PROUD Participant Involvement Meeting 12 th November 2013

1. PROUD Participant Involvement Meeting 12th November 2013

2. Background • Concerns about widespread use of PrEP in the UK include cost, not only of drug but the feasibility of delivering it, the emergence of drug resistance, toxicity, and the possibility that people will drift away from consistent condom use, outweighing any protection offered by PrEP. • “It is imperative to gather evidence for the value of PrEP in the UK, in order to achieve universal access should it prove cost effective as part of a combination prevention package”. • To collect evidence on effectiveness of PrEPit would be necessary to conduct a large clinical study involving about 5,000 gay men. • PROUD pilot study aims to find out if gay men would be interested in joining a PrEP study of this design. • Plan to enrol 500 gay men to the pilot study, to be able to see if it would be feasible to conduct a very large study of about 5,000 gay men in England using the same study design.

3. Current Situation • First clinic started recruiting in November 2012 and the 13th clinic started recruiting in July 2013. • Had expected that about 500 men would have joined the study by now (November 2013), but only 320 have joined. • We have already agreed to extend the recruitment period until 31st January 2014, but in the best case scenario expect about 440 men to have joined the study by then.

4. Future Options – option 1 • Continue as planned: End recruitment to the pilot study at the end of January 2014 and continue to follow-up each enrolled man for 2 years; • Pro: We will be on track to apply for funding to conduct a larger trial. • Con: We will not have convincing evidence about the value of PrEP in the UK based on this pilot study alone. Given recruitment to the pilot study has been so slow, we can not be confident we would attract funding to conduct another larger study.

5. Future Options – option 2 • Extend the pilot study: Continue enrolling for at least another year until over 1,000 men have joined the pilot study; • Pro: Given the size of the study, the evidence would not be conclusive and findings could be due to chance. However, if no one acquired HIV while using PrEP we could have clinically convincing evidence to call for access to PrEP in the NHS. • Con: If an equal number of men acquire HIV while using PrEP to those not using it, we could under estimate the value of PrEP in the UK and undermine efforts to make PrEP available in the NHS.

6. Future Options – option 3 • Trial: We could continue the pilot as planned and apply next year for funding to conduct a large scale trial; • Pro: A large clinical trial would give conclusive evidence about the value of PrEP in the UK and would be powerful evidence to support access to PrEP in the NHS if PrEP is shown to add value. • Con: Based on the numbers of men who volunteered for the pilot study, it would take a number of years to enrol 5,000 men to a study. This could make getting funding difficult, but could also delay access to PrEP in the UK.

7. Discussion Points • Why have fewer men than expected joined the PROUD pilot study? • What are the best next steps for PrEP in the UK? • How important is it to ensure access to PrEP for men once they complete their two years in the study?