Papillomavirus VaccinesNCT03501992

Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination

A study testing Current care, Reminder-recall and Audit-and-feedback in people with Papillomavirus Vaccines, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 to 12 years
Conditions the study is for: Papillomavirus Vaccines
What is being tested?: Current care, Reminder-recall and Audit-and-feedback
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9,242 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2018to 1 Sep 2023
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 11 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Empaneled in one of the six participating primary care practices
11 to 12 years of age at the first day of each of the 12-month-long steps
Due during that 12-month-long step for at least one dose of the HPV vaccine

Who cannot join

Not empaneled in one of the six participating practices
Empaneled in one of the six participating practices but less than 11 years of age or more than 12 years of age on the first day of each 12 month long step
Not due during that 12-month-long step for a dose of HPV vaccine.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"--Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination

Each year the human papillomavirus (HPV) causes 30,000 cancers in the United States despite the availability of very effective and safe vaccines. Uptake of the HPV vaccine has been disappointingly low and lags behind other adolescent vaccines. This study seeks to test interventions targeting health care system, provider, and patient factors to improve the population uptake of the HPV vaccine.

Read the detailed description

The broad, long-term objective is to substantially increase human papillomavirus (HPV) vaccination rates by deploying effective population-health interventions in clinical practices across the United States. As part of this effort, the investigators intend to evaluate two evidence-based interventions with innovative enhancements at six Mayo Clinic primary care practices (PCP) to evaluate their individual and combined impact on rates of HPV vaccination among female and male patients. Aim 1, "Less Pain, Less Fuss, Right Now!", will test the hypothesis that, as compared to no intervention (current practice), a practice-level intervention utilizing reminder-recalls featuring the availability of non-medication and medication anesthetics, the convenience of nurse-only visits, and the use of persuasive language for early, on-time vaccinations will improve HPV vaccine delivery rates. Aim 2, "Make It Count!", will test the hypothesis that, as compared to no intervention, a provider level intervention utilizing a missed-opportunities assessment and feedback intervention applying social pressure (specific peer-performance comparisons) and equipping providers with a strong-recommendation toolkit will improve HPV vaccine delivery rates. Aim 3 will test the hypothesis that simultaneous implementation of interventions targeting individual, interpersonal, and organizational factors will have a synergistic effect on HPV vaccine delivery rates. To accomplish Aims 1-3, the investigators will use a stepped-wedge cluster randomized trial with an integrated process evaluation. The cluster approach prevents cross-contamination between patients or providers as we allocate two separate interventions (Aims 1 and 2) in the six PCPs. The stepped-wedge design, which ensures all practices eventually receive the same set of interventions, permits the single institutional review board overseeing all six PCPs to approve the study without requiring recruitment and consent of individual patients or providers. The stepped-wedge approach also permits the investigators to test the presence of each of the interventions in each PCP, making trial participation more attractive, while also allowing each practice to serve as its own control, reducing the bias due to imbalanced risk factors across practices. The factorial design allows the investigators to use a single trial to test two interventions and assess each individually and in combination. The design also conserves sample size while maintaining power. The investigators will measure the impact separately in females and males, 11-12 years of age for the rates of receipt of HPV vaccine doses due. Rigorously tested, highly effective, population-level interventions are essential if the US is to reach the Healthy People 2020 goal for HPV vaccination. The rigor, design, and high likelihood of success of this study will provide key evidence regarding practice- and provider-level interventions to improve HPV vaccination rates. Mayo Clinic's best practices inform not only its own 70 practices across five states but its Mayo Clinic Care Network, which consists of nearly 40 health-care organizations across 26 states and Puerto Rico.

Conditions: Papillomavirus Vaccines
Being tested: Current care, Reminder-recall, Audit-and-feedback, Combined reminder-recall and audit-and-feedback
Keywords: Papillomavirus vaccines, Vaccination, Patient acceptance of health care, Child, Parents, Primary health care, Health personnel, Primary prevention, Neoplasms
Medical subject headings: Patient Acceptance of Health Care, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Current careBehavioural
Also called Active control, active comparator, current practice
The current care arm consists of the contemporary efforts now in practice to support provider recommendation including a shared, standard immunization schedule, a shared rooming process, a shared well child visit schedule, a shared electronic prompt at point-of-care of vaccines due.
Reminder-recallBehavioural
Also called "Less Pain, Less Fuss, Right Now!" reminder-recall
The communication will use expectant (announcement-style or presumptive) language noting the child's HPV vaccination status and stating that the child's provider strongly recommends the child receive the HPV vaccination now. The communication will also describe availability of topical anesthetics (less pain), indicate the availability and convenience of nurse visits for HPV vaccination (less fuss), and describe the immunological and logistical benefits of early vaccination (right now).
Audit-and-feedbackBehavioural
Also called "Make It Count!" audit-and-feedback & provider toolkit
The intervention includes two components. The first is a missed opportunities audit-and-feedback. The second is a provision of a strong recommendation provider-toolkit, along with a broad education of the practice staff-nurses, medical secretaries, receptionists, and clinical assistants-regarding the nature of the intervention, its goals, and its likely impact on the practice. The broad education will be conducted through supervisory communications only to practice staff in practices allocated to the intervention at the beginning of the step.
Combined reminder-recall and audit-and-feedbackBehavioural
Also called "Less Pain, Less Fuss, Right Now!" and "Make It Count!"
The combination reminder-and-audit arm consists of a simultaneous application of the intervention tested in the reminder-recall arm and the intervention tested in the audit-and-feedback arm.

Study groups in NCT03501992
Study group	Role	What they receive
Practice A	Other	Practice A will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice A will be assigned to receive the current care intervention. in the second step, Practice A will be assigned to receive the current care intervention. In the third step, Practice A will receive the reminder-recall intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention. Receives: Behavioral: Current care; Behavioral: Reminder-recall; Behavioral: Combined reminder-recall and audit-and-feedback
Practice B	Other	Practice B will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice B will be assigned to receive the current care intervention. In the second step, Practice B will be assigned to receive the reminder-recall intervention. In the third step, Practice B will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention. Receives: Behavioral: Current care; Behavioral: Reminder-recall; Behavioral: Combined reminder-recall and audit-and-feedback
Practice C	Other	Practice C will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice C will be assigned to receive the current care intervention. In the second step, Practice C will be assigned to receive the audit-and-feedback intervention. In the third step, Practice C will receive the audit-and-feedback intervention. In the fourth step, Practice C will receive the combined reminder-recall and audit-and-feedback intervention. Receives: Behavioral: Current care; Behavioral: Audit-and-feedback; Behavioral: Combined reminder-recall and audit-and-feedback
Practice D	Other	Practice D will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice D will be assigned to receive the current care intervention. In the second step, Practice D will be assigned to receive the current care intervention. In the third step, Practice D will receive the audit-and-feedback intervention. In the fourth step, Practice D will receive the combined reminder-recall and audit-and-feedback intervention. Receives: Behavioral: Current care; Behavioral: Audit-and-feedback; Behavioral: Combined reminder-recall and audit-and-feedback
Practice E	Other	Practice E will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice E will be assigned to receive the current care intervention. In the second step, Practice E will be assigned to receive the reminder-recall intervention. In the third step, Practice E will receive the reminder-recall intervention. In the fourth step, Practice E will receive the combined reminder-recall and audit-and-feedback intervention. Receives: Behavioral: Current care; Behavioral: Reminder-recall; Behavioral: Combined reminder-recall and audit-and-feedback
Practice F	Other	Practice F will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice F will be assigned to receive the current care intervention. In the second step, Practice F will be assigned to receive the audit-and-feedback intervention. In the third step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. Receives: Behavioral: Current care; Behavioral: Audit-and-feedback; Behavioral: Combined reminder-recall and audit-and-feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Human Papillomavirus or HPV-vaccine-dose Receipt
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females in the study step who received the dose of HPV vaccine dose due by the end of the study step.
Measured: The dose had to have been received during the 12-month-long study step.

Secondary outcomes (2)

Initiation
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their first doses of the HPV vaccine series in the study step who received the first dose of HPV vaccine dose due by the end of the study step, thus initiating the HPV vaccine series.
Measured: The initiating dose had to have been received during the 12-month-long study step.
Completion
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their final doses of the HPV vaccine series in the study step who received the final dose of HPV vaccine dose due by the end of the study step, thus completing the HPV vaccine series.
Measured: The final dose had to have been received during the 12-month-long study step.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20181 Sep 2023

First posted18 Apr 2018
Study start1 Apr 2018
Primary completion31 Aug 2022
Study completion1 Sep 2023

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 (3)Papers the sponsor has linked to this study.
Other trials for Papillomavirus VaccinesStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: A factorial, stepped-wedge cluster randomized trial with process evaluation
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 9,242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03501992
Sponsor's protocol ID: 17-010661
Other IDs: R01CA217889
Status last verified: Sep 2024
First submitted: 25 Jan 2018
Last updated: 24 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Finney Rutten LJ, Griffin JM, St Sauver JL, MacLaughlin K, Austin JD, Jenkins G, Herrin J, Jacobson RM. Multilevel Implementation Strategies for Adolescent Human Papillomavirus Vaccine Uptake: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):29-36. doi: 10.1001/jamapediatrics.2023.4932.
PubMed 37983062
Kong WY, Finney Rutten LJ, Herrin J, St Sauver JL, Jenkins GD, Griffin JM, Jacobson RM. Multilevel Intervention and Human Papillomavirus Vaccination Disparities: A Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518895. doi: 10.1001/jamanetworkopen.2025.18895.
PubMed 40622715
Finney Rutten LJ, Radecki Breitkopf C, St Sauver JL, Croghan IT, Jacobson DJ, Wilson PM, Herrin J, Jacobson RM. Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial. Implement Sci. 2018 Jul 13;13(1):96. doi: 10.1186/s13012-018-0778-x.
PubMed 30001723

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
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 recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination

All Papillomavirus Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"--Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination
ClinicalTrials.gov ID: NCT03501992
Acronym / sponsor ID: 17-010661
Conditions: Papillomavirus Vaccines
Keywords: Papillomavirus vaccines, Vaccination, Patient acceptance of health care, Child, Parents, Primary health care, Health personnel, Primary prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 9,242 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Apr 2018 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 18 Apr 2018 (actual)
Results: Posted 24 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 6
Model description: A factorial, stepped-wedge cluster randomized trial with process evaluation

Arm	Type	Receives
Practice A	Other	Behavioral: Current care, Behavioral: Reminder-recall, Behavioral: Combined reminder-recall and audit-and-feedbackPractice A will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice A will be assigned to receive the current care intervention. in the second step, Practice A will be assigned to receive the current care intervention. In the third step, Practice A will receive the reminder-recall intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention.
Practice B	Other	Behavioral: Current care, Behavioral: Reminder-recall, Behavioral: Combined reminder-recall and audit-and-feedbackPractice B will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice B will be assigned to receive the current care intervention. In the second step, Practice B will be assigned to receive the reminder-recall intervention. In the third step, Practice B will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention.
Practice C	Other	Behavioral: Current care, Behavioral: Audit-and-feedback, Behavioral: Combined reminder-recall and audit-and-feedbackPractice C will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice C will be assigned to receive the current care intervention. In the second step, Practice C will be assigned to receive the audit-and-feedback intervention. In the third step, Practice C will receive the audit-and-feedback intervention. In the fourth step, Practice C will receive the combined reminder-recall and audit-and-feedback intervention.
Practice D	Other	Behavioral: Current care, Behavioral: Audit-and-feedback, Behavioral: Combined reminder-recall and audit-and-feedbackPractice D will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice D will be assigned to receive the current care intervention. In the second step, Practice D will be assigned to receive the current care intervention. In the third step, Practice D will receive the audit-and-feedback intervention. In the fourth step, Practice D will receive the combined reminder-recall and audit-and-feedback intervention.
Practice E	Other	Behavioral: Current care, Behavioral: Reminder-recall, Behavioral: Combined reminder-recall and audit-and-feedbackPractice E will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice E will be assigned to receive the current care intervention. In the second step, Practice E will be assigned to receive the reminder-recall intervention. In the third step, Practice E will receive the reminder-recall intervention. In the fourth step, Practice E will receive the combined reminder-recall and audit-and-feedback intervention.
Practice F	Other	Behavioral: Current care, Behavioral: Audit-and-feedback, Behavioral: Combined reminder-recall and audit-and-feedbackPractice F will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice F will be assigned to receive the current care intervention. In the second step, Practice F will be assigned to receive the audit-and-feedback intervention. In the third step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention.

Who may qualify

Ages: 11 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Empaneled in one of the six participating primary care practices
11 to 12 years of age at the first day of each of the 12-month-long steps
Due during that 12-month-long step for at least one dose of the HPV vaccine

Key exclusion criteria (3 listed)

Not empaneled in one of the six participating practices
Empaneled in one of the six participating practices but less than 11 years of age or more than 12 years of age on the first day of each 12 month long step
Not due during that 12-month-long step for a 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
Current careAlso: Active control, active comparator, current practiceThe current care arm consists of the contemporary efforts now in practice to support provider recommendation including a shared, standard immunization schedule, a shared rooming process, a shared well child visit schedule, a shared electronic prompt at point-of-care of vaccines due.	Behavioural	Practice A, Practice B, Practice C, Practice D, Practice E, Practice F
Reminder-recallAlso: "Less Pain, Less Fuss, Right Now!" reminder-recallThe communication will use expectant (announcement-style or presumptive) language noting the child's HPV vaccination status and stating that the child's provider strongly recommends the child receive the HPV vaccination now. The communication will also describe availability of topical anesthetics (less pain), indicate the availability and convenience of nurse visits for HPV vaccination (less fuss), and describe the immunological and logistical benefits of early vaccination (right now).	Behavioural	Practice A, Practice B, Practice E
Audit-and-feedbackAlso: "Make It Count!" audit-and-feedback & provider toolkitThe intervention includes two components. The first is a missed opportunities audit-and-feedback. The second is a provision of a strong recommendation provider-toolkit, along with a broad education of the practice staff-nurses, medical secretaries, receptionists, and clinical assistants-regarding the nature of the intervention, its goals, and its likely impact on the practice. The broad education will be conducted through supervisory communications only to practice staff in practices allocated to the intervention at the beginning of the step.	Behavioural	Practice C, Practice D, Practice F
Combined reminder-recall and audit-and-feedbackAlso: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"The combination reminder-and-audit arm consists of a simultaneous application of the intervention tested in the reminder-recall arm and the intervention tested in the audit-and-feedback arm.	Behavioural	Practice A, Practice B, Practice C, Practice D, Practice E, Practice F

Primary outcome

Human Papillomavirus or HPV-vaccine-dose Receipt
Time frame: The dose had to have been received during the 12-month-long study step.
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females in the study step who received the dose of HPV vaccine dose due by the end of the study step.

2 secondary outcomes

Initiation
Time frame: The initiating dose had to have been received during the 12-month-long study step.
Completion
Time frame: The final dose had to have been received during the 12-month-long study step.

Results and safety

Results posted to the registry on 24 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Practice A	848	848
Practice B	228	228
Practice C	479	479
Practice D	320	320
Practice E	414	414
Practice F	265	265

Primary outcome: Human Papillomavirus or HPV-vaccine-dose Receipt

Time frame: The dose had to have been received during the 12-month-long study step.. Count of participants. Unit: Participants

Measure	Usual Care n = 3572	Parent Reminder-Recall Letter n = 1670	Provider Audit-Feedback Intervention. n = 1340	Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions n = 2660
Value	782	578	408	1056

Population analysed: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males and females in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of participants analyzed for the Usual Care Arm/Group, which is 3572.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable as no adverse events were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Usual Care	0 of 0	0 of 0
Provider Audit-Feedback Intervention.	0 of 0	0 of 0
Parent Reminder-Recall Letter	0 of 0	0 of 0
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions	0 of 0	0 of 0

Limitations and caveats (from the sponsor): As a result of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or COVID-19 pandemic, routine clinical care for the 6 practices was interrupted from the end of March 2020 through August 31, 2020. For that reason, we did not begin Step 3 until September 1, 2020. Because Human Papillomavirus vaccination is highly seasonal among adolescents, Step 3 and Step 4 remained 12 months in duration. Step 3 ended August 31, 2021, and Step 4 began September 1, 2021, and ended August 31, 2022.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37983062Finney Rutten LJ, Griffin JM, St Sauver JL, MacLaughlin K, Austin JD, Jenkins G, Herrin J, Jacobson RM. Multilevel Implementation Strategies for Adolescent Human Papillomavirus Vaccine Uptake: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):29-36. doi: 10.1001/jamapediatrics.2023.4932.
Derived from this study: PubMed 40622715Kong WY, Finney Rutten LJ, Herrin J, St Sauver JL, Jenkins GD, Griffin JM, Jacobson RM. Multilevel Intervention and Human Papillomavirus Vaccination Disparities: A Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518895. doi: 10.1001/jamanetworkopen.2025.18895.
Derived from this study: PubMed 30001723Finney Rutten LJ, Radecki Breitkopf C, St Sauver JL, Croghan IT, Jacobson DJ, Wilson PM, Herrin J, Jacobson RM. Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial. Implement Sci. 2018 Jul 13;13(1):96. doi: 10.1186/s13012-018-0778-x.
Individual participant dataSharing planned: No

Related trials for Papillomavirus Vaccines

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
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Active, not recruitingPhase 3
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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.

Robert M Jacobson, MD principal investigator

Mayo Clinic

Joan M Griffin, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Current care, Reminder-recall and Audit-and-feedback in people with Papillomavirus Vaccines, run by Mayo Clinic 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 3 inclusion and 3 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 24 Oct 2024. 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 24 Oct 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?

Human Papillomavirus or HPV-vaccine-dose Receipt (time frame: The dose had to have been received during the 12-month-long study step.). 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 NCT03501992, which also lists 3 linked publications.

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 24 Oct 2024.