HIV Infections Clinical Trial
Official title:
PrEP Impact Trial: A Pragmatic Health Technology Assessment of PrEP and Implementation
HIV pre-exposure prophylaxis (PrEP) is the use of anti-HIV medicines by HIV negative people
in order to prevent them from becoming HIV positive if exposed to HIV.
Currently, the combination drug containing tenofovir and emtricitabine is licensed in Europe
for use as HIV PrEP. We know from previous studies worldwide that this combination drug is
very good at reducing the risk of HIV infection and several countries have implemented PrEP
programmes to provide PrEP to individuals at high risk of HIV.
However, it is difficult to effectively plan for a national PrEP programme in England without
knowing how many people will need PrEP, how many will want to take PrEP, and how long they
will stay on PrEP.
In order to find this out, the PrEP Impact Trial will make PrEP available to at least 10,000
people over three years. HIV negative men and women attending sexual health clinics in
England will have their risk of HIV assessed by their care team and be offered PrEP if they
meet the eligibility criteria. Through the trial we will be able to measure how many
attendees at sexual health clinics meet eligibility criteria for PrEP, how many of these take
up the offer of PrEP and how long they remain on PrEP for.
There will not be any additional tests other than those recommended for the safe delivery of
PrEP. These include tests for sexually transmitted infections (STIs) and HIV as well as urine
and blood tests to monitor kidney function. Information about attendances and test results
will be anonymously collected through the existing data reporting system that sexual health
clinics currently use to report to Public Health England.
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