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

IntroductionNew Zealand has experienced a rise in HIV diagnoses in recent years and new interventions are required to address this.Methods and analysisNZPrEP (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 disseminationThe 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 numberACTRN12616001387415; Pre-results.

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Baseline characteristics of gay and bisexual men in a HIV pre-exposure prophylaxis demonstration project with equity quotas in Auckland, New Zealand

Sexual Health ◽

10.1071/sh18056 ◽

2019 ◽

Vol 16 (1) ◽

pp. 47 ◽

Cited By ~ 2

Author(s):

Peter J. W. Saxton ◽

Sunita Azariah ◽

Richard A. Franklin ◽

Rose F. Forster ◽

Suzanne F. Werder ◽

...

Keyword(s):

New Zealand ◽

Risk Behaviour ◽

Gay And Bisexual Men ◽

Demonstration Project ◽

Receptive Anal Intercourse ◽

Sexual Risk Behaviour ◽

Bisexual Men ◽

Baseline Characteristics ◽

And Bisexual ◽

Exposure Prophylaxis

Background In New Zealand, pre-exposure prophylaxis (PrEP) should target gay and bisexual men (GBM), and equity is an important principle. Baseline characteristics of GBM offered PrEP in a demonstration project with an enrolment quota of 50% non-Europeans are described. Methods: An open-label, single-arm treatment evaluation study design (‘NZPrEP’) was used. The settings were four publicly funded sexual health clinics in Auckland in 2017. The study population was 150 GBM recruited from clinics, community sources and social media. Participants self-completed an online questionnaire about PrEP awareness, attitudes and sexual risk behaviour in the last 3 months. Baseline characteristics are described and examined to determine whether these were associated with PrEP initiation status (self-referral vs doctor/nurse recommendation). Results: In total, 150 GBM of whom half (52%) were non-European, including 21.3% Maori, 19.3% Asian and 8.7% Pacific, were enrolled into the study. Two-thirds (65.3%) self-referred for PrEP and one-third (34.7%) were recommended PrEP by the doctor/nurse. Participants reported a high number of male condomless receptive anal intercourse partners (MenAICLR) (median 3, range 0–50), with 10% reporting 10 or more MenAICLR and 45.3% reporting group sex. In the previous year, 65.3% had a sexually transmissible infection (STI); 18% had rectal chlamydia or gonorrhoea at enrolment. Almost half (47.7%) had recently used drugs with sex, including 8.1% who used methamphetamine. Participants recommended PrEP had lower education, lived less centrally and had a higher STI prevalence than PrEP self-referrers, but their risk behaviour was similar. Conclusions: Early PrEP adopters in New Zealand have high HIV risk. Demonstration projects should consider equity mechanisms so that minorities can participate meaningfully.

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