HPVNCT03083249
Gardasil Knowledge
An observational study of HPV, run by Sarah Hostetter, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women only
- Conditions the study is for
- HPV
- What is being tested?
- Gardasil
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 26 years
- Women only
- No healthy volunteers
- Adult
Study population: Females age 18-26 of all ethnic background
Who may be able to join
- All patients 18-26 will be offered participation
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gardasil Anonymous Survey
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.
Read the 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.
- Conditions
- HPV
- Being tested
- Gardasil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GardasilOther
None-data gathering only
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge about HPV risk factors
The survey asks about Gardasil vaccine knowledge
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Feb 2017
- Primary completion1 May 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Hostetter, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Hostetter, MD, St. Louis University
- Investigators
- Sarah Hostetter, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083249
- Sponsor's protocol ID
- 27816
- Status last verified
- Jun 2018
- First submitted
- 3 Mar 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gardasil Anonymous Survey
- ClinicalTrials.gov ID
- NCT03083249
- Acronym / sponsor ID
- 27816
- Conditions
- HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sarah Hostetter, MDUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females age 18-26 of all ethnic background
Key inclusion criteria (1 listed)
- All patients 18-26 will be offered participation
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
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 |
|---|---|---|
| GardasilNone-data gathering only | Other | – |
Primary outcome
knowledge about HPV risk factors
Time frame: 1 year
The survey asks about Gardasil vaccine knowledge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
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CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
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HPV Vaccination
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.
Sarah Hostetter, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV, run by Sarah Hostetter, MD 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 1 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 6 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
knowledge about HPV risk factors (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2018.