Transcript Testing as prevention - Medical Research Council

PROUD
Participant Involvement Meeting
12th November 2013
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 PrEP it 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.
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.
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.
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.
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.
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?