A Study to Enhance Provider Recommendations for HPV Vaccination

Overview

About this study

The purpose of this study is to examine the impact on HPV rates in the overall clinical practice before and after the practices changes have been implemented based on the focus groups from prior protocols.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Parents (of children meeting the following inclusion/exclusion criteria) will be sent surveys.  Per IRB, "To encompass all the participants, the age range should reflect the minimum age of 11 years of age and no maximum age listed. This encompasses the data that will be obtained on the 11 and 12 year olds as well as from the providers (who were/are subjects) and the parents."

Inclusion Criteria:

  • 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. For immunocompetent children (the overwhelming majority), for children less than 15 years of age, the newly revised ACIP recommendations call for two doses at zero- and six-months with the minimum interval being five months between the first and second dose. Some eligible patients may have received two doses too close together for this because of the previous three-dose recommendation was in effect until December 16, 2016, making the ACIP recommendations official. In these cases where the second dose is less than five months after the first, the individual should receive a third dose of HPV vaccine 12 weeks after the second dose and at least 24 weeks after the first dose. Thus, patients who are eligible and due comprise of three groups: those having received no valid HPV vaccine; those having received one valid HPV dose AND it has now been five calendar-months or more; and those having received two valid doses but Dose 2 was given less than five months after the first. Valid doses include doses given at nine years or older (the minimum age per ACIP) and meet the minimum intervals.

Exclusion Criteria:

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Jacobson, M.D.

Open for enrollment

Contact information:

Robert Jacobson M.D.

(507) 284-5243

jacobson.robert@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20506993

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