title: An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis.
abstract: BACKGROUND
  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.
  
  
  METHODS
  The 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).
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN94465371 . Date of registration: 28 February 2013.
authors.affiliation: MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: David I
authors.initials: DI
authors.lastname: Dolling
authors.affiliation: MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.|HIV/STI Department, Public Health England, London, UK.
authors.forename: Monica
authors.initials: M
authors.lastname: Desai
authors.affiliation: Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.
authors.forename: Alan
authors.initials: A
authors.lastname: McOwan
authors.affiliation: The Mortimer Market Centre, Central and Northwest London NHS Foundation Trust, London, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Gilson
authors.affiliation: Claude Nichol Centre, Royal Surrey Sussex County Hospital, Brighton, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Clarke
authors.affiliation: Claude Nichol Centre, Royal Surrey Sussex County Hospital, Brighton, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Fisher
authors.affiliation: Manchester Centre for Sexual Health, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Schembri
authors.affiliation: Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.
authors.forename: Ann K
authors.initials: AK
authors.lastname: Sullivan
authors.affiliation: St Mary's Hospital, Imperial College NHS Foundation Trust, London, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Mackie
authors.affiliation: Homerton University Hospital NHS Foundation Trust, London, UK.
authors.forename: Iain
authors.initials: I
authors.lastname: Reeves
authors.affiliation: Ambrose King Centre, Barts Health NHS Trust, London, UK.
authors.forename: Mags
authors.initials: M
authors.lastname: Portman
authors.affiliation: Ambrose King Centre, Barts Health NHS Trust, London, UK.
authors.forename: John
authors.initials: J
authors.lastname: Saunders
authors.affiliation: Guy's and St Thomas' NHS Foundation Trust, London, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Fox
authors.affiliation: King's College Hospital NHS Foundation Trust, London, UK.
authors.forename: Jake
authors.initials: J
authors.lastname: Bayley
authors.affiliation: King's College Hospital NHS Foundation Trust, London, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Brady
authors.affiliation: Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Bowman
authors.affiliation: York Hospitals NHS Foundation Trust, York, UK.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Lacey
authors.affiliation: Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Taylor
authors.affiliation: Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: David
authors.initials: D
authors.lastname: White
authors.affiliation: Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.
authors.forename: Simone
authors.initials: S
authors.lastname: Antonucci
authors.affiliation: MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: Mitzy
authors.initials: M
authors.lastname: Gafos
authors.affiliation: MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK. s.mccormack@ucl.ac.uk.
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.affiliation: HIV/STI Department, Public Health England, London, UK.
authors.forename: Owen N
authors.initials: ON
authors.lastname: Gill
authors.affiliation: MRC Clinical Trials Unit at UCL, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.
authors.forename: David T
authors.initials: DT
authors.lastname: Dunn
authors.affiliation: HIV/STI Department, Public Health England, London, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Nardone
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects; D004739:England / Q000453:epidemiology; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D018451:Homosexuality, Male; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011322:Primary Prevention / Q000379:methods*; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D012307:Risk Factors; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D047568:Unsafe Sex / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D018894:Reverse Transcriptase Inhibitors
keywords: HIV prevention; Men who have sex with men (MSM); Pre-exposure prophylaxis (PrEP); Tenofovir; Truvada