Update on trial timelines

In April 2014, we announced that we had applied for additional funding to expand the PROUD pilot study into a full trial and if successful, hoped to reopen for recruitment early in 2015. A number of volunteers have already added their names to clinic registers of people interested in PrEP so they can be informed if recruitment reopens.

In October 2014, an interim analysis of the PROUD pilot study data showed that pre-exposure prophylaxis (PrEP) is highly protective against HIV in the PROUD pilot study population. As a result, we changed the study design and offered all enrolled participants the opportunity to access PrEP.

Due to this exciting result, we need to change the design of the planned full trial, as it is no longer acceptable to include a year when participants have no PrEP. This means that we need to resubmit the application. The funders have indicated that they will speed up the review process, but there will still be a delay of several months. If we are successful, the earliest study recruitment could reopen would be 2016.

Volunteers are still welcome to register their interest in participating in future studies directly with PROUD clinics or via the PROUD email address (mrcctu.trial-proud@ucl.ac.uk) and we will aim to keep you up to date on the progress of the funding application via the PROUD website (http://www.proud.mrc.ac.uk/).

While the delay to the full trial is unfortunate, the early finding from the PROUD pilot study will help the Clinical Reference PrEP working group develop a policy on the use of PrEP in the UK.