PROUD Study Summary

The two-year study will recruit volunteers across England, who will be placed at random into one of two groups. One group will use PrEP from the start of the study, and the other group will receive PrEP after 12 months. Both groups will receive support to remain HIV negative throughout the study.

Participants are asked to keep a short daily diary, fill out a monthly questionnaire and attend a clinic appointment every three months.

This study is looking at a new way to reduce the risk of getting HIV. It will look at the impact of taking PrEP on how often men have sex; how often they use condoms; and whether they get other sexually transmitted infections.

In October 2014 an interim analysis of the PROUD study data showed that pre-exposure prophylaxis (PrEP) was highly protective against HIV for gay men and other men who have sex with men (MSM) at high risk of infection. The PROUD Trial Steering Committee announced that participants on the deferred arm of the study, who had not yet started PrEP, should be offered the opportunity to begin PrEP ahead of schedule. As a result, we changed the study design and offered all enrolled participants the opportunity to access PrEP. All study participants will be followed up until study closure in April 2016