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High Adherence to HIV Pre-exposure Prophylaxis and No HIV Seroconversions Despite High Levels of Risk Behaviour and STIs: The Australian Demonstration Study PrELUDE

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Abstract

PrELUDE study evaluated daily pre-exposure prophylaxis (PrEP) in high-risk individuals in Australia. This open-label, single-arm study tested participants for HIV/STI and collected behavioural information three-monthly. We report trends over 18 months in medication adherence, side-effects, HIV/STI incidence and behaviour. 320 gay/bisexual men (GBM), 4 women and 3 transgender participants, followed on average 461 days, reported taking seven pills/week on 1,591 (88.5%) occasions and 4-6 pills/week on 153 (8.5%) occasions. No HIV infections were observed. STI incidence was high and stable, while gonorrhoea infections declined from 100.0 to 25.8/100 person-years between 6 and 15 months (p < 0.001). The number of HIV-positive and unknown-status sex partners, and condomless anal intercourse, significantly increased. In this high-risk cohort of mainly GBM, increases in risk behaviours and high STI incidence were not accompanied by HIV infections due to high adherence to daily PrEP. The study informed policy and further PrEP implementation among Australian GBM.

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Acknowledgements

PRELUDE Study Team: Mark Bloch, Andrew Carr, Ching (Yvonne) Cheung (study clinical coordinator), Rosalind Foster, Chris Gianacas (clinical data manager), Andrew Grulich, Rebecca Guy, Martin Holt, John Kaldor, Brent Mackie, Kenneth Mayer, John McAllister, Anna McNulty, Dean Murphy, Catriona Ooi, Catherine Pell, Isobel Mary Poynten, Garrett Prestage, Nathan Ryder, David Templeton, Stefanie Vaccher (behavioural data manager), John de Wit, Edwina Wright, and Iryna Zablotska (chief investigator and protocol chair). Participating clinics: Clinic 16 at Royal North Shore Hospital, Holdsworth House Medical Practice, Newcastle Sexual Health Service, RPA Sexual Health, St Vincent’s Hospital HIV Immunology and Infectious Diseases Unit, Sydney Sexual Health Centre, Taylor Square Private Clinic, and Western Sydney Sexual Health Centre. Community partner organisations: ACON (formerly AIDS Council of NSW) and Positive Life NSW.

Funding

The study was funded by the NSW Ministry of Health. Gilead Sciences provided the study medication, Truvada®. The views expressed in this publication do not necessarily represent the position of these organisations.

Author information

Authors and Affiliations

  1. The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia

    Iryna B. Zablotska, Stefanie J. Vaccher, Rosalind Foster, Andrew E. Grulich, Rebecca Guy, Isobel M. Poynten, Garrett Prestage & David Templeton

  2. Sydney Medical School - Westmead, Western Sydney Sexual Health Centre, University of Sydney, Level 4, Jeffery House, 162 Marsden Street, Parramatta, NSW, 2150, Australia

    Iryna B. Zablotska

  3. Holdsworth House Medical Practice, Sydney, NSW, Australia

    Mark Bloch

  4. St. Vincent’s Hospital, Sydney, NSW, Australia

    Andrew Carr

  5. Clinic 16 Northern Sydney Sexual Health, Royal North Shore Community Health Centre, St Leonards, NSW, Australia

    Rosalind Foster

  6. Sydney Sexual Health Centre, Sydney, NSW, Australia

    Anna McNulty

  7. Western Sydney Sexual Health Centre, Western Sydney Local Health District, Parramatta, NSW, Australia

    Catriona Ooi

  8. Centre for Infectious Diseases and Microbiology, Westmead Clinical School, University of Sydney, Sydney, NSW, Australia

    Catriona Ooi

  9. Taylor Square Private Practice, Sydney, NSW, Australia

    Catherine Pell

  10. Pacific Clinic, Newcastle, NSW, Australia

    Nathan Ryder

  11. RPA Sexual Health, Sydney Local Health District and Central Clinical School, The University of Sydney, Sydney, NSW, Australia

    David Templeton

Authors
  1. Iryna B. Zablotska
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  2. Stefanie J. Vaccher
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  3. Mark Bloch
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  4. Andrew Carr
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  5. Rosalind Foster
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  6. Andrew E. Grulich
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  7. Rebecca Guy
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  8. Anna McNulty
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  9. Catriona Ooi
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  10. Catherine Pell
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  11. Isobel M. Poynten
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  12. Garrett Prestage
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  13. Nathan Ryder
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  14. David Templeton
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Consortia

the PrELUDE Study Group

  • Mark Bloch
  • , Andrew Carr
  • , Ching Cheung
  • , Rosalind Foster
  • , Chris Gianacas
  • , Andrew Grulich
  • , Rebecca Guy
  • , Martin Holt
  • , John Kaldor
  • , Brent Mackie
  • , Kenneth Mayer
  • , John McAllister
  • , Anna McNulty
  • , Dean Murphy
  • , Catriona Ooi
  • , Catherine Pell
  • , Isobel Mary Poynten
  • , Garrett Prestage
  • , Nathan Ryder
  • , David Templeton
  • , Stefanie Vaccher
  • , John de Wit
  • , Edwina Wright
  •  & Iryna Zablotska

Contributions

IBZ, AEG, RG, IMP and GP were involved in the conception and design of the study. IBZ was the Protocol Chair. SJV, MB, AC, RF, AM, CO, CP, NR and DT oversaw participant recruitment and data collection. IBZ and SJV conducted the analysis. IBZ wrote the manuscript with input from all co-authors. All authors met the International Committee of Medical Journal Editors criteria for authorship, and read and approved the final manuscript.

Corresponding author

Correspondence to Iryna B. Zablotska.

Ethics declarations

Ethical Approval

The study protocol was reviewed and approved by the St Vincent’s Hospital Human Research Ethics Committee (HREC) in Sydney, NSW (Protocol #HEPP 1403; identification #HREC/14/SVH/130) and was registered at ClinicalTrials.gov (identifying #NCT02206555).

Additional information

A list of the PrELUDE study group is given in Acknowledgements section.

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Zablotska, I.B., Vaccher, S.J., Bloch, M. et al. High Adherence to HIV Pre-exposure Prophylaxis and No HIV Seroconversions Despite High Levels of Risk Behaviour and STIs: The Australian Demonstration Study PrELUDE. AIDS Behav 23, 1780–1789 (2019). https://doi.org/10.1007/s10461-018-2290-3

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  • DOI: https://doi.org/10.1007/s10461-018-2290-3

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