Protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) among people at high risk of HIV infection: the NSW Demonstration Project PRELUDE.
Despite a number of HIV prevention strategies, the number of new HIV infections remains high. In Australia, over three-quarters of new HIV diagnoses are in gay and bisexual men (GBM). Pre-exposure prophylaxis (PrEP) has been shown to be effective at preventing new HIV infections in several randomised trials. The PRELUDE study aims to evaluate the implementation of PrEP in healthcare settings in New South Wales (NSW), Australia, among a sample of high-risk adults.



PRELUDE is an ongoing open-label, single-arm demonstration project, conducted in public and private clinics across NSW, Australia. Enrolment began in November 2014. The study is designed for 300 high-risk participants-mainly GBM and heterosexual women. Participants receive daily oral PrEP, composed of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), for up to 2.5 years. Quarterly study visits include testing for HIV and sexually transmitted infections (STIs), assessment of ongoing eligibility and side effects, and self-reported adherence. Following each study visit, online behavioural surveys are administered to collect information on medication adherence, risk behaviours and attitudes. Blood samples will be collected in a subset of patients 1, 6 and 12 months after PrEP initiation to measure FTC/TDF concentrations. Analyses using longitudinal regression models will focus on feasibility, adherence, safety, tolerability and effects of PrEP on behaviour. This study will inform PrEP policy and guide the implementation of PrEP in Australia in people at high risk of HIV.



The study will be conducted in accordance with the Declaration of Helsinki. All patients will provide written informed consent prior to participation in the study. Publications relating to each of the primary end points will be gradually released after 12 months of follow-up is complete.



NCT02206555; Pre-results.
Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia.
S
S
Vaccher
Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia.
A
A
Grulich
St Vincent's Hospital, Darlinghurst, New South Wales, Australia.
J
J
McAllister
RPA Sexual Health, Sydney Local Health District, Camperdown, New South Wales, Australia.
D J
DJ
Templeton
Holdsworth House Medical Centre, Darlinghurst, New South Wales, Australia.
M
M
Bloch
Sydney Sexual Health Centre, Sydney, New South Wales, Australia.
A
A
McNulty
NSW Ministry of Health, North Sydney, New South Wales, Australia.
J
J
Holden
Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia.
I M
IM
Poynten
Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia Australian Research Centre in Sex, Health and Society, La Trobe University, Melbourne, Victoria, Australia.
G
G
Prestage
Kirby Institute, UNSW Australia, Kensington, New South Wales, Australia.
I
I
Zablotska
D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D000068679:Emtricitabine / Q000627:therapeutic use; D015658:HIV Infections / Q000517:prevention & control; D016304:Hospitals, Private; D055118:Medication Adherence; D009517:New South Wales; D065129:Pre-Exposure Prophylaxis / Q000379:methods; D015980:Public Health Practice; D012107:Research Design; D012309:Risk-Taking; D057566:Self Report; D000068698:Tenofovir / Q000627:therapeutic use; D013997:Time Factors; D017327:Clinical Trials, Phase IV as Topic; D015337:Multicenter Studies as Topic
D019380:Anti-HIV Agents; D000068679:Emtricitabine; D000068698:Tenofovir
Truvada; gay, homosexual, and other men who have sex with men; implementation research; pre-exposure prophylaxis