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NZPrEP Demonstration Project: protocol for an open-label, single-arm trial of HIV pre-exposure prophylaxis (PrEP) to determine feasibility, acceptability, adverse and behavioural effects of PrEP provision to gay and bisexual men in publicly funded sexual health clinics in Auckland, New Zealand
  1. Sunita Azariah1,
  2. Peter Saxton2,
  3. Richard Franklin3,
  4. Rose Forster1,
  5. Suzanne Werder1,
  6. Renee Jenkins1
  1. 1 Auckland Regional Sexual Health Service, Auckland District Health Board, Auckland, New Zealand
  2. 2 School of Population Health, University of Auckland, Auckland, New Zealand
  3. 3 Self-Employed, Sydney, New South Wales, Australia
  1. Correspondence to Dr Sunita Azariah; SunitaA{at}adhb.govt.nz

Abstract

Introduction New Zealand has experienced a rise in HIV diagnoses in recent years and new interventions are required to address this.

Methods and analysis NZPrEP (A demonstration project of HIV preexposure prophylaxis in Aotearoa New Zealand) is an open-label, single-arm treatment evaluation study to investigate feasibility, retention, adherence, and clinical and behavioural outcomes of HIV pre-exposure prophylaxis (PrEP) provision to gay and bisexual men (GBM) in a publicly funded secondary sexual health service in Auckland, New Zealand. The sample size is 150 GBM. Inclusion criteria were specific behavioural risk factors indicating an increased risk of HIV infection. Exclusion criteria were hepatitis B infection, any medical contraindications to prescribing tenofovir/emtricitabine or factors limiting ability to adhere to the study protocol. Eligible participants will be screened for HIV and other sexually transmissible infections (STIs) and for any medical contraindications to PrEP, and enrolled for a maximum follow-up period of 96 weeks. They will be required to attend for 3-monthly testing for HIV and STIs and monitoring for renal and liver toxicity. Participants will also be required to complete an online behavioural survey after each study visit. The outcomes of interest are feasibility of PrEP provision in a sexual health clinic setting, PrEP acceptability, and adverse medical and behavioural effects of PrEP. The study sample is limited to 150 participants due to funding and service constraints. Statistical analysis of all primary and secondary outcomes will be performed using Stata V.14 at the University of Auckland. Results for primary and secondary endpoints will be reported after the conclusion of the study in March 2019.

Ethics and dissemination The study was approved by the Health and Disability Ethics Committee on 15 September 2016 (16/NTA/112). Key findings will be submitted to peer-reviewed journals. A summary report will be circulated to the study and community stakeholders, and to the Auckland District Health Board, Ministry of Health and Pharmac.

Trial registration number ACTRN12616001387415; Pre-results.

  • HIV
  • pre-exposure prophylaxis
  • clinical trial
  • observational study
  • clinical protocol

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Footnotes

  • Contributors SA did the ethics application for the study. SA, RFr, RFo, SW and PS designed the protocol for the study. PS designed the behavioural survey and is responsible for data analysis for the survey. RAF secured funding for the study from Gilead Sciences. SW provides liaison with the community pharmacies and Gilead for medication supplies. RJ (research nurse) will enrol participants, manage follow-up and communication with participants, and will manage the clinical database. SA and PS wrote the initial draft for the paper, and all authors critically reviewed and approved the final draft submitted for publication.

  • Funding This work is supported by Gilead Sciences, which will provide the study medication and funding for a research nurse and some of the study-associated laboratory costs. The Auckland District Health Board is funding the clinician time, clinic visits and the laboratory costs associated with the STI testing and serology for HIV, syphilis and hepatitis. NZAF and BP are providing support through dedicated staff time and resources. Funding for the online behavioural survey is being provided independently by a grant from the New Zealand AIDS Foundation and by Pharmac. None of the funding bodies will be involved in data analysis or dissemination of the study results.

  • Competing interests None declared.

  • Ethics approval The study has received ethics approval from the Health and Disability Ethics Committee (HDEC) 16/NTA/112 on 15 September 2016.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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