What is this study for?
This study is to find out about different ways to offer a self-test for cervical screening to women, so that more women get checked to prevent cervical cancer. In the self-test, women use a swab to sample their vagina to find out if they have the human papillomavirus (HPV). HPV is a virus spread by skin-to-skin contact and some types are linked to cervical cancer. The new self-test is different from, but as good as, the usual smear test which a nurse or doctor does.
What am I being asked to do?
A nurse, doctor or your service provider will talk to you about the self-test and any advantages or disadvantages compared to the usual cervical screening test. Making a choice about having a cervical screening self-test is your decision. The self-test is being offered as part of a research study so you will need to provide your consent if you choose to do it. You can use the kit and instruction sheet to do the self-test. If you are offered the self-tests at your GP clinic or by your service provider, you can do the self-tests at their premises or take the kit home and return the sample to your GP clinic or service provider. If you are offered the self-tests through our Cervical Screening Support Team via a text message, you will be given an option of speaking to a member of the research team if you have any questions.
How will I find out the results of my self-test?
A study nurse will contact you with your results two or three weeks after your test. If your test results show you do not have HPV, you don’t have to do anything else. Your nurse or doctor will let you know when you are due for your next cervical screening test. You will have the option of answering some short questions about your experience being offered the self-test.
What if my test results show I have HPV?
A test result that shows you have HPV does NOT mean you have changes to cervical cells or cervical cancer. The study nurse will talk more about what the test results mean. Depending on the result, it might mean you need to have a follow up smear, or it might mean a visit to a specialist (a colposcopy at a hospital clinic-which is a simple procedure to look at your cervix). There will be no charge for any follow-up tests.
We strongly recommend that you complete the follow-up tests to look for any cell changes that might need treatment. We will talk with you about the follow-up tests and answer all your questions. We can talk with you and your whānau / family if you want us to. The study nurse can also arrange help so you can get to the clinic.
More about the HPV self-test
The new self-test is a very accurate test to check for HPV. You don’t need to know where your cervix is to do the test. The new self-test does not check for other sexually transmitted infections (STIs) such as Chlamydia or HIV. Some HPV tests are currently available with a cervical smear taken by a doctor or nurse. However, the self-test is currently not offered to all people. The self-test is only being offered as part of some studies for now.
Is doing the HPV test myself right for me?
Many people find doing the self-test easier than getting a smear with their nurse or doctor. If you have had a hysterectomy, or previously had an abnormal smear result, ask the study nurse whether the self-test is right for you. If you had the HPV vaccine, you can still take part in the study. If, at any time, you wish to opt out of self-testing and have a smear test, talk to the study nurse or your own doctor or nurse.
More about HPV
HPV is very common. Four out of five people will have HPV at some time in their lives. Some types of HPV stay in the body for a long time. For most people, having HPV does not cause any problems. Your body gets rid of the virus by itself. Having HPV doesn’t mean that your partner is being unfaithful to you. You could still have HPV even if you are in a long-term relationship with one partner, not currently having sex or have not had sex in a long time.
To find more information about how HPV is linked to cervical cancer visit www.hpv.org.nz
How is HPV Treated?
There are treatments for cell changes to your cervix caused by HPV. This is why it is important for you to have follow-up tests if your results show you have one of the types of HPV that can cause cervical cancer. Treatment happens at a hospital clinic and is successful at stopping serious cell changes from becoming cervical cancer.
National Cervical Screening Programme
You can find more information about cervical screening and follow up tests online at www.timetoscreen.nz
Everyone who participates in this study will be invited back for another cervical screening test when they are next due. If you have unusual bleeding, pelvic pain, or discharge, please talk with your doctor or nurse - don’t wait for your next screening test.
Who is doing the study?
The study is a joint project between Tāmaki Health, Total Healthcare PHO, Te Whatu Ora – Waitematā, Te Toka Tumai Auckland and Counties Manukau districts.
Withdrawing from this study?
Being part of this study is your choice. You can choose not to take part, or to withdraw from the study at any time. Your care won’t be affected in any way. If you withdraw from this study, we will keep the information we have collected up until the time of your withdrawal. We will not collect any new information after that.
It is not likely that you will get injured in this study. If you did, you would be eligible to apply for compensation from ACC just the same as if you were injured in an accident at work or at home. You would have to put in a claim to ACC, which might take some time to be assessed. If your claim was accepted, you will receive funding to help you recover. If you have private health or life insurance, you may wish to check with your insurer that taking part in the study won’t affect your cover.
Privacy and confidentiality
Your test results will be shared with your usual nurse or doctor to make sure you get the correct follow-up. Other people who will have access to information that identifies you (your name, date of birth or address) are study team staff (to track participants and complete study assessments) and laboratory staff (to process and report your screening tests).
You have the right to access and correct your information. In the same way as with a smear, your name and test results will also be held on the National Cervical Screening Programme Register and one of the laboratory registers (TestSafe / Éclair).
Your self-test or smear sample will be stored by the laboratory for the usual amount of time (for quality checking). To keep your information confidential during the study, you will be identified by a code so that your name will not be used on the study documents.
People and providers working with or for the study sponsor (about 20 people) may have access to coded information for the purposes of this study. Although all efforts will be made to protect your privacy, absolute confidentiality of your information cannot be guaranteed, even with coded information. The risk of people accessing and misusing your information is very small.
Thank you for thinking about being part of the study. If you have any further questions, or complaints about the study, you can contact:
Dr Karen Bartholomew, Lead Researcher for this study.
Phone: 09 486 8920. Ext: 5434. Mobile: 021 211 5629.
MĀORI CULTURAL SUPPORT CONTACT
Auckland and Waitematā:
He Kāmaka Waiora
Phone (09) 486 8324. Ext. 42324.
Te Kaahui Ora Maaori Health