An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis.

David Dolling ,Sheena Mccormack,Iain Reeves,Stephen Taylor,Amanda Clarke,David White,John Saunders,Simone Antonucci,Jake Bayley,Julie Fox,Gabriel Schembri,Anthony Nardone,Mitzy Gafos,Monica Desai,Michael Brady,Christine Bowman,Nicola Mackie,Alan Mcowan,Mags Portman,Richard Gilson,Fabiola Martin ,David Dunn ,Charles Lacey ,O N Gill ,Ann Sullivan

doi:10.1186/s13063-016-1286-4

Abstract

BackgroundPre-exposure prophylaxis (PrEP) has proven biological efficacy to reduce the sexual acquisition of the human immunodeficiency virus (HIV). The PROUD study found that PrEP conferred higher protection than in placebo-controlled trials, reducing HIV incidence by 86 % in a population with seven-fold higher HIV incidence than expected. We present the baseline characteristics of the PROUD study population and place the findings in the context of national sexual health clinic data.MethodsThe PROUD study was designed to explore the real-world effectiveness of PrEP (tenofovir-emtricitabine) by randomising HIV-negative gay and other men who have sex with men (GMSM) to receive open-label PrEP immediately or after a deferral period of 12 months. At enrolment, participants self-completed two baseline questionnaires collecting information on demographics, sexual behaviour and lifestyle in the last 30 and 90 days. These data were compared to data from HIV-negative GMSM attending sexual health clinics in 2013, collated by Public Health England using the genitourinary medicine clinic activity database (GUMCAD).ResultsThe median age of participants was 35 (IQR: 29–43). Typically participants were white (81 %), educated at a university level (61 %) and in full-time employment (72 %). Of all participants, 217 (40 %) were born outside the UK. A sexually transmitted infection (STI) was reported to have been diagnosed in the previous 12 months in 330/515 (64 %) and 473/544 (87 %) participants reported ever having being diagnosed with an STI. At enrolment, 47/280 (17 %) participants were diagnosed with an STI. Participants reported a median (IQR) of 10 (5–20) partners in the last 90 days, a median (IQR) of 2 (1–5) were condomless sex acts where the participant was receptive and 2 (1–6) were condomless where the participant was insertive. Post-exposure prophylaxis had been prescribed to 184 (34 %) participants in the past 12 months. The number of STI diagnoses was high compared to those reported in GUMCAD attendees.ConclusionsThe PROUD study population are at substantially higher risk of acquiring HIV infection sexually than the overall population of GMSM attending sexual health clinics in England. These findings contribute to explaining the extraordinary HIV incidence rate during follow-up and demonstrate that, despite broad eligibility criteria, the population interested in PrEP was highly selective.Trial registrationCurrent Controlled TrialsISRCTN94465371. Date of registration: 28 February 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1286-4) contains supplementary material, which is available to authorized users.

Highlights

Pre-exposure prophylaxis (PrEP) has proven biological efficacy to reduce the sexual acquisition of the human immunodeficiency virus (HIV)
Recruitment The PROUD pilot study enrolled the first participant on 27 November 2012
The pilot study was initially expected to fully recruit within 6 months, but this target was modified in April 2013 due to slow recruitment, attributed to lack of study resources delaying clinic activation, and low awareness of PrEP in the community [19]

Summary

Introduction

Pre-exposure prophylaxis (PrEP) has proven biological efficacy to reduce the sexual acquisition of the human immunodeficiency virus (HIV). The PROUD study found that PrEP conferred higher protection than in placebo-controlled trials, reducing HIV incidence by 86 % in a population with seven-fold higher HIV incidence than expected. We present the baseline characteristics of the PROUD study population and place the findings in the context of national sexual health clinic data. In England, gay and other men who have sex with men (GMSM) are the population most likely to acquire HIV sexually, according to surveillance data routinely collected from sexual health clinics. Using the CD4 back calculation estimate of HIV incidence, 2470 men who have sex with men (MSM) were estimated to have acquired their HIV infection in the UK in 2013. Modelling suggests that introducing PrEP would have a large impact on the UK epidemic [6], in the context of provision to an appropriate population [7]

Methods

Results

Conclusion