Cervical Screening Self-Test Study

Self-testing is when women collect their own sample for cervical screening using a swab in their vagina. This can be done in private or with the support of a nurse or doctor – it’s your choice.

The sample is then tested for the presence of the human papillomavirus (HPV), the virus that may cause cervical cancer.

Self-testing is for people who are eligible for cervical screening. In this study it includes people who are:

• 30-69 years
• Due for cervical screening
• Never had cervical screening.
• Attend clinics that are participating in the study.

Note that for some people, having a smear test might be a better choice.

We recommend that you see your Nurse or Doctor for a smear or contact the Study Nurse if you:

• Have bleeding discharge or pain that worries you
• Have had a high-grade smear in the past and have yearly smears
• Have had a hysterectomy
• Have had cervical cancer

If you have any questions, please feel free to get in touch with the Cervical Screening Self-Test Support Team on 0800 747 354.

How will self-testing kits be offered to you?

The study is for women aged 30-69 years who are due, overdue for cervical screening or never been screened and is only being offered in some clinics and other settings in Auckland. The study has three main pathways for offering the self-test kit:

1. Opportunistic offer in clinics. Eligible women will be offered the self-test when they visit a participating GP clinic for any reason. Women will have the option of collecting the sample in the clinic or taking a test kit home
2. Mail-out offer: Eligible women will be contacted via text message by the Study Team. Consents can be completed electronically or after discussion with a member of the study team. Kits will be mailed to the woman’s home address and can be returned via free courier or dropped at the GP clinic.
3. Other health settings: Some eligible women may be offered a self-test kit through another health service such as an outpatient clinic or pharmacy.

All screening tests and any follow-up is free during this study.

Because the self-test is being offered as part of a research study, if you choose to have a self-test you will need to provide your consent. You will have the option of answering some short questions about your experience after being offered the self-test.

Women who decline to take part in this study or do not return a self-test will remain eligible for cervical screening under the National Cervical Screening Programme.

The self-test kits mailed out contain everything needed to collect and return a self-collected sample: a swabwritten and pictorial instructions, study brochure, laboratory request form and a prepaid pre-addressed envelope for returning samples to the laboratory.

Taking your self-test is simple; you can do it! Research shows that 99% of people do it correctly.

You don’t need to find your cervix to do the test.

Step 1: Get Ready

• Ensure your hands are clean and dry before you take your test.
• Before you begin, take a moment to relax; you may wish to take a few deep breaths beforehand to relax your body and mind.

Step 2: Take the test

• Open the sealed pack and take out the swab, holding it close to the red mark on the stick. This is your guide on how far to insert the swab.
• When you are ready, gently insert the swab into your vagina.
• Slowly rotate the swab in a circular motion for 20 seconds. This shouldn’t be painful or uncomfortable.

Step 3: Finishing the test

• Gently remove the swab and place it back into the tube that it came in.
• Tightly screw the cap onto the tube.
• Place the swab tube back into the plastic testing bag.
• Wash your hands after taking the test.

What if I make a mistake?

It is okay to continue with the test if you:

• Have touched the swab with your fingers
• Have dropped it onto a dry surface
• Have inserted the swab into your vagina but are unsure if the distance is correct.

If you are still worried you have made a mistake, or have any questions, please get in touch with our Cervical Screening Self-Test Support Team on 0800 747 354.

Are there any special handling requirements?

Your self-test can be stored at room temperature. Please arrange for your self-test to be returned as soon as possible.

What happens next?

We will contact you via text message with your result 2 to 3 weeks after you return your self-test.

Kōrero mai

Your feedback is important and will help decide how self-testing is done in the future.

After we contact you with your result, we will send a link to a survey – we want to hear what you think, so please let us know!

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.

ACC statement

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.

Further information

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.

Email: Karen.Bartholomew@waitematadhb.govt.nz

MĀORI CULTURAL SUPPORT CONTACT

Auckland and Waitematā:

He Kāmaka Waiora

Phone (09) 486 8324. Ext. 42324.

Counties Manukau:

Te Kaahui Ora Maaori Health

tekaahuiora@middlemore.co.nz

Is a cervical screening self-test right for me?

It’s your choice. From July 2023 women can choose how they do a cervical screening test as part of the National Cervical Screening Programme (NCSP). Many wāhine will want to self-test when the option is available. Some may still prefer to have a cervical smear test in the usual way. For a small number of people, a self-test might not be recommended due to previous cervical screening results.

Are you researching if self-testing is as effective as the regular smear test?

No, this is not the research topic. Self-testing is as accurate as a test taken by a nurse or doctor to check for HPV; and is a more effective test than the current smear test. Self-testing for HPV is part of cervical screening in other countries like Australia, Denmark and the Netherlands and will become part of the National Cervical Screening Programme in 2023. This study is about how best to offer and deliver self-testing to wāhine, whānau and people in Aotearoa.

I have had the HPV vaccine; do I need cervical screening?

Yes, if you have been immunised you still need regular cervical screening tests. While the vaccine protects against the 9 most common types of HPV it doesn’t protect against them all, so it’s important to have cervical screening even if you have had the HPV vaccine.

I’m not sure if I am due for screening, how do I find out?

This study is for women due or overdue for their cervical screening. If you’re not sure if you are due, you can talk to your nurse or doctor, or you can ring our Cervical Screening Self-Test Support Team on 0800 747 354.

If I’m pregnant, can I still take part in the study?

Yes, the self-test is safe for hapū (pregnant) māmā. There are no safety concerns with people who are pregnant self-testing with a vaginal swab.

I have had a hysterectomy, am I still eligible for the study?

Some people who have had a hysterectomy are still recommended to have regular screening and may be eligible for a self-test. Some will no longer need screening. Talk to your nurse or doctor about if the study is right for you, or you can ring our Cervical Screening Self-Test Support Team on 0800 747 354.

I have had recent treatment after a cervical smear test.

Talk to your nurse or doctor about if the study is right for you, or you can ring our Cervical Screening Self-Test Support Team on 0800 747 354.

I’m doing the self-test; can my whānau member to also take part in the study?

We can check. This study is for people who are eligible and enrolled in participating clinics. You can talk with our Cervical Screening Self-Test Support Team on 0800 747 354.

I have never had sex, am I eligible for the study?

No, people who have never had sex are not eligible for cervical screening. Talk to your nurse or doctor if you are worried about HPV and are not eligible for cervical screening.

How do I know if I’ve done it correctly.

Research shows that 99% of people take a self-test correctly. Along with each testing kit is an easy-to-follow instruction sheet to help you take the sample.

You do not need to know where your cervix is to do this test. HPV lives in the genital area instead of just the cervix, so taking your sample from the vagina will pick up whether HPV is present.

Can I take the sample when I have my period?

You can do the self-test when having your period. However, only do this if you are comfortable - otherwise wait until your period has finished.

Can my self-test be checked for STI’s?

The self-test does not check for sexually transmitted infections (STI’s) such as chlamydia or HIV.

How is my data going to be used in the study?

The cervical screening self-test study will collect anonymous data on all women who are eligible for the study, regardless of whether they return a self-sample. This data will allow us to assess our study endpoints which will tell us about how effective self-testing is and what groups of women self-testing appeals to. The study will only collect information relevant to cervical screening. All information will be kept confidential and securely

You will receive your results from the cervical screening study team. They will usually contact you by text message first to arrange a time for you to talk with a study nurse about your result, what happens next, and answer any questions.

A small number of women will test positive for HPV on their self-test. If you test positive for HPV, it does not mean you have cervical cell changes or cervical cancer, but it does mean you need to have follow-up care. The study team is available to support you through the follow-up process and can arrange for a Kaiāwhina (support person) to help you get to appointments and support you and your whānau through the process.

A self-test for HPV is used for cervical screening to predict your risk of cervical cell changes that may cause cervical cancer. There are four possible results from the cervical screening self-test process:

1) Negative Result: HPV not detected:

No HPV was found on your sample. There is a very low chance of developing cervical cell changes that would need treatment in the next five years. For that reason, it is safe to have your next cervical screening test in five years’ time

Remember, if you experience any symptoms before your next test, such as abnormal bleeding, see your doctor or nurse without delay, even if your last cervical screening test was normal.

2) Positive Result: HPV detected (16 or 18 type)

Your test results shows that you have HPV types 16 and/or 18, a follow up test with a specialist at a colposcopy clinic is recommended to assess for changes to cervical cells that may cause cervical cancer. Further follow up will be recommended.

3) Positive Result: HPV detected (Other Non 16/18 type)

Your results show that you have one of the other (non 16/18) HPV types.  A follow up smear test is recommended to look for cervical cell changes that may cause cervical cancer. Further follow up will be recommended if the follow up smear test shows cell changes.

4) Invalid Result:

An invalid test result occurs when the swab didn’t touch the side of the vagina or when there is a lot of discharge or blood present. If your result is invalid the study nurse will contact you to offer support with a follow up test.

Some people do feel worried about their result, you are welcome to contact our study nurse or Kaiāwhina with any questions or concerns on 0800 747 354

If you want to know more about HPV visit https://www.hpv.org.nz/ 

About your self-test results

Is it safe to wait for 5 years for my next cervical screening if I test negative?

Yes – A negative HPV test means you don’t have an HPV type that is linked to cervical cancer. It is safe to wait five years for your next screening test.

Testing for HPV is a more sensitive first test than the usual smear test. If you don’t have HPV your risk of developing cell changes that may cause cancer within five years is very low. There are now hundreds of international studies that prove this.

The usual smear tests detect cell changes that occur because of the presence of HPV and needed to be done every 3 years.  This is part of why Aotearoa’s cervical screening programme is changing to an HPV primary test next year. If you don’t have HPV, it is very unlikely that you will have cervical cell changes that can cause cancer.

Even if you were to develop an HPV infection the day after your test, you would still be at very low risk, as it can take 10 to 15 years for cervical cancer to develop following infection with HPV.

I have HPV - what about my partner?

You can have HPV for a long time without ever knowing it. HPV can stay in the body for 10-20 years. Finding out you have HPV doesn't mean you or your partner have been unfaithful.

It's your decision whether or not to tell your partner you have HPV.

If you do decide to tell your partner you have HPV, it might help to include these points:

• HPV is very common in everybody who has ever had sex - four out of five people will have HPV at some point in their lives, and most won't even know it
• you can have HPV for a long time without ever knowing it, finding out you have HPV doesn't mean you or your partner have been unfaithful
• it is difficult to know who gave you HPV, both because the virus is so common and because it can remain dormant in cells for more than 10 years before becoming active
• there is no reason to stop having sex because you have HPV.

I’m hāpu (pregnant) can I pass HPV on to my baby?

Studies show that passing on HPV during childbirth is very rare; it is also completely safe to breastfeed if you have HPV.  If you are hāpu and have HPV we recommend that you let your Midwife or Lead Maternity Carer (LMC) know. 

Does HPV have symptoms?

No – HPV does not have symptoms. Some people ask if vaginal discharge and feeling itchy or uncomfortable are caused by HPV. These symptoms are not caused by HPV. If you have discharge or symptoms that worry you see your doctor or nurse for a sexual health check.

Is there treatment for HPV?

There is no treatment for HPV, and in most cases, HPV is cleared by the body naturally. Some other types of HPV can cause genital warts – The self-test for cervical screening does not look for genital warts. If you have think you have genital warts, speak with your doctor or nurse to arrange treatment.

Does HPV affect men?

HPV can affect men as well. HPV can cause anal, penile, head and neck cancers. There is currently no approved screening test for HPV in men. Anyone concerned about these cancers should speak with their doctor or nurse.

HPV can also affect transmen. Cervical screening is the best way to detect HPV in transmen and can be discussed with the Study Nurse.

What about cervical cancers that aren’t caused by HPV?

Cervical cancers that aren’t caused by HPV are very rare, accounting for less than 1% of all cervical cancers. There is no effective screening test for these cervical cancers. Neither the usual smear test nor the HPV test is able to detect these rare cervical cancers 

I have another question?

You are welcome to contact our Cervical Screening Self-Test Support Team on 0800 747 354 with any questions you have.

For any questions, please contact:

Cervical Screening Self-Test Support Team on 0800 747 354

Email: hpvstudy@waitematadhb.govt.nz

Dr Karen Bartholomew, Lead Researcher.

Phone: 09 486 8920. Ext: 5434. Mobile: 021 211 5629.

Email: Karen.Bartholomew@waitematadhb.govt.nz