Quest HPV Study
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Study Details

WHY:
The goal of the QUEST HPV study is to look at the HPV vaccine’s protection against the HPV infection, how long this protection lasts, and if there are any differences between the girls that got 2 or 3 doses of the HPV vaccine.
WHO:
The QUEST study will seek to recruit 8,666 females from across Canada who will range in age from about 14 to 18. Girls will be asked to take part in this study if they have received 2 or 3 doses of the HPV vaccine as recommended by their provincial public health program
WHERE:
There are five provinces taking part: British Columbia, Alberta, Quebec, Nova Scotia, and PEI.
LENGTH:
The length of time on study will vary from girl to girl and will be based on her age at enrolment to the study and on her age when she got the first dose (shot) of HPV vaccine.  For example if a girl starts the study 5 years after her 1st shot she will be on study for 5 years but if a girl starts the study 3 years after her 1st shot she will be on study for 8 years.  The girls will be on the study for up to 10 years after the first HPV vaccine shot; most will be on study for less than 10 years.
STUDY ACTIVITIES:
(Details for these study activities are listed below)
1) Online questionnaire (survey) sent once a year
2) At-home/self administered vaginal swab sent twice a year
3) Optional blood test
FUNDING:
Funding for the study was provided by the Michael Smith Foundation for Health Research (research support agency) after the researcher’s proposal was reviewed and accepted.

STUDY ACTIVITIES:

 

     1) Online questionnaire (survey) 
    • This survey will ask for information about demographics and sexual health (ie. about your period or having sex)
    • Reason for survey: To look at risk factors for getting the HPV disease

 

     2) An at-home/self administered vaginal swab 
    • During the year in which a participant turns 15 (or if it has already been 5 years since the first HPV shot), she will be sent an at-home kit twice a year to collect a vaginal swab. She will do the swab herself. Once collected, the swab is mailed back to us. (watch this 2 minute instructional video about the swab kit)
    • Girls find this swab test very easy, just like putting a small Q-tip TM into their vagina and pulling it back out (similar to the way a tampon is inserted)
    • Reason for vaginal swab: The swab is a research test to look for any kind of HPV infection so we can find out if there is any HPV disease at the time of the swab. The tests on the swab will not be done right after it gets sent to us, but will be tested in big batches. You should know that there is no HPV treatment and about 10% of the population in Canada has HPV disease at any given time, most people don’t know they have it and in most cases the infection will clear on its own.   By the time we do the test on the vaginal swab, the information will be old, and the girl may or may not have cleared the infection on her own if she was positive to HPV disease on the test. Because of this reason neither study participants nor their doctors will get the test results. That is why it is important to have regular PAP tests when you  become sexually active since it will detect any abnormal cells immediately

 

     3) Optional Blood test (participants receive a $10 gift card for each blood test)
    • Some girls will be asked to do an optional blood test. Girls will be asked to do a blood test if she is living close to a regular lab (i.e. LifeLabs®) and willing to have her blood collected twice during the study
    • The first blood test would be 5 years after the first dose of HPV vaccine and the second would be 5 years later when it has been 10 years since the first HPV vaccine.
    • Participants will receive a lab requisition form and a blood tube label in the mail to take to a regular lab.
    • Taking part in the blood collection portion of the study is entirely up to the study participant. She may decide to stop doing the blood samples at any point without telling us why. If a first blood sample is collected but a girl later changes her mind and doesn’t want to complete the last sample, the first blood sample will be discarded.
    • Reason for blood test: To look at the antibodies (proteins) and other signs of protection in the blood that will tell us if there is still protection from HPV disease. It is important that we find out how long protection lasts by testing the blood several years after the vaccines were given.

 


PRIVACY

As with all parts of the study, personal information and any test result is kept private and this means that the study staff will keep everything a girl tells us very private. Each girl will get assigned a personal study number (code) once enrolled on the QUEST study.  This code or personal identifier number (PID#) is the one that will be used on all lab forms, blood samples, and vaginal swabs, so no personal information will go to any of the labs.