PROUD v 1.0

• Research type

  Research Study

• Full title

  PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men

• IRAS ID

  107457

• Contact name

  Sheena McCormack

• Sponsor organisation

  Medical Research Council

• Eudract number

  2012-002373-56

• Research summary

  The aim of this study is to assess what happens when a new approach, known as PrEP, is added to the existing methods available to gay men in the UK to reduce their risk of catching HIV infection. PrEP is short for pre-exposure prophylaxis. Prophylaxis is taking a drug to prevent, or at least reduce the risk of, catching an infection. In this study we will use a drug called Truvada, which is commonly used to treat HIV. It is a combination of tenofovir and emtricitabine in a single pill, to be taken once a day. A major concern about HIV negative individuals taking PrEP, is that they will decrease their use of other methods such as condoms, thereby increasing their risk of HIV and other sexually transmitted infections. This can only be assessed when people know they are taking an active drug. This study will therefore offer people PrEP on an ??open label?? basis, meaning that everyone who takes it will know they are taking the drug; no-one will take an inactive placebo pill. In order to assess what happens when PrEP is added, we will need to follow one group for a period before the PrEP is included, at a time when they are accessing the best available methods for reducing risk. To do this, half of the volunteers will be offered PrEP immediately, and the other half after 12 months. All participants will be offered other interventions to reduce their risk. They will be followed in clinic every 3 months for 2 years, and tested for HIV. A screen for sexually transmitted infections will be done every 6 months or more frequently if indicated. In between visits, participants will be asked to complete a diary and monthly questionnaire reporting anal intercourse and their pill taking when they are on Truvada.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1289

• Date of REC Opinion

  2 Oct 2012

• REC opinion

  Further Information Favourable Opinion