The PrEP IMPACT trial is a clinical trial and will operate differently to the ways you usually get sexual health services. You'll need to meet eligibility criteria to go on the trial, and you'll need to read and sign paperwork before you start. You'll also be asked to visit your trial clinic every 3 months for HIV and STI tests.
The PrEP IMPACT trial starts in September 2017 – and there are 5 important sets of things you need to know if you’re thinking about joining the trial!
Know if you’re eligible to go on the trial.
To take part you need to meet the eligibility criteria below, be 16 or older, and to have an England postal address.
There are THREE groups of people who are eligible:
Men (including trans men) who have sex with men, and trans women who have sex with men who:
are HIV negative and have had an HIV negative test in the previous 12 months
and have had sex without condoms in the previous three months
and who consider they will have sex without condoms in the next three months
The HIV negative partner of someone with diagnosed HIV when the HIV positive partner is not known to be virally suppressed, and when sex without condoms is anticipated.
HIV negative people who do not fit into either group above but whose situation is clinically assessed and considered to be at a similar high risk of HIV acquisition.
Who is not eligible?
You can’t go on the trial if you’re taking any other medication that might not interact well with PrEP. For example, some drugs used to treat Hepatitis C cannot be used with PrEP. The trial clinic will be able to answer further questions on drug interactions.
Not eligible but still want PrEP?
Some current PrEP users may not be allocated to the trial if they do not meet the criteria above. If you’re not eligible to go on the study and want to use PrEP, it’s possible to buy PrEP online safely and legally for around £35 a month. Find out more from HERE.
Being eligible doesn’t guarantee a trial place
The trial will enroll on a staggered basis. That is – not all clinics will open enrolment at the same time. Each participating clinic will be allocated a set number of places for the trial – and there will be more people eligible than there are currently places on the trial. It is not yet clear what will happen when all places are full. It is important to know that being eligible does not guarantee a trial place.
Know what kind of dosing regime to follow.
Taking PrEP every day
If your HIV risk is from vaginal/front-hole sex, then there is ONE option of how to use PrEP on the study. This option involves taking one pill of PrEP every day. This will be the most suitable option for women and transgender women having vaginal sex. It will also be protective for anal sex for women and transgender women.
Taking PrEP every day vs. on-demand dosing
If your HIV risk is from anal sex, then there are TWO options of how to use PrEP on the study.
ONE: If you know ahead of time when you are going to have sex then you can consider on-demand dosing. That is: taking PrEP before and after each episode of sex.
TWO: If you aren’t sure in advance when you’re going to have sex (or if you often have unplanned sex) then taking one pill of PrEP every day provides the most protection.
On-demand dosing is not suitable for transgender men who are having vaginal/front-hole sex. Daily dosing is the recommended option.
Men only having insertive sex
On-demand dosing might be suitable for men who are only having insertive anal (‘tops’) or vaginal sex. Most of the research has looked into daily dosing and there is currently not enough research to know for sure if on-demand dosing works as well in these circumstances.
Which option might be for you?
It’s useful to have considered before starting on the trial which option might be best for you. Staff at your trial clinic will be able to help you make a decision. You don’t have to stick with the option that you start with at your first visit – if your circumstances change you can change the way you take PrEP. More information about these two options is available in the videos below.
Know that this is a trial – and what that entails.
What’s the trial trying to find out?
The trial is trying to answer questions about how many people who attend sexual health clinics might need PrEP, and for how long. The trial is NOT trying to establish if PrEP works or not – research already shows that PrEP works VERY well. Everyone who takes part in the trial will be given real PrEP that works. No one is getting a placebo drug (dummy pills) in this trial.
How long will I get PrEP for?
Being on the trial gives you FREE PrEP for as long as the trial lasts (until at least September 2020). There is no guarantee that PrEP will be provided when the trial stops.
What happens if I stop using PrEP?
Once you’ve started on the trial you can decide to stop taking PrEP if you no longer feel it’s right for you. If you do this, you’ll be able to go back on to the trial and get PrEP at a later date if you decide to (for as long as the trial lasts). That is: your trial place won’t be taken by someone else if you decide to have a break from PrEP.
Should I enroll at my local clinic?
Almost every sexual health clinic is taking part in the trial - so there will be trial places wherever you live in England. Different clinics will start enrolling at different times - and each clinic is working as fast as possible to get ready to start. Enrolling at the local clinic that you usually attend means you won't have to travel to attend trial clinic visits. Keep up-to-date about when your local clinic will start recruiting to the trial by visiting www.prepimpacttrial.org.uk
Can I swap clinics?
If you need to transfer to another clinic during the trial (for example, if you've moved to a new town or city) then you'll need to speak to your original trial clinic. They'll arrange for the necessary information and papers to be given to the new trial clinic.
Can I enroll at more than one clinic?
It's important that you only enrol at one clinic. If you enrol at more than one, you'll be taking a place on the trial that could've gone to someone else.
Know what needs to happen before you start on the trial.
Understanding the patient information sheet
Before you start on the trial you’ll be given a document called a Patient Information Sheet. Take time to read the Information Sheet at the clinic and ask the clinic staff if there’s anything you do not understand. The Patient Information Sheet can be viewed on the trial’s website.
Signing the Consent Form
Once you’ve read the Information Sheet and had the chance to ask any questions, you’ll be asked to sign a Consent Form. Consent Forms are normal for trials – and they are a way of making sure you understand what the trial is about. Staff in the clinic should make sure you fully understand what the trial involves before you sign the form. Remember that you can withdraw from the trial at anytime.
What other paper work will I need to complete?
Apart from this Consent Form you will not have to complete any other paperwork for the trial (other than paperwork you would normally be expected to complete for a clinic visit).
What tests will I have on my first clinic visit?
On your first trial clinic visit you’ll need to have a blood test for HIV plus a full STI screen. The clinic will also check that you’re protected against Hepatitis B, and might also be tested for Hepatitis C. You’ll also be given a blood test and a urine test to ensure your kidneys are working well. Once those tests have been taken, you’ll be given up to 3 months supply of PrEP.
How often will I have to visit the trial clinic?
For as long as you’re taking PrEP on the trial, you’ll need to visit your trial clinic every 3 months. At these visits you’ll get an HIV test, and other STI tests if they are needed. You’ll get another 3 months supply of PrEP, if you’re still eligible for it, at each visit. After 12 months of taking PrEP, you’ll get a blood test to check that your kidneys are still healthy. This test will get repeated every year that you’re using PrEP.
Can I get STI tests outside of trial clinic visits?
If you think you’ve been exposed to STIs, or have symptoms, then it’s important to be tested and treated – don’t wait until your next trial clinic visit! Contact your clinic for an appointment.
What about possible side effects?
When you enroll on the trial you’ll be given information about possible side effects of using PrEP. A small number of people experience minor side effects when they start PrEP – and for most people these go away after a week or so. Very few people have to stop taking PrEP because of side effects – but it you experience unpleasant side effects then let you trial clinic know.
What should I do next?
If you think PrEP is right for you, you’re eligible, and ready to start, then visit the trial website to find out if your local clinic has started recruitment. The information provided on PrEPster’s website should not replace the pre-recruitment information provided by your local clinic. Remember – you have the right to ask any question to the clinic team before you join the trial.