NHS England has announced the start of a pioneering implementation trial to provide HIV prevention drugs to people at high risk of HIV infection.
From September, pre-exposure prophylaxis (PrEP) will now be provided by the NHS through the initial three year trial to an estimated 10,000 people, in what will be the largest single study of its type in the world. Whilst HIV infection rates in England are falling due to increased prevention, diagnosis and treatment programmes, this major new NHS-England funded intervention will now assess the full additional potential of PrEP, by gathering clinical evidence on optimal targeting, uptake and implementation on a large scale.
Sexual health clinics in London, Brighton, Manchester, Liverpool and Sheffield are expected to be amongst the first to start enrolling people in the impact trial from early September. More clinics will join in October with full implementation across England by April 2018 at the latest. As lessons are learned from the trial, this will inform follow-on routine commissioning subsequent to the three year trial.
To support the study, NHS England has now concluded a successful international competitive procurement to source the PrEP drugs for this trial. A contract signed this week has secured pricing consistent with the programme’s allocated budget of £10 million, which also includes on-costs for local authorities and sexual health clinics involved in delivering and monitoring the trial intervention.
Clinics will identify eligible participants who consent to the trial, including men, women, transgender people, and individuals who have a partner whose HIV status is not known to be controlled by anti-retroviral treatment. People living and registered with a GP in England will also be able to enrol for potential participation at their local participating sexual health clinic.
In addition to investing in the PrEP trial, NHS England already invests in a ‘treatment as prevention’ (known as TasP) policy to start HIV treatment earlier for people with diagnosed HIV to protect HIV-negative partners. This programme, combined with other prevention measures, has led to a drop of over 20 per cent in new HIV diagnoses in large London clinics.
Simon Stevens, Chief Executive of NHS England, said: “This major new intervention should complement and supercharge the wide-ranging and increasingly successful effort to prevent HIV. It’s another milestone in more than three decade’s worth of progress in tackling one of humanity’s major health challenges.”
Deborah Gold, Chief Executive at NAT (National AIDS Trust) said: “This is a pivotal moment in the fight against HIV. PrEP, if targeted properly at those in need and at risk, offers the possibility of transforming the English HIV epidemic. From September, people at high risk of HIV will have access via this NHS funded trial in England to an empowering new tool that is truly individually controlled and not subject to negotiation with a partner, leading to the improvement of many, many lives. We warmly welcome this announcement.”
Ian Green, Chief Executive of Terrence Higgins Trust said: “We’re pleased that NHS England has announced a start date for the much anticipated PrEP trial. This trial has been gaining momentum in England, and is vital as we work towards ending HIV transmission. The priority must now be to make sure that the trial is rolled out speedily across the country, and that no-one at risk of HIV is left behind. Now that the PrEP trial drug has been procured, we’re well on the way to protecting over 10,000 people at risk of HIV.”
Professor Brian Gazzard, Consultant in Infectious Diseases, Chair of St Stephen’s AIDS Trust and Chief Investigator for the PrEP Impact Trial, said: “This is a hugely important and ambitious trial, and one which we need if we are to accurately translate the promising findings of the PROUD pilot study to a wider risk population. There is a more diverse population of high risk individuals for whom PrEP and its associated risk reduction support could mean the difference between staying HIV negative or becoming HIV positive. The data and evidence we generate will not only be of international interest but more importantly will enable commissioners in England to plan for a PrEP programme that benefits individuals and the taxpayer.”
Nick Phin, Deputy Director of National Infections Service at PHE, said: “The trial will provide insight into how PrEP is used across the country. We are working closely with the group who is running the trial and will be collecting data and supporting with understanding usage across the country.”
Health Minister Steve Brine MP said: “This trial will not only change the lives of those who participate, but it will give us further evidence on how we can use PrEP in the long-term fight against HIV – building on the good progress we have already made.”
Greg Owen co-founder of iwantPrEPnow, said: “iwantPrEPnow welcomes the news that IMPACT will start recruiting in September and will fully support NHS England and PHE to make the trial as accessible and equitable as possible. This is most certainly a step in the right direction and we would like to see all clinics onboard before 2018.”
Dr. Will Nutland co-founder of PrEPster said: “PrEPster applauds the commencement of the IMPACT trial. International evidence on PrEP clinical efficacy is now so compelling that access to PrEP through the trial will have a significant impact on HIV in England. PrEPster will work alongside our colleagues for swift implementation across the country, and for diverse recruitment to the trial.”
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