top of page
A pragmatic health technology assessment of PrEP and implementation
PrEP Impact FAQs
THE PREP IMPACT TRIAL IS NOW CLOSED TO NEW PARTICIPANTS!
If you need PrEP and are not on the trial, please ask your clinic if they have PrEP available through the new commissioned service.
For other alternative ways to access PrEP in the UK see http://i-base.info/guides/prep/introduction-and-access
The PrEP Impact Trial has been running in sexual health clinics across England since September 2017. For any questions regarding the trial and study drug please first refer to the Participant Information Sheet.
Since the start of the study there have been changes to the trial sponsorship, increases to the number of study places, and updates to the trial protocol. The FAQs below have been updated to reflect the current status of the trial; questions that have been archived can still be accessed here.
Yes. The trial has stopped recruiting participants and is in the follow-up phase until 12th October 2020. 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 Regulatory Authority (HRA), using their guidance for conducting research under COVID-19 planning.
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.
Pre-exposure prophylaxis, or PrEP, is a way for people who do not have HIV, but who are at substantial risk of HIV infection to reduce their risk of acquiring HIV. This involves taking the PrEP drug as instructed, prior to any exposures that might put the individual at high risk of getting HIV. The single-tablet PrEP drug contains two medicines (tenofovir and emtricitabine).
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.
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)(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.
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.
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(http://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.
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?
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.
The trial started enrolling participants in October 2017 and is intended to continue recruiting new participants to mid July 2020. Different clinics have opened to participants at different times. As the majority of sexual health clinics are taking part, you should not need to travel far to access the trial and you can receive all your sexual health care in the same place.
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.
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/(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(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(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.
If you need PrEP and are not on the trial, please ask your clinic if they have PrEP available through the new commissioned service.
For other alternative ways to access PrEP in the UK see
http://i-base.info/guides/prep/introduction-and-access(http://i-base.info/guides/prep/introduction-and-access)
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.
Absolutely not. Every single person who takes part in the trial will be given PrEP. A placebo (dummy pill) group is not required as this trial is not about whether the drug is effective – there is already sound evidence to show that it works.
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 (javascript:void(0))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
PrEP will be offered to individuals attending participating genitourinary medicine (GUM) clinics, who meet the trial criteria and consent to participate.
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 Trial received ethical approval in early August 2017. Further approvals were given in July 2018, and February 2019 for the increases to the number of places.
The reference numbers for the PrEP Impact Trial are: REC reference 17/LO/1134; IRAS ID 228166.
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 best way to discuss PrEP and find out more about the trial is to visit your local participating clinic.
Further information can be found in the Trial Protocol (javascript:void(0))and the Participant Information Sheet,(javascript:void(0)) both of which can be found on this website.
The Prepster website (https://prepster.info/)(https://prepster.info/) also contains information on accessing PrEP in England.
Participants will be followed for as long as they are on PrEP. No limits will be placed on enrolment into the trial annually, unless the 10,000 participant level is reached. Participant enrolment into the trial will depend on uptake of PrEP by those assessed to be eligible
PrEP will be offered to individuals attending participating genitourinary medicine (GUM) clinics, who meet the trial criteria and consent to participate.
If you wish to join the trial, the best way is to contact one of the participating clinics. You can see a list and map of participating sites at: https://www.prepimpacttrial.org.uk/join-the-trial.(javascript:void(0))
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.
No, as long as they are ordinarily resident in England. Unlike some other NHS services, there are no immigration or nationality restrictions on accessing services provided by GUM clinics in England. This is because of the wider public health benefit of everyone being able to freely access sexual health treatment and prevention services and advice. The trial will follow the same principles.
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.
Trial sites will be required to meet a number of criteria to be able to participate in the trial, including:
• Adequate capacity to deliver the 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 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.
The £10m budget is for all aspects of the trial, including the drug.
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.(javascript:void(0))
The Trial received ethical approval in early August 2017.
For further information please contact your local sexual health clinic.
For any questions regarding the trial and study drug please first refer to the Participant Information Sheet:(javascript:void(0))
https://www.prepimpacttrial.org.uk/participant-information-sheet(https://www.prepimpacttrial.org.uk/participant-information-sheet)
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.
No, as long as they are resident in England. Unlike some other NHS services, there are no immigration or nationality restrictions on accessing services provided by GUM clinics in England. This is because of the wider public health benefit of everyone being able to freely access sexual health treatment and prevention services and advice. The trial follows the same principles.
No. Everybody who takes part in the trial will be given PrEP. A placebo (dummy pill, with no therapeutic effects) is not required as this trial is not about whether the drug is effective – there is already sound evidence to show that it works.
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.
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.
Deciding when to stop or restart PrEP should be discussed with a clinician at your trial clinic.
You may withdraw from the trial at any time for whatever reason; you will need to inform the clinic where you are registered.
You can also see the official product information here: https://www.ema.europa.eu/en/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-mylan
The Prepster website (https://prepster.info/) also contains information.
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
bottom of page