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 was 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 is a higher chance of catching HIV and other infections.

As well as finding out if a large trial would be possible, this study looked 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.



What difference did this study make?

The PROUD study showed that pre-exposure prophylaxis reduced the risk of infection by 86%. A total of 544 people from 13 sexual health clinics in England took part in the study. They were men who have sex with men, who reported having had anal sex without a condom in the previous three months. Only three men in the immediate PrEP group were infected with HIV, compared to 20 in the group who did not receive PrEP immediately. The three men who were infected in the immediate PrEP group were unlikely to have actually been taking PrEP when they were infected – one was probably infected before he started PrEP, and the other two had not collected their prescription of PrEP for several months before being diagnosed. There was no difference in the number of men diagnosed with other STIs between those on PrEP and those not on PrEP.

The videos above summarise the findings of the PROUD study, and the impact that it has had on participants.

These results have helped to change international guidelines on HIV prevention. They have been taken forward in the UK by the PrEP IMPACT study, which is looking at how many people attending sexual health clinics need PrEP, how many will start PrEP, and how long they need PrEP for.

Type of study

Randomised trial

Contact details

Who funded the study?

The pilot was 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 did it take place?

The study ran from November 2012 to October 2016.

Where did it take place?

PROUD took place at 13 Clinics:

• Birmingham (Heartlands)
• Brighton & Sussex University Hospital Trust
• 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 was included?

People who were born to male gender, aged 18 years or more, reporting unprotected anal intercourse, able to take Truvada and not needing treatment for Hepatitis B.