
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 25 Mar 2025.