PROUD UK PrEP study completes enrollment – first data gives participants' background and risk factors

Published: April 9, 2014

The pilot stage of the PROUD study – the UK’s study of HIV pre-exposure prophylaxis (taking HIV drugs to prevent HIV) in gay men – is now fully enrolled, the trial’s Community Engagement Group announced yesterday. As of Wednesday 9 April, the trial reached its target of 550 participants.

The trial investigators have applied for funding to expand PROUD into a full-scale efficacy trial with 2300 participants. A final decision on this is expected in November, meaning that any expansion will not start recruiting till spring next year. 
This means that, in England, PrEP will not be available other than by private prescription to anyone else till then. Resources are currently being sought so that current participants do not have to start coming off PrEP in November this year unless they wish to and can continue receiving it until the full study opens, if it does.    
The PROUD study
Last week’s British HIV Association (BHIVA) conference heard the first data from the study, namely the baseline data on the demographic makeup and risk behaviour of the participants. These data from PROUD were presented by investigator Dr Monica Desai of Public Health England. 
PROUD (which stands for PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men) started enrolling in November 2012, after the US Food and Drug Administration licensed Truvada (tenofovir/emtricitabine) once-daily as PrEP in the USA in July 2012.
PROUD is a two-year study with participants randomised either to take Truvada daily for two years or to take it only during the second year. Full results from the pilot study will therefore not be available till Summer 2016, unless the statisticians monitoring the trial detect a result that is so strongly positive or negative it can be stopped early.
Unlike the iPrEx study, which established the efficacy of PrEP in gay men, PROUD is open-label, meaning that no one gets a placebo. As well as potentially being able to measure the efficacy of PrEP in a much more ‘real world’ setting than that of a placebo-controlled trial (due to its small size, the PROUD pilot is not designed to provide a definitive answer on efficacy), the advantage of the open-label deferred-versus-immediate study is that, because all those taking PrEP know they are on active drug, the trial can take a true measurement of whether people change their sexual risk behaviour once they know they are taking PrEP.
Who joined and their HIV risk
The average age of the 443 participants with data was 35.5 years; a quarter was aged 29 or below and another quarter 42 or above. Eighty per cent of participants were white: 4% (14 individuals) black, 6% (27) south Asian and 10% (48) of other ethnic background. Nearly 60% were graduates and three-quarters had UK education to 18 (of the remainder, some had overseas qualifications): only 3% of participants were early school leavers.
It was possible for HIV-negative seroconcordant partners to enrol in PROUD together and be randomised to the same arm: there were 17 co-enrolled pairs in the study, and one triplet.
Participants reported a median of ten anal sex partners in the last three months. They reported having receptive anal sex without a condom with two partners and insertive anal sex without a condom with three, so at baseline they were using condoms with at least 50% and probably more of their partners.
Of participants’ partners, 23% were of unknown HIV status. Of the rest, 44% were known or assumed to be HIV negative. Of the one-third who were known to have HIV, 81% were known to be taking HIV treatment, 12% were known to be not on treatment (4% of all partners) and 7% were of unknown treatment status.
Participants were asked why they didn’t use condoms when they didn’t. Most gave several different reasons. The most common reason was “It’s much more enjoyable without a condom” (given by two-thirds of participants), “I don’t like using condoms” (half of them) or “My partner doesn’t like using condoms” (a third of them). Approximately a quarter each said that condoms weren’t discussed, that sex happened under the influence of drugs or alcohol, or that they didn’t consider that that particular sexual encounter risked HIV (e.g. it was with a long-term partner known to have recently tested negative). Seventeen per cent (74 individuals) said they had a ‘negotiated safety’ agreement with their partner whereby they used condoms with others but not their main partner.
No fewer than 40% of participants had used post-exposure prophylaxis (PEP) in the last 12 months before joining the study and 21% had used it more than once.
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