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 under 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. 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





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