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<p>NHS England will enrol 10,000 participants over three years at clinics across the
country in the pre-exposure prophylaxis (PrEP) IMPACT trial. The trial will provide
data on implementation of PrEP and its impact on HIV transmission among high-risk
groups, not those at any risk.</p><p> </p><p>Individuals for enrolment to the trial
will be assessed against inclusion and exclusion criteria in order to target those
at high risk of getting HIV and therefore most likely to benefit. National Health
Service funded access to PrEP drugs is only available through the IMPACT trial.</p><p>
</p><p>NHS England and Public Health England have been actively supporting the PrEP
IMPACT trial sponsor in accelerating ethical approval and trial site recruitment.
It was not possible to complete all the necessary steps to achieve a September 2017
start because of the large number of trial sites. Trial sites have to assure the trial
co-ordination centre has ethical approval, drug procurement, trial site feasibility
assessments, trial site training, local commissioner approval and local research governance
approval in place before permission to recruit is given. This is dependent on local
processes and is variable. Trial opening dates will be staggered to reflect this.</p><p>
</p><p>The first clinics began be enrolling patients in October and a number of clinics
will be opening within weeks of each other, both in and outside London. The trial
sponsor anticipates that up to 70 sites will be enrolling patients by the end of November.
All clinics should be enrolling patients by April 2018.</p><p> </p><p>As the largest
single study of its type in the world, the PrEP trial is complex, involving well in
excess of 100 organisations ranging from sexual health clinics, local authority commissioners,
research bodies, and a drug manufacturer. The aim is to ensure multiple clinics across
the country can provide geographical access and avoid surges to individual clinics.
As trial sites open, information will be uploaded to the trial website enabling individuals
who wish to participate in the trial to identify their nearest local clinic.</p><p>
</p><p>Of the 10,000 trial places, an initial 2,000 places are being reserved for
groups at high HIV risk other than gay men. The trial co-ordinating team will monitor
PrEP uptake and keep this initial ring-fence under review.</p><p> </p><p>Further information
on the trial can be found at the following link:</p><p> </p><p>https://www.prepimpacttrial.org.uk/</p>
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