Pre-exposure Option for Reducing HIV in the UK.(PROUD) — PROUD  

HIV Clinical Trial

Official 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.(PROUD)

Status Completed

Clinical Trial Summary

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! 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 October 2016

Clinical Trial Description

Intervention and control groups:

Arm A: Immediate offer of Truvada-PrEP Arm B: Deferred (12m) offer of Truvada-PrEP

Method of randomisation:

Randomisation will be performed centrally using a computer algorithm based on random permuted blocks stratified by site. ;

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

• NCT number: NCT02065986
• Study type: Interventional
• Source: Medical Research Council
• Status: Completed
• Phase: Phase 4
• Start date: October 2012
• Completion date: October 2016