PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men
A pilot study to determine the feasibilty of a larger trial assessing the clinical and cost-effectiveness of including anti-retroviral pre-exposure prophylaxis (PrEP) in the HIV risk reduction package for men who have sex with men who are at risk of acquiring HIV in the UK
What is this study about?
This study is looking at a new way to reduce the risk of catching HIV – Truvada-PrEP.
To find out whether a daily tablet, Truvada, can safely reduce the risk of gay men catching HIV, we need to do a large trial in which half the men do not receive Truvada for one year. We do not know if gay men at risk of HIV are interested in taking Truvada, and if they are, whether they would be willing to wait a year before they can take it. The reason it may not be safe, is that taking Truvada-PrEP may lead to an increase in risk behaviour. This could mean there was more chance of catching HIV and other infections.
As well as finding out if a large trial would be possible, this study will looks at other factors including:
- Whether people using PrEP change the number of partners they have sex with
- Whether people using PrEP change how often they use condoms
- Whether PrEP leads to higher rates of other sexually transmitted infections (STIs).
This information on changes in sexual activity over time is one of the most important aspects of the study, because we have never collected this before in the UK. This means we don’t know what happens to people’s sexual activity without PrEP!
Type of study
Who is funding the study?
The pilot is funded through a variety of sources including MRC CTU and the Health Protection Agency. An application to the Clinical Research Network for adoption of this phase of the trial into the portfolio has been made and accepted. Drug and support for protocol specific procedures and laboratory tests has been provided by Gilead for the pilot.
When is it taking place?
Nov 2012 to Apr 2016.
Where is it taking place?
PROUD is taking place at 13 Clinics:
• Birmingham (Heartlands)
• London, Mortimer Market
• London, Barts/Royal London
• London, St Marys
• London, Chelsea & Westminster
• London, Kings College Hospital
• London, Dean Street
• London, St Thomas’s
• London, Homerton
• Manchester (Centre for Sexual Health)
• Sheffield (Royal Hallamshire)
• York (Monkgate)
Who is included?
People who are born to male gender, age 18 years or more, reporting unprotected anal intercourse, able to take Truvada and not needing treatment for Hepatitis B.