An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis.
Open accessAbstract
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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN94465371 . Date of registration: 28 February 2013.
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Studies have demonstrated that a daily oral medication TDF/FTC is effective in preventing HIV acquisition, and specifically among MSM.
“Studies have demonstrated that a daily oral medication TDF/FTC is effective in preventing HIV acquisition, and specifically among MSM (74,75,201).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [201]
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- Authors
- On behalf of the PROUD Study Group, Dolling, D. I., Desai, M., McOwan, A., Gilson, R., Clarke, A., Fisher, M., Schembri, G., Sullivan, A. K., Mackie, N., Reeves, I., Portman, M., Saunders, J., Fox, J., Bayley, J., Brady, M., Bowman, C., Lacey, C. J., Taylor, S., White, D., Antonucci, S., Gafos, M., McCormack, S., Gill, O. N., Dunn, D. T., & Nardone, A.
- Affiliations
- MRC Clinical Trials Unit at UCL (GB)
- Chelsea and Westminster Hospital NHS Foundation Trust (GB)
- Central and North West London NHS Foundation Trust (GB)
- Royal Sussex County Hospital (GB)
- St Mary's Hospital (GB)
- Barts Health NHS Trust (GB)
- Guy's and St Thomas' NHS Foundation Trust (GB)
- King's College Hospital NHS Foundation Trust (GB)
- Sheffield Teaching Hospitals NHS Foundation Trust (GB)
- Heart of England NHS Foundation Trust (GB)
- Public Health England (GB)
- Corresponding author
- McCormack, Sheena
- ORCID
- Venue
- Trials
- Published
- 2016-03-24
- Volume
- 17
- Issue
- 1
- Pages
- 163-163
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4806447
- OpenAlex
- W2303615074
- Cited by
- 51
- References
- 31
- Citations by year
- 2026: 3 · 2024: 3 · 2023: 3 · 2022: 4 · 2021: 5 · 2020: 10 · 2019: 6 · 2018: 8 · 2017: 9
- FWCI
- 7.08
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion, other-oa)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Gilead Sciences
- King's College Hospital NHS Foundation Trust
- Heart of England NHS Foundation Trust
- National Institute for Health and Care Research (ACF-2008-20-002)
- King's College London
- University College London
- Public Health England
- Sheffield Teaching Hospitals NHS Foundation Trust
- Barts Health NHS Trust
- Medical Research Council
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Keywords
- pre-exposure prophylaxis, tenofovir/emtricitabine, HIV prevention, men who have sex with men, sexual health clinic attendees, sexually transmitted infections, sexual behavior, unprotected sex, HIV incidence, baseline characteristics, real-world effectiveness, post-exposure prophylaxis
- MeSH terms
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Adolescent, Adult, Drug Administration Schedule, England, Humans, Male, Middle Aged, Pilot Projects, Primary Prevention, Surveys and Questionnaires, Risk Factors, Socioeconomic Factors, Time Factors, HIV Infections, Incidence, Treatment Outcome, Homosexuality, Male, Risk Assessment, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Unsafe Sex, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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