The PrEP Impact Trial during the COVID-19 (coronavirus) outbreak

updated 26/03/2020

Dear Participants,

 

The current COVID-19 (coronavirus) pandemic is having an unprecedented impact on daily living, individual and public health and NHS capacity to cope with this emergency. Everyone is being called upon to play their part in order to avert as many deaths as possible. This includes following government advice and undertaking social distancing. This means you should stay at home, undertaking only essential travel and keeping at least 2 metres from everybody who is not part of your household.

Sex and intimate contact is a risk for COVID-19 transmission. While severe illness and deaths are occurring mostly in the elderly and vulnerable, younger people are also being affected.

Given the crisis, clinical capacity for research-based activity is already being severely limited across the NHS. The PrEP Impact trial will remain open but in almost all services recruitment is likely to be paused. Follow up visits will be decided based on local circumstances and we have made some changes to the trial to try and make this easier for services and for participants to continue to access PrEP where possible and if still required.

If you require current information about coronavirus please go to https://www.gov.uk/coronavirus

Below is some additional information regarding the PrEP Impact Trial and taking the study medication.

At this time we would ask that you do not try to attend for your PrEP Impact visit earlier than expected.

Our participating clinics will need to make numerous accommodations for the COVID-19 pandemic; this will take time and we do not want to burden them further.

Section 1: Participation in the PrEP Impact Trial

It is still safe for you to take PrEP as instructed and continue on the trial. There have been some changes to the trial protocol which are listed below.

These changes have been made to ensure participant safety both as trial participants and to reduce travel related risks surrounding COVID-19, including making sure the trial clinics can continue to deliver the trial with reduced capacity.

We ask that all our participants keep informed of the ongoing COVID-19 risk. Please refer to the PHE guidance on how to protect yourself and others:

https://www.gov.uk/coronavirus

1. Is the PrEP Impact Trial still running?

Yes. However the Impact trial team and Trial Management Group have agreed to several changes in how the study is run.

All changes made to the trial have been submitted to the Health Research Authority (HRA), using their guidance for conducting research under COVID-19 planning.

2. Can I still attend my PrEP Impact appointment for an STI screen and prescription?

The schedule of your visits may change, and there might be changes to how a visit is conducted. In some cases services may have to stop the trial and follow up visits, if the situation continues to worsen as expected. If this affects you and you wish to continue on PrEP, the i-base leaflet ‘UK guide to PrEP’ includes information on alternative ways to access PrEP in the UK until your local service is able to restart the trial. (http://i-base.info/guides/prep/introduction-and-access)

Each clinic will be undertaking their own individual risk assessments on how best to proceed, they may adopt only some or all of the items listed below. Your clinic may contact you to inform you of any alterations made to the trial pathway, or may instigate some of the changes at your next trial visit.

Changes made to the PrEP Impact Trial protocol

  • Clinics can now issue 6-month prescriptions to participants.

If you receive a 6-month prescription you should still have an HIV test and, if possible an STI screen, 3 months after your PrEP was dispensed. This can be done through an online testing service or other local arrangements that will be made by your clinic.

  • In some cases telephone consultations may be conducted to reduce footfall in clinic.

 

  • Certain assessments (such as creatinine (kidney) testing) may be missed or deferred where appropriate and safe to do so.

Any missed follow-up assessments will be performed at the earliest time possible once the risk of COVID-19 is acceptable and clinical capacity allows.

  • Individual clinics may make additional adjustments in accordance with their Trust policies. They will keep the Impact trial team informed of any such changes, so safety of trial delivery will be maintained and monitored.

 

3. How will I receive or pick-up my prescription?

It will be up to your individual clinic how prescriptions and pick-ups are managed. If the Principal Investigator of a clinic determines it is in your best interests not to visit the hospital/site they will give you further guidance on how to access your prescription and study drug.

 

4. If I stop/pause PrEP or am unable to attend my follow-up visit will I have to stop the trial?

No.

Any trial participant may stop taking PrEP without withdrawing from the trial, and then start again at a later date provided they again meet the eligibility criteria.

For guidance on stopping and restarting PrEP in the current circumstance please see Section 2 below.

5. What if I contract COVID-19?

 

If you suspect or know you have contracted COVID-19 you should not attend clinic. Follow the NHS advice on steps you need to take:

 

https://www.nhs.uk/conditions/coronavirus-covid-19/

 

You should inform your trial clinic if you have been diagnosed with COVID-19 at the earliest opportunity; this may need to be at your next trial visit. If you are still taking PrEP and have recently had sex please see the advice in Section 2 about how to stop safely.

 

6. I am not currently a participant on the PrEP Impact Trial, can I still join?

We anticipate many of our sites will reduce or pause to recruitment for the moment as they do not have the capacity to safely take on further participants at this time. You can find your local clinic through our website; many are providing local information about their recruitment status.

https://www.prepimpacttrial.org.uk/join-the-trial

If you are currently unable to join the trial, the i-base leaflet ‘UK guide to PrEP’ includes information on how to access PrEP in the UK:  

 

http://i-base.info/guides/prep/introduction-and-access

 

Section 2: Taking PrEP

This information was compiled by HIV Scotland, in collaboration with BASHH, BHIVA and i-base.

1.  Can I stop taking my daily PrEP?

If you are planning to stop having sex, you may wish to stop daily dosing PrEP.

PrEP is very flexible if your circumstances change.

Before you stop, cis men* should carry on taking PrEP for another two sex-free days.

Everyone else should carry on taking PrEP for seven sex-free days. This includes when PrEP is being taken for vaginal/frontal protection.

*Cis man refers to anyone who was born male and who still identifies as a man.

2. Does PrEP prevent or treat COVID-19?

No. The drugs used for PrEP do not prevent COVID-19.

They do not work to treat COVID-19.

Please do not increase your regular PrEP to prevent or treat COVID-19. Do not share PrEP with anyone to prevent or treat COVID-19.

3. Can I change from daily dosing to event based PrEP?

Only cis men* who have sex with other men can safely change from daily dosing to Event Based PrEP.  Anyone  who also has Hepatitis B infection should take daily PrEP.

Everyone else, including for vaginal/frontal protection, can only use daily dosing. Event Based PrEP is not suitable. For more information on Event Based PrEP please see the PrEPster website: www.prepster.info/ebp

If you can use event-based PrEP, this involves:

  1. Taking a double dose 2 to 24 hours before sex.

  2. Taking a single pill every 24 hours, until you’ve had 2 sex free days.

For example, if you have sex once, this will involve a double dose before sex. Then a second pill after 24 and 48 hours. Total = 4 pills.

*Cis man refers to anyone who was born male and who still identifies as a man.

4. How can I safely restart PrEP?

If you have not had sex since stopping, then it’s okay to start PrEP as usual.

If you’re a cis man, you should take a double dose 2 to 24 hours before sex if you want to have sex straight away. You can then continue with either daily dosing or event-based dosing (see above).

Everyone else should take daily doses for seven days before sex. This includes for vaginal/frontal protection.

5. What if I’ve stopped PrEP and have the chance to have sex?

 

If you have the chance to have sex, event based PrEP will be okay – but only if you are able to use this option.

Not everyone can use EBP safely so check here for more information:  https://www.prepster.info/ebp

If you have sex and you didn’t use PrEP, you can still use PEP. This involves using a daily combination of three HIV drugs for one month. You can find out more about PEP here: https://www.hiv.scot/Pages/FAQs/Category/pep

© 2017 PrEP Impact Trial