1 December 2015 On this World AIDS Day of 2015 we can celebrate a year of major successes in HIV prevention. Last week the French Ministry of Health was the first in Europe to authorise access to PrEP for populations most at risk of HIV infection. This decision was largely based on the results of the IPERGAY study who released their results in the New England Journal of Medicine today.
IPERGAY was the first trial to show that using PrEP around the time of sex offers equivalent protection to the daily dosing regimen.
10 September 2015
Results from the PROUD study, showing a daily pill can effectively protect people from HIV infection, were published today in The Lancet. PROUD is the first study of the pre-exposure prophylaxis approach to preventing HIV to be carried out in the UK. The results show the approach could play a major role in reducing the number of new infections among men who have sex with men.
Pre-exposure prophylaxis (PrEP) is a HIV prevention strategy that involves HIV-negative people taking antiretroviral drugs to reduce the risk of becoming infected if they are exposed to the virus. The PROUD study looked at whether offering daily PrEP to men who have sex with men was an effective way to prevent HIV infection. The results show that PrEP is highly protective, reducing the risk of infection for this group by 86%.
The drug used in the trial – the antiretroviral Truvada (usually used to treat HIV) – was already known to reduce the incidence of HIV infection in placebo controlled trials. The PROUD study was designed to see how good Truvada would be found as PrEP in a real world situation where participants knew they were taking an active drug. It aimed to address outstanding questions such as whether taking PrEP would change sexual risk behaviour – for example increasing the number of partners they did not use condoms with and increasing the rate of other sexually transmitted infections (STIs) – and whether or not it would be cost-effective to make it available on the NHS.
A total of 544 people from 13 sexual health clinics in England took part in the study. They were men who have sex with men, who reported having had anal sex without a condom in the previous 3 months. The study randomised participants to receive PrEP immediately or to receive PrEP after a period of 12 months, allowing researchers to compare those on PrEP versus those not yet on PrEP.
Only three men in the immediate PrEP group were infected with HIV, compared to 20 in the group who did not receive PrEP immediately. The three men who were infected in the immediate PrEP group were unlikely to have actually been taking PrEP when they were infected – one was probably infected before he started PrEP, and the other two had not collected their prescription of PrEP for several months before being diagnosed. There was no difference in the number of men diagnosed with other STIs between those on PrEP and those not on PrEP.
For more information about the PROUD study, watch the documentary which contains interviews with researchers, doctors, study participants and community groups.
The number of new HIV infections in the UK has remained stable over the last decade, with approximately 2600 men who have sex with men being newly infected in the UK each year. In order to reduce the number of new infections we need new approaches to preventing the disease, to add to the ones already in use. Adding PrEP to our existing HIV prevention approaches could have a major impact.
The results of PROUD have been welcomed by community organisations including the Terrence Higgins Trust and National AIDS Trust. They are now calling for PrEP to be made available on the NHS. NHS England are currently examining the totality of evidence to support a PrEP programme.
The PROUD study was led by the MRC CTU at UCL and Public Health England in partnership with 12 NHS trusts in England.
4 September 2015
PrEP can be purchased from a pharmacy with a private prescription from a registered medical professional.
Purchasing pharmaceuticals only from pharmacies registered with the General Pharmaceutical Council (GPhC) will help consumers to avoid counterfeit medicines. All pharmacies in Great Britain, including those providing interest services, must be registered with the GPhC.
The GPhC operates an internet pharmacy logo scheme to identify legitimate online pharmacies so that the public can be sure they are purchasing safe and genuine medicines online.
The GPhC Logo not only provides a visual means to help patients identify whether a website is connected to a registered pharmacy, but it will also provide a direct link to the GPhC website. By clicking on the GPhC Logo, visitors can verify the registration details of both the pharmacy and the pharmacist(s) behind the website. If you do choose to buy medicines over the internet, we suggest that you buy from a website that displays the GPhC logo and that you have verified the pharmacy is registered with the GPhC by clicking on the GPhC Logo.
In addition, when you are shopping for pharmaceuticals online, there are a number of signs that a particular pharmacy may not be reliable:
- The contact information available on the site is electronic only, and the site does not provide a physical address or a way to contact the web site by telephone.
- Its physical address is undisclosed or is outside the Europe. Orders placed with pharmacies identifying themselves as Canadian frequently will be filled by pharmacies located elsewhere in the world and will sell medicines which have not been approved for sale by either Health Canada or the MHRA.
- The website offers no secure way to leave your personal or credit card information.
- Prices on the site are dramatically lower than the competition. If the price of a medicine seems too good to be true, it probably is.
- The site requires no prescription for prescription drugs.
- The online pharmacy sells pharmaceuticals not approved for sale by the MHRA.
- When you receive your order, it bears a different brand name or manufacturer and has a different appearance than the medicine you ordered.
Medicines obtained from online pharmacies with one or more of these warning signs may not contain the active ingredients of the genuine product and thus be ineffective. Or, the medicines may contain entirely different active ingredients which may cause serious injury. In addition, pharmacies which are located overseas or which do not require a prescription have been known to be associated with organized crime and the personal and credit card information provided to the site may not be kept confidential or secure.
Q & As
Can I get PrEP privately in the UK?
Can I check PrEP from the internet is genuine?
How do I safely use PrEP if I buy it online?
24 February 2015
The PROUD study today reported that PrEP reduced the risk of HIV infection by 86% for gay and other men who have sex with men when delivered in sexual health clinics in England.
The PROUD study measured the effectiveness of daily PrEP for gay and other men who have sex with men in England. The results released at the Conference on Retroviruses and Opportunistic Infections today indicate that PrEP is highly protective for this group, reducing the risk of infection by 86%. The researchers concluded that PrEP offers a major opportunity to curb new HIV infections in men who have sex with men in the UK.
Withdrawn plans to expand Proud study
19 January 2015
Given that the PROUD pilot study has answered the important question of how much protection daily Truvada can offer when provided in sexual health clinics in the UK, there is no need for the planned larger clinical trial. As such, we have withdrawn our funding application to reopen the PROUD study for new recruitment.
In addition to daily Truvada, there is a range of other PrEP options in various stages of research. We are in the process of talking to our partner organisations in order to identify which PrEP research questions we should address next in the UK.
HIV charities update joint statement on PrEP
25 November 2014
A group of community organisations, including NAM, HIV Prevention England, the Terrence Higgins Trust, National AIDS Trust, Lesbian and Gay Foundation, GMFA and Yorkshire MESMAC, have updated their statement on PrEP following the recent announcements from the POROUD and IPERGAY studies. The statement calls for the NHS to speed up its processes and make pre-exposure prophylaxis (PrEP) available to those at the highest risk of acquiring HIV. To read the full statement click here.
Update on trial timelines
20 November 2014
In April 2014, we announced that we had applied for additional funding to expand the PROUD pilot study into a full trial and if successful, hoped to reopen for recruitment early in 2015. A number of volunteers have already added their names to clinic registers of people interested in PrEP so they can be informed if recruitment reopens.
In October 2014, an interim analysis of the PROUD pilot study data showed that pre-exposure prophylaxis (PrEP) is highly protective against HIV in the PROUD pilot study population. As a result, we changed the study design and offered all enrolled participants the opportunity to access PrEP.
Due to this exciting result, we need to change the design of the planned full trial, as it is no longer acceptable to include a year when participants have no PrEP. This means that we need to resubmit the application. The funders have indicated that they will speed up the review process, but there will still be a delay of several months. If we are successful, the earliest study recruitment could reopen would be 2016.
Volunteers are still welcome to register their interest in participating in future studies directly with PROUD clinics or via the PROUD email address (email@example.com) and we will aim to keep you up to date on the progress of the funding application via the PROUD website (http://www.proud.mrc.ac.uk/).
While the delay to the full trial is unfortunate, the early finding from the PROUD pilot study will help the Clinical Reference PrEP working group develop a policy on the use of PrEP in the UK.
PROUD Pilot Study Update
16 October 2014
An interim analysis of the PROUD study data has shown that pre-exposure prophylaxis (PrEP) is highly protective against HIV for gay men and other men who have sex with men (MSM) at high risk of infection. On this basis, the PROUD Trial Steering Committee has announced that participants currently on the deferred arm of the study, who have not yet started PrEP, will be offered the opportunity to begin PrEP ahead of schedule.
30 April 2014
All the study spaces are now filled!
Thank you to all those who have enrolled, the study teams and the community organisations who have worked together to achieve this.
Watch this space for updates – we have applied for additional funding to expand and if successful, hope to reopen study recruitment early in 2015.
Meanwhile, some participating clinics are keeping a register of people interested in PrEP so they can let you know if recruitment reopens.
20 March 2014
The PROUD pilot study now has 500 participants enrolled.
PROUD pilot study
The PROUD pilot study aims to assess the feasibility of conducting a clinical trial of PrEP among gay men and other men who have sex with men in the UK, using a design that randomises men to receive PrEP immediately as part of the HIV risk reduction package or to receive PrEP after a deferred period of 12 months. As of 10th February 2014, 451 men had enrolled in the PROUD pilot study and four of the thirteen clinics have suspended recruitment in order to manage the follow up visits. Recruitment will continue until we reach a minimum of 500 men enrolled, a maximum of 550 (10% over protocol) or all clinics reach capacity.
The PROUD Trial Steering Committee (TSC) met on 19th November 2013 to discuss the possibility of proceeding with an application to conduct a large-scale clinical trial using this study design. They reviewed data based on the enrolment of 324 gay men across 13 clinics in England. The TSC supported the Trial Management Group’s (TMG) request to submit an application for trial funding to the UK National Institute of Health Research (NIHR), Health Technology Assessment (HTA) researcher led call. An outline application was submitted on 6th January 2014.
In the PROUD trial application, we propose enrolling a further 1800 men to immediate or deferred start of PrEP. A total of 1800 participants, in addition to the data collected from 500 men in the pilot study (a total of 2300), allows the detection of a two-fold reduction in annual HIV incidence from 5% to 2.5% with 80% power at 5% level of significance, assuming a 15% rate of loss of follow-up. The network of 13 genito-urinary medicine (GUM) clinics involved in the pilot study, would be slightly expanded for the trial, which would run from 1st January 2015 to 30th June 2018. We are currently negotiating access to PrEP for all study participants until the last person exits the trial (or the last person exits the pilot study, if the trial is not funded). We will continue to involve participants and members of the Community Engagement Group (CEG) in the development of the trial application and protocol. The funding application is for a total of £2,287,366, with additional NHS support and treatment costs of £1,031,494. We expect to find out if the outline application has met the priority assessment by quarter 2 of 2014, if we are invited to submit a full application by quarter 3 of 2014, and the outcome of the application towards the end of 2014/early 2015 (date tbc). If successful, we will be able to seamlessly roll straight from the pilot study into the trial in the existing clinics, and expand into new clinics as required.
The TSC reviewed a range of other evidence regarding the feasibility of conducting a large-scale clinical trial in the UK. Initially the PROUD TMG anticipated recruiting 500 men within approximately 6 months (approximately 80 men enrolled per month). However, while the first clinic initiated recruitment in November 2012 it was not until July 2013 that all 13 recruitment clinics were operational. From July to December 2013, the clinics were recruiting an average of 40 participants per month. The TMG undertook a number of evaluations to explore the reasons for the recruitment rates being lower than expected, which are described below:
1. Recruitment survey: In June 2013, we conducted a survey among PROUD study staff to explore barriers and facilitators to recruitment. The survey highlighted that the main barriers to recruitment were a lack of study staff capacity, and insufficient numbers of eligible men being referred to the study clinics. In a subsequent review, it was clear that recruitment was generally higher in clinics that received support from the NHS Comprehensive Local Research Networks (CLRN) for dedicated research staff. From the PROUD study, clinics only receive £305 per participant enrolled (including 2 years follow-up) and few clinics are enrolling sufficient numbers of men to justify dedicated staff. The survey also highlighted that the main reasons for men not being interested in joining the study related to not feeling at sufficient risk of HIV or not being interested in additional HIV prevention options. Importantly for the feasibility of the PROUD trial, only 19% of staff said that men were not interested in joining the study due to the chance of being randomised to the deferred study arm.
2. Community Engagement Group (CEG) expanded meeting: In June 2013, the PROUD Community Engagement Group invited additional representatives from the UK’s leading HIV charities, gay media and dating websites. The meeting focused on discussing awareness about PrEP and interest in the PROUD study among gay men. It was thought that the level of awareness among gay men about PrEP and the PROUD study were extremely low. As a result of the meeting the UK’s leading HIV charities released a joint statement outlining their position on Pre-Exposure Prophylaxis (PrEP) – available at http://www.proud.mrc.ac.uk/news.aspx. There was continued support for the PROUD study design and the need to evaluate PrEP uptake and usage in the UK.
3. Knowledge, Attitudes and Practices survey: In September 2013, we conducted a survey of UK healthcare providers through sexual health clinics, professional societies’ email lists, and at a sexual healthcare conference. In total 328 healthcare providers responded, three-quarters of which were not involved with the PROUD pilot study. An abstract of the results has been submitted to the joint conference of the British HIV Association and British Association of Sexual Health and HIV (BHIVA/BASHH). Importantly for the feasibility of the PROUD trial, just under half of healthcare providers not involved in PROUD had been asked about PrEP by patients in the past year. This suggests a higher awareness among gay men than was proposed in the CEG expanded meeting or the participant involvement meeting described below, and highlights the need for further exploration of both the level of awareness and interest in PrEP among gay men in the UK.
4. Participant Involvement Meeting: We held the first participant involvement meeting with eight study participants on 12th November 2013 entitled ‘Future Options for PROUD’. In discussing why fewer men than expected joined the PROUD pilot study, the overall view was that slow recruitment was mainly due to not enough men being aware of PrEP or PROUD, not a result of men not being interested in PrEP or the PROUD study. In discussing the best next steps for PrEP in the UK, the overall summary was that we should not rush to broader roll out without understanding more about adherence and the impact of PrEP on sexual behaviour. All participants agreed that PrEP should only be available in dedicated clinics (like in PROUD) and supported plans for a larger clinical trial.
5. Recruitment to treatment trials: Before the TSC, the TMG compared the number of HIV negative men enrolled into PROUD on a monthly basis, to the numbers of HIV positive men enrolled into other studies conducted by MRC. The average enrolment in the other studies was 20 per month with substantially more clinics, highlighting that our original enrolment targets may have been overly ambitious.
For further details about the PROUD study, please visit our website at http://www.proud.mrc.ac.uk/ including the newly posted page on Patient and Public Involvement or contact the PROUD study team at PROUD@ctu.mrc.ac.uk.
Updated 10 February 2014 by Mitzy Gafos (firstname.lastname@example.org)
HIV charities release joint statement on PrEP
23 September 2013
A group of the UK’s leading HIV charities have released a joint statement outlining their position on Pre-Exposure Prophylaxis (PrEP).
PrEP is a promising new HIV prevention strategy that is currently being trialled in the UK. It involves people who do not have HIV taking a daily dose of one or two of the drugs that are used to treat HIV.
Studies suggest that this can prevent infection if the user is exposed to HIV.
Faced with continuing high rates of HIV transmission amongst gay men in the UK, the charities believe we need to see additional effective prevention options introduced, such as PrEP, so that more gay men are able to reduce their HIV risk.
Currently, Public Health England and the MRC Clinical Trials Unit are running a UK trial of PrEP, called the PROUD study, for gay and bisexual men who are at a high risk of HIV infection.
The group has created the statement in a bid to raise awareness around PrEP and provide gay and bisexual men with clear, accurate information. It covers why researchers are conducting a trial of PrEP in the UK, how effective it is, and under what circumstances PrEP could be used to reduce new infections. [view the full document]
The charities who collaborated on the statement are GMFA, the Lesbian and Gay Foundation, NAM, NAT (National AIDS Trust), Terrence Higgins Trust, and Yorkshire MESMAC.