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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Medical Research Council
Sponsor:
Information provided by (Responsible Party):
MRC [ycm], Medical Research Council
ClinicalTrials.gov Identifier:
NCT02065986
First received: February 16, 2014
Last updated: February 18, 2014
Last verified: February 2014

February 16, 2014
February 18, 2014
October 2012
April 2016   (final data collection date for primary outcome measure)
Time to accrual of 500 participants and Retention at 12 and 24 months from randomisation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02065986 on ClinicalTrials.gov Archive Site
HIV infections acquired between trial entry and 12 months, and between 12 and 24 months [ Time Frame: 24months ]
Same as current
Not Provided
Not Provided
 
Pre-exposure Option for Reducing HIV in the UK.(PROUD)
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)

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!

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
  • Experimental: Arm A: Immediate offer of Truvada-PrEP
    Immediate offer of Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
    Intervention: Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
  • Arm B: Deferred (12m) offer of Truvada-PrEP
    Access to Truvada from 12 months after enrolment
    Intervention: Drug: Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
October 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Born to male gender, age 18 years or more
  • Previously attended the enrolling clinic on at least one occasion
  • Completed a screen for HIV and STIs
  • HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomisation
  • Reported unprotected anal intercourse (UAI) on more than one occasion within the 90 days prior to randomisation
  • Likely, in the opinion of the volunteer, to have UAI in the next 90 days
  • Willing and able to comply with the visit schedule throughout the follow-up period
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • An acute viral illness that could be due to HIV seroconversion
  • Any contraindications to Truvada according to the current package insert
  • Treatment for hepatitis B infection indicated or ongoing
  • Unlikely, in the opinion of the clinician, to comply with the randomised allocation
Male
18 Years and older
Yes
Contact: Prof Sheena McCormack +44 (0)20 7670-4708 s.mccormack@ucl.ac.uk
United Kingdom
 
NCT02065986
2012-002373-56
Yes
MRC [ycm], Medical Research Council
MRC [ycm]
Not Provided
Not Provided
Medical Research Council
February 2014

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