Gardasil Knowledge

• Sponsor: Sarah Hostetter, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03083249
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	Phase
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.

Study Design

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

Outcome Measures

Primary Outcome Measures

1. knowledge about HPV risk factors [1 year]

   The survey asks about Gardasil vaccine knowledge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 26 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients 18-26 will be offered participation

Exclusion Criteria:

• Not meeting the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Mary's Health Center	Saint Louis	Missouri	United States	63117

Sponsors and Collaborators

• Sarah Hostetter, MD

Investigators

• Principal Investigator: Sarah Hostetter, MD, St. Louis University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Hostetter, MD, Principal Investigator, St. Louis University
• ClinicalTrials.gov Identifier: NCT03083249
• Other Study ID Numbers: 27816
• First Posted: Mar 17, 2017
• Last Update Posted: Jun 6, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 6, 2018