One way of getting any kind of innovative medicine is through a trial or study.
There are two kinds of trials of a new medicine – randomised trials and implementation studies, also known as demonstration studies.
For PrEP, in a randomised trial, PrEP is being compared to some other alternative prevention method, or to a new drug to see if it works as PrEP. These days, because we know Truvada-based PrEP works, you will not be asked to join a randomised trial where no form of PrEP is available. A randomised trial will probably compare Truvada PrEP with some other kind of experimental PrEP. This may work better than, just as well as, or worse than Truvada.
The DISCOVER trial is a large, randomised, international trial to see how a newer form of Truvada, called Descovy, compares against Truvada as PrEP. In Europe, there are trial sites in seven countries but it is now fully recruited. While we know Descovy works as treatment for HIV, we have no proof it will work as well as Truvada for PrEP; the purpose of the trial is to find out if it will.
In an implementation trial, everyone gets standard and effective PrEP. An implementation trial does not test effectiveness, but rather how best to deliver PrEP to those in most need of it. The trial may ask: how does PrEP affect the overall rate of HIV infection? Can it be offered efficiently and without undue cost? Does giving people PrEP affect their risk of acquiring other sexually transmitted infections? Will demand be higher or lower than expected?
Several countries have decided to run large or small implementation trials before making PrEP a standard part of their health service.
Ongoing and planned trials
All PrEP trials currently (July 2017) underway in western Europe are full, i.e. no longer recruiting, with one exception.
Wales is that exception: on 17 July 2017, the Welsh Health Service began recruiting people to PrEPared in Wales, an implementation trial for the region. PrEPared in Wales hopes to recruit 500 participants and will run for three years. (Wales, like Scotland, which already offers PrEP, has its own health service, independent from the other countries in the UK.)
England is about to start a large implementation trial, IMPACT, with 10,000 participants. IMPACT is essentially a trial of the health system’s ability to provide PrEP efficiently and economically. It should start in August 2017.
Smaller implementation trials are planned for other countries in Europe.
In Greece, the SOPHOCLES study is researching the need for PrEP among the population of men who have sex with men (MSM) and based on the findings from this sociological study will then recruit 100 MSM at high risk of HIV into a demonstration project called P4G.
In Spain, a national protocol has been drawn up, but each autonomous region is expected to run and fund the trial, and so far, only Catalonia and the Basque provinces have indicated interest.
In central Europe, Slovenia is planning a trial to start later this year, Croatia in early 2018, and Romania has announced it will try to implement PrEP next year. None of these trials are guaranteed, as there are still funding and administrative barriers to overcome.
In Ukraine, in eastern Europe, a trial of PrEP among 100 at-risk people, funded partly by PEPFAR in partnership with UNAIDS and the Alliance for Public Health, is due to start in August or September in Kyiv.
In Georgia, a 100-person trial among MSM is planned, to start in late 2017. It will be run jointly by the Infectious Diseases, AIDS and Clinical Immunology Research Center of Georgia, and the LGBT NGO the Equality Movement.
PrEP in Europe will try to collect updated trial information and post it in our country pages. Please email us or post on our Facebook page if there is a trial going on in your area that should be publicised.