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Gardasil Knowledge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03083249
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : June 6, 2018
Information provided by (Responsible Party):
Sarah Hostetter, MD, St. Louis University

Brief Summary:
Human papillomavirus (HPV) is the most common viral genital tract infection. The majority of women and men who are sexually active will be exposed to a strain or strains of the virus. While there are hundreds of viral strains, high risk strains are associated cervical and oral cancers. According to the Centers for Disease Control (CDC), between 2008 and 2012 there were 38,793 deaths attributed to HPV related cancers. Vaccinations were created in an attempt to prevent infection from the most common high risks strains of HPV. Gardasil/HPV-9 was created to help prevent HPV related cancers and warts. The HPV-9 vaccine includes protection from 7 strains of HPV associated with 74% of HPV related cancers. While Gardasil was approved and released in 2006, many men and women have not been vaccinated. A national immunization survey in 2011 of teens 13-17 years old noted that only 60% of girls and 40% of boys have received at least one vaccination in the series. While complete vaccination series is recommended, a recent study found that a single dose of Gardasil when compared to placebo created a higher level of serum antibodies in uninfected females.

Condition or disease Intervention/treatment
HPV Other: Gardasil

Detailed Description:
All patients seen at a single clinic will be offered participation in the anonymous survey. The survey will ask a series of questions regarding basic demographics, sexual history, smoking status, and Gardasil vaccine knowledge. The survey will serve as evidence of the vaccine utility by highlighting patient risk factors for HPV and patient knowledge about the vaccine series.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gardasil Anonymous Survey
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : June 1, 2018

Intervention Details:
  • Other: Gardasil
    None-data gathering only

Primary Outcome Measures :
  1. knowledge about HPV risk factors [ Time Frame: 1 year ]
    The survey asks about Gardasil vaccine knowledge

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females age 18-26 of all ethnic background

Inclusion Criteria:

  • All patients 18-26 will be offered participation

Exclusion Criteria:

  • Not meeting the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03083249

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United States, Missouri
St. Mary's Health Center
Saint Louis, Missouri, United States, 63117
Sponsors and Collaborators
Sarah Hostetter, MD
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Principal Investigator: Sarah Hostetter, MD St. Louis University

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Responsible Party: Sarah Hostetter, MD, Principal Investigator, St. Louis University Identifier: NCT03083249    
Other Study ID Numbers: 27816
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No