COVID-19 & FAQs | PrEP Impact

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.

Pre-exposure prophylaxis, or PrEP, is medication taken by an HIV negative person, who is at substantial risk of HIV infection so as to reduce their risk of acquiring HIV. This involves taking PrEP as instructed, before any exposures that might put them at high risk of getting HIV. The single-tablet PrEP drug contains two medicines (tenofovir and emtricitabine) which are also used to treat HIV infection.

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, ideally 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.

The PrEP Impact Trial aims to answer key questions about the use of PrEP in England. The trial was announced by NHS England and Public Health England in a joint statement on 4th December 2016. The trial is planned to last three years. It initially aimed to recruit 10,000 participants at high risk of acquiring HIV; this has now been increased to 26,000.

Whilst the efficacy of PrEP has been clearly established in multiple trials across the world, including the PROUD trial that was conducted in England, the relatively small number of people enrolled in that trial meant that some key questions about large-scale use of PrEP in England remained. The PrEP Impact Trial aims to address the outstanding questions about eligibility, uptake and length of use.

The trial is a health technology assessment of PrEP and its implementation, that is, it aims to answer the key questions under real world conditions and at sufficient scale. In addition, the new trial will assess the impact of PrEP on the overall number of new HIV diagnoses and sexually transmitted infections. The results will inform service commissioners (funders) on how to deliver a PrEP programme in the future, when PrEP will be made available as part of routine care in sexual health services.

The PrEP Impact Trial aims to answer key questions about the use of PrEP by groups at a higher need in England. The trial was announced by NHS England and Public Health England in a joint statement on 4th December 2016. The trial is planned to last three years and enrol 10,000 participants at high risk of acquiring HIV.

Whilst the efficacy of PrEP has been established in multiple trials across the world, including the PROUD trial that was conducted in England, the relatively small sample prevented the results being generalised to all sexually transmitted infection (STI) clinic attendees and left unanswered key questions about large-scale use of PrEP. The PrEP Impact Trial aims to address the outstanding questions about eligibility, uptake and length of use through expanding the assessment to the scale required to obtain sufficient data.

The trial is a pragmatic health technology assessment of PrEP and its implementation, that is, it aims to answer the key questions under real world conditions and at sufficient scale. In addition, the new trial will assess the impact of PrEP on new HIV diagnoses and sexually transmitted infections. The results will inform service commissioners (funders) on how to support clinical and cost effective PrEP access in the future.

A trial is necessary to address major questions that will determine effective future implementation of PrEP on a large scale. These questions are:

What proportion of those attending sexual health clinics will be at high risk and eligible for PrEP?
What proportion of those offered PrEP will accept it?
What is the length of PrEP use in those who accept the offer?
What is the impact on HIV incidence in the population?
What is the impact on STI incidence in the population?

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:

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

The trial is designed to address major questions that will determine effective future implementation of PrEP on a large scale. These questions are:

What proportion of people attending sexual health clinics will be at high risk and eligible for PrEP?
What proportion of people who are offered PrEP will accept it?
What is the length of PrEP use in those who accept the offer?
What is the impact on HIV incidence in the population?
What is the impact on STI incidence in the population?

The first clinics taking part in the PrEP Impact trial have now started enrolling participants. Different clinics will start enrolling at different times, and each one is working as fast as possible to get ready to start. Those wishing to get involved should visit the trial website to find out when their local clinic opens. As almost every sexual health clinic is taking part, you won’t need to travel to access the trial and you can receive all your sexual health care in the same place. Other than in exceptional circumstances, the design of the trial assumes participants will use their local service.

Around 70 clinics including those in London, Brighton, Manchester, Liverpool, Birmingham and Sheffield are expected to open recruitment in October and November. The remaining clinics across the rest of the country will follow closely behind over the coming months.

The trial will enroll 10,000 participants over the next three years. It has been estimated, based on best available evidence, that this may result in around 20,000 person years on PrEP. This is because some participants may use PrEP for a very limited time, whilst others may use it continuously for three years. This

is why the amount of time that PrEP is used by participants is one of the key questions to be answered by the trial.

Factors that may affect the total number of places on the trial (e.g. recruitment rate, amount of drug used, or any scientific developments) will be monitored by the trial management team throughout the lifetime of the trial. Any decision to amend the number of places would be taken by the Programme Oversight Board, which is responsible for governance of the trial.

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.

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

At the start of the trial in 2017 there were 10,000 participant places available across England; this target was based on the best available evidence at the time regarding who was eligible for PrEP amongst sexual health clinic attendees. In June 2018 an additional 3,000 places were added to the trial to adjust for the initial high recruitment observed across sites.

In early 2019 further review of study recruitment prompted a recommendation that the trial size be increased to 26,000 participants in total; this was agreed to by the Programme Oversight Board. Recruitment across the study has exceeded initial expectations and in order to properly answer the study objectives it was considered necessary to increase the number of places available.

Yes, these estimates are based on best available surveillance data of clinic attendance and will be tested during the trial.

It is one of the trial objectives to measure clinic throughput and in different regions; as such uptake across clinics is monitored as part of routine trial data collection. This information will be used to inform on patterns of use in updates to the Trial Steering Committee and PrEP Programme Oversight Board that is jointly chaired by Public Health England (PHE) and NHS England.

Based on planning assumptions, the trial will offer a reasonable opportunity for those assessed as meeting the eligibility criteria for the trial and willing to take it, to participate. However, it is important to remember that availability of PrEP is in the context of a clinical trial with 10,000 participants which has been designed to answer important research questions to inform future commissioning and rollout plans.

The trial is conducted in sexual health clinics across England. All specialised genitourinary medicine (GUM) clinics (i.e. level 3 sexual health clinics) have been invited to participate in the trial.

The PrEP Impact trial website includes a list of trial sites that are enrolling participants. This is updated regularly to reflect clinic status (open/paused) in relation to places available for gay and bisexual men having sex with men (MSM) and for women and other people.

Trial sites are required to meet a number of criteria to be able to participate in the trial, including:

Adequate capacity to deliver the sexually transmitted infections (STI) and HIV testing
Systems in place to prescribe and dispense PrEP
Systems in place to record and report trial data in a timely fashion

The planning of the trial has been led by PHE and NHS England. The trial is overseen by the PrEP Programme Oversight Board that is jointly chaired by PHE and NHS England. The Programme Oversight Board was convened in January 2017 and now has representation from the Association of Directors of Public Health, Local Government Association, the English HIV and Sexual Health Commissioners Group (EHSHCG) and the community (there are three lay-representative members).

The trial team actively engaged with clinicians and community groups in planning the trial. There were a series of meetings, convened by PHE, of the Task and Finish Group and Community Advisory Board. The Community Advisory Board was comprised of community representatives from across England and co- chaired by Public Health England and the National LGBT Partnership.

The Community Advisory Board was originally designed to achieve participation before the trial and so was temporarily disbanded, but has since been re-formed to provide advice to the Trial Management Group as the study continues. Membership includes members from the following groups:

Africa Advocacy Foundation (AAF)

African Eye Trust

African Health Policy Network (AHPN)

BHA (Black Health Agency) for equality in health and social care

cliniQ CIC

GMFA – the gay man’s health charity

i-Base

LGBT Foundation

London School of Hygiene and Tropical Medicine

NAM (National AIDS Manual)

National Aids Trust (NAT)

National Ugly Mugs

NAZ Project

Porn for PrEP UK

Positively UK

PrEPster

Sophia Forum

Spectra CIC and GMI Partnership

Terrence Higgins Trust (THT)

UK Community Advisory Board

Yorkshire MESMAC

The trial is designed to measure how many people at high risk of acquiring HIV will take up the offer of PrEP, and so will focus on:

men who have sex with men (MSM);
trans men and trans women;
HIV-negative partners of individuals diagnosed with HIV who are not known to be virally
suppressed;
heterosexual people who are considered to be at high risk of HIV acquisition.

A clinical risk assessment will be conducted at the GUM clinic.

The eligibility criteria for the trial are based on the criteria published by NHS England as part of the consultation on the draft commissioning policy proposal in August 2016. They were developed in discussion with clinical colleagues who participated in the Public Health England (PHE) PrEP Task and Finish Group and community representatives who participated in the Community Advisory Board convened by PHE.

PrEP will be offered to individuals considered to be at high risk of HIV acquisition. Three groups of individuals have been identified and the eligibility criteria set to match this.

a) MSM or trans women who currently test HIV negative, who also tested HIV negative earlier in the previous 12 months, and who report unprotected sex in the previous three months and consider they are likely to have unprotected sex (excluding oral sex) in the next three months.

b) The HIV negative partner of someone with diagnosed HIV, who is not known to be virally supressed and with whom unprotected sex is anticipated.

c) HIV negative people who are clinically assessed and considered to be at similar high risk of HIV acquisition as those with a partner with HIV who is not known to be virally suppressed. In other words someone who doesn’t fall into the criteria set out in a or b but whose situation is assessed to be at a similar level of risk.

This means that any of the following persons may be eligible for PrEP.

A woman or man reporting sex without a condom with partner(s) from countries with a high prevalence of HIV and intending to continue doing so
A female sex worker reporting inconsistent use of condoms with clients from countries with high prevalence of HIV
A transgender woman who has sex with men, reporting a recent history of condomless sex and intending to continue doing so

Trial participants must be aged 16 years or over. Whilst there may be individuals under the age of 16 at high risk of acquiring HIV, the ethics of research mean that it is not possible to include these participants. Such scenarios would raise questions regarding safeguarding that would require appropriate action.

This is a large-scale trial in order that sufficient data are generated to give certainty to commissioners to inform future commissioning of PrEP. Whilst PHE and NHS England are fairly confident that a significant proportion of those at highest risk of HIV acquisition will be eligible and enrolled, the trial has an upper limit of 10,000 participants. This means that it is possible that some eligible populations may not be able to access PrEP on the trial if it is already fully recruited.

The trial will be conducted in sexual health clinics in England. All specialised genitourinary medicine (GUM) clinics (i.e. level 3 sexual health clinics) will be invited to participate in the trial. The aim is to engage as many of the 230 or so clinics as possible, both in urban and rural locations, to ensure the trial coverage is widespread and access is equitable.

Clinics participating in the trial will open to recruitment in a phased approach over a few months. It is not possible to open all sites at exactly the same time and that means that some clinics will open a few months before others. If your local clinic opens slightly later, you will still have the opportunity to join the trial. Different clinics will be ready to start at different times and the rate at which trial sites will open will be dependent on the speed at which clinics can get local approval and put systems in place to train staff and capture trial data. The PrEP Impact trial website (when available) will include a list of trial sites that are enrolling participants. This is a key area that we will continue to update on through future communications.

Yes, these estimates are based on best available surveillance data and will be tested during the trial. The numbers will be shared with local authorities to allow them to plan for the trial in their area.

Each trial site will initially be allocated a ring-fenced number of participants. These places on the trial are based on the current numbers of potentially eligible participants that attend GUM clinics across the UK. Recruitment will be regularly monitored by the Trial Management Group, including which population groups are being recruited. Community groups, through representation on the Community Advisory Board (CAB), Trial Management Group, and Trial Steering Committee will be kept informed of recruitment demographics and numbers.

If certain population groups at equivalent high risk of HIV are under-represented in recruitment, we will work through the CAB to encourage under-represented groups to enrol in the trial. Places will be re-allocated across sites if required to ensure equity between different HIV high-risk groups.

It is important that you only enrol at one clinic. If you sign up at more than one, you may be taking a place on the trial that could have gone to someone else. It could also jeopardise the trial being able to capture all the information it needs to answer key questions.

If you need to transfer to another clinic during the trial (for example, if you move to a new town or city) then you will need to speak to your original trial clinic. They will arrange for the necessary information and papers to be given to the new trial clinic.

The treatment pathway for participants is set out below. Clinic attendees who are part of groups at high HIV risk are expected to be individually risk-assessed when they attend. Those who are eligible for, and accept the offer of PrEP will initially be prescribed PrEP for three months, either on a daily dosing or event based regimen, depending on their risk profile. Daily dosing is when PrEP is taken on a daily basis. Event based dosing is when PrEP is taken before having sex.

For new PrEP users it is good practice to follow-up after one month to check adherence. This can be by phone, email, or in person if required. After the first month, and for existing PrEP users, participants will be advised to return to the clinic at three month intervals, in order to re-assess continued eligibility and effectiveness.

All clinical care provided to participants will be in line with clinical guidance for PrEP or established clinical practice for the off-label use of these medicines. Participants will be offered PrEP as part of an active risk reduction intervention, including health education and safer sex promotion, to reduce and modify high risk behaviour. This may include the provision of free condoms, behaviour change interventions, other biomedical interventions such as post-exposure prophylaxis where relevant, the diagnosis and treatment of sexually transmitted infections (STIs), and regular HIV testing.

The planning of the trial has been led by PHE and NHS England. The trial is overseen by the PrEP Programme Oversight Board that is jointly chaired by PHE and NHS England. The Programme Oversight Board was convened in January 2017 and now has representation from the Association of Directors of Public Health, Local Government Association, the English HIV and Sexual Health Commissioners Group (EHSHCG) and the community. There is an interim lay-representative while we recruit two new lay members to the board.

We have actively engaged with clinicians and community groups in planning the trial. There have been a series of meetings, convened by PHE, of the Task and Finish Group and Community Advisory Board. The Community Advisory Board was comprised of community representatives from across England and co- chaired by Public Health England and the National LGBT Partnership.

Membership included:

African Health Policy Network
National AIDS Manual
UK Community Advisory Board (UK-CAB)
Yorkshire MESMAC
National AIDS Trust
Terrence Higgins Trust
BHA for Equality
PrePSTER
ClinicQ
NAZ
Sophia Forum
Spectra/GMI Partnership
Porn for PrEP UK
African Eye Trust

The Community Advisory Board was designed to achieve participation before the trial and so has been disbanded but is being re-formed to provide advice to the Trial Management Group. The most recent meeting of the Community Advisory Board on 29 June 2017 began the transition to the PrEP Impact Trial Community Advisory Board.

The PHE PrEP Task and Finish group included representatives from the following organisations:

British Association for Sexual Health and HIV (BASHH)
British HIV Association (BHIVA)
Sexual Health Commissioner from a London Local Authority
Sexual Health Commissioner from a non-London Local Authority
NHS England – Policy
NHS England – Clinical
Association of Directors of Public Health
Local Government Association
Public Health England Centres
Medical Research Council
St Stephen’s AIDS Trust

The Task and Finish Group has now been disbanded. Clinical input into the trial will continue through the Trial Management Group, the independent Trial Steering Committee and the PrEP Programme Oversight Board.

A formal Official Journal of the European Union (OJEU) procurement process was followed and interested parties were invited to submit applications to provide the drug. NHS England confirmed the award of a contract on 3 August 2017.

The PrEP trial has been designed as a medicinal product assessment of emtricitabine and tenofovir disoproxil in combination which falls within an exemption in the UK Patents Act. This has allowed a competitive procurement, inviting generic suppliers and the branded manufacturer to consider participating in the trial.

St Stephen’s Clinical Research and Public Health England have jointly sent out a letter to all sexual health clinics in England asking them to confirm their participation in the trial. This addresses the financial and logistical implications of participating in the trial and will allow clinics and their commissioning organisations (Local Authorities) to make the local decision as to whether they can accommodate the trial.

Once the trial team have received responses from each clinic, they will be able to send through all the relevant documents to begin the local formal approval process. Each site will need to issue an approval confirming capacity and capability before they can begin recruiting participants. As well as making sure the clinic has enough resource to run the trial, they will also need to receive trial-specific training to ensure they are appropriately trained to carry out the study tasks. The trial team will work with clinics to ensure this process is as quick as possible.

In July 2018 the legal responsibility and management of the trial moved from St. Stephen’s AIDS Trust (SSAT) and St. Stephen’s Clinical Research (SSCR) to Chelsea and Westminster NHS Foundation Trust. This was due to the planned closure of SSAT/SSCR.

This change of sponsorship had no impact on current or potential trial participants at trial sites. Amendments to the study were administrative between SSAT/SSCR and Chelsea and Westminster. If already enrolled on the trial, all participants were able to continue to access PrEP and attend their follow-up visits.

You can read about the change of sponsorship here.

The eligibility criteria for the trial are based on criteria published by NHS England as part of the consultation on the draft commissioning policy proposal in August 2016. They were developed in discussion with clinical colleagues who participated in the Public Health England (PHE) PrEP Task and Finish Group and community representatives who participated in the Community Advisory Board convened by PHE.

PrEP will is offered to individuals considered to be at high risk of HIV acquisition. Three groups of individuals have been identified and the eligibility criteria have been set to match this.

a) HIV-negative MSM and trans women who report condomless sex in the previous 6 months and on-going condomless sex.

b) HIV-negative individuals having condomless sex with partners who are HIV positive, unless the partner has been on ART for at least 6 months and their plasma viral load is <200 copies/mL.

c) HIV-negative individuals who are clinically assessed and considered to be at similar high risk of HIV acquisition as those described in category B above.

For example, this means that any of the following persons may be eligible for PrEP:

A woman or man reporting sex without a condom with partner(s) from countries with a high prevalence of HIV and intending to continue doing so.
A female sex worker reporting inconsistent use of condoms with clients from countries with high prevalence of HIV.

Trial participants must be aged 16 years or over. Whilst there may be individuals under the age of 16 at high risk of acquiring HIV, the ethics of research mean that it is not possible to include these participants.

If you are under 16 and think you might be at risk please attend your local sexual health/GUM clinic or speak to your GP or a trusted adult.

Any person assessed as being at high risk of acquiring HIV by meeting the eligibility criteria outlined above may join the trial. In order to reach a significant proportion of those at highest risk of HIV acquisition, and in response to the higher than expected levels of enrolment to the trial, the number of places was increased to 13,000 in 2018, and then to 26,000 places in 2019.

Recruitment is regularly monitored by the Trial Management Group, including which population groups are being recruited. Community groups, through representation on the Community Advisory Board, Trial Management Group, and Trial Steering Committee are kept informed of recruitment demographics and numbers.

If certain population groups at equivalent high risk of HIV are under-represented in recruitment, we work through the CAB to inform and encourage those under-represented groups to enrol in the trial.

People attending a clinic, who are part of groups at high HIV risk, will be asked about their individual circumstances to assess their potential risk. Those who are eligible for, and accept the offer of PrEP will initially be prescribed PrEP for three months, to be taken either every day or event based, depending on their circumstances. . Event based dosing is when PrEP is taken before and after having sex.

For new PrEP users (and those who have never taken PEP, post exposure prophylaxis) they will have a one month follow-up to check for any difficulties or problems they may be experiencing, and to answer any questions. This can be by phone, email, or in person if required. After the first month, and for existing PrEP users (and past PEP users), participants will be advised to return to the clinic at three month intervals, to test for HIV and screen for other STIs, and to check they wish to continue to use PrEP.

All clinical care provided to participants is in line with clinical guidance from BHIVA/BASHH for PrEP [https://www.bhiva.org/PrEP-guidelines]. Participants are offered PrEP as part of an active risk reduction intervention, including health education and safer sex promotion, to reduce and modify high risk behaviour. This may include the provision of free condoms, behaviour change interventions, other biomedical interventions such as post-exposure prophylaxis where relevant, substance misuse interventions, the diagnosis and treatment of sexually transmitted infections (STIs), and regular HIV testing.

It is important that you only enrol at one clinic. If you sign up at more than one, you will be taking a place on the trial that could have gone to someone else. It could also jeopardise the trial being able to capture all the information it needs to answer key questions.

If you need to transfer to another clinic during the trial (for example, if you move to a new town or city) then you will need to speak to your original trial clinic and advise them of your plans. At your first visit to the new clinic you will need to provide your original trial ID (if you do not know this, contact your original clinic and they can provide the number). You will be issued a new trial ID and registered as a participant at the new site. We recommend you take a photo of your consent form and trial ID and keep it on your phone in case you need it in the future.

In February 2019 the trial received ethics approval on an amendment to add an additional 13,000 places. These are currently being rolled out at participating sites across England. The list of clinics open to recruitment is being updated regularly:

https://www.prepimpacttrial.org.uk/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

The Mags Portman PrEP Access Fund supports people with no income or in receipt of benefits to access PrEP

https://www.tht.org.uk/our-services/online-services/mags-portman-prep-access-fund

PrEP Impact FAQs

1. Is the PrEP Impact Trial still running?

1. Can I stop taking my daily PrEP?

What is HIV PrEP?

What is HIV PrEP?

2. Does PrEP prevent or treat COVID-19?

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

What is the PrEP Impact Trial?

What is the PrEP Impact Trial?

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

Why is a trial needed?

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

Why is a trial needed?

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

When did the trial start and how long will it last?

4. How can I safely restart PrEP?

When will the trial start?

What is meant by 10,000 participants? "

5. What if I contract COVID-19?

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

How many people are on the trial?

Does the trial team have an idea of the number of people they expect to recruit from each area, and how are places allocated?"

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

Will there be enough PrEP available for those who wish to participate in the trial?

Will a proportion of participants on the trial be given a placebo?

Where does the trial take place?

How will individuals be able to access PrEP in the trial?

Who has been engaged in planning this trial and have community organisations been involved?

Who will be eligible to take part in the trial, and how will participants be identified? "

Has the trial received ethical approval?

What are the eligibility criteria?

Will all eligible populations be able to participate in the trial?

How can I find out more about the PrEP Impact trial?

Will it be 10,000 participants all followed for three years? Around 3,000 each for one year, or another scenario? "

How are individuals able to join the trial?

Where will the trial take place?

Does NHS England/PHE have an idea of the number of people they expect to recruit from each area, and how will places be allocated? "

Does a person’s nationality or immigration status affect whether they will be able to participate in the trial?

Do I have to visit the same clinic throughout the whole trial, or can I enrol at more than one? "

What is the suggested treatment pathway for those who enrol in the trial?

What are the requirements for sexual health clinics to sign up as a trial site?

Who has been engaged in planning this trial and have community based organisations been involved?

The cost of funding ‘all aspects of the trial’ is put at up to £10m. Does this include the cost of the drug itself?

Why has NHS England undertaken a competitive drug procurement for PrEP?

How are clinics preparing for the trial?

What happened to St Stephen’s Clinical Research?

Has the trial received ethical approval?

How can I find out more about the PrEP trial?

Where do I find information about the trial and the study drug?

What are the eligibility criteria?

Are all eligible populations able to participate in the trial?

Does a person’s nationality or immigration status affect whether they are able to participate in the trial?

Will a proportion of participants on the trial be given a placebo?

What is the suggested pathway for those who enrol in the trial?

Do I have to visit the same clinic throughout the whole trial, or can I enrol at more than one?"

What happens if I join the trial and then no longer need or want to take PrEP?

Where can I learn more about taking PrEP, possible side effects, dosing, etc?"

I didn’t get on the trial, what do I do now?"