NZ PrEP
Sunita Azariah
Auckland Regional Sexual Health
Service
How it started
A group of us got together in 2015 and had a
discussion about how we could implement our
own demonstration project in NZ
Currently a collaboration between ARSHS,NZAF,
Body Positive and the University of Auckland-
project is supported by Infectious Diseases
Service in Auckland
Slow start as main stumbling block was getting
funding and approval from ADHB –also most of us
are not researchers by trade(except Peter Saxton)
Researchers
Clinical-Sunita Azariah, Suzanne Werder, Rick
Franklin, Rose Forster
Behavioural and qualitative surveys-Peter
Saxton
PrEP Website and research database-Mark
Fisher
Community Engagement –NZAF-Jordon
Harris(Kaiarahi),Nick Laing
Process
Looked at various protocols from overseas-mainly
Australian
Ours is mainly based on Prelude
Developed draft protocol and participation
information sheets, consent forms
Discussion with ARSHS management as to
whether they would support this-cautious
endorsement but advised prescribing generic
tenofovir/emtricitabine would not be an option
within ADHB as no NZ licensed product available
Rationale
HIV is a serious public health issue
Numbers of new HIV infections are increasing
Other STIs such as syphilis are on the rise
predominantly in GBM
Approximately 6.5% of GBM in Auckland are HIV
positive-over half of new infections are reported
in Auckland
ARSHS is ideally positioned for this project as
sexual health clinics are preferred site of HIV
testing for GBM
PrEP
PrEP or pre-exposure prophylaxis involves taking
tenofovir/emtricitabine usually on a daily basis to
prevent HIV acquisition
If taken correctly it prevents 80 to 90% of incident
infections compared with controls
Harms so far appear to be minimal however there
is evidence of increased high-risk behaviour and
increased incidence of other STIs in some GBM in
later analyses of overseas demonstration projects
Aims
To assess the implementation of a novel
intervention-namely PrEP in a sexual health
clinic setting to individuals at high risk of HIV
acquisition
Reduce incident infections
Assess feasibility of introducing this intervention
Refine clinical protocols to optimise service
delivery
Objectives
Assess acceptability of PrEP -adherence; duration;
retention;
Assess risk behaviours on PrEP including sexual
partnering; condom use; STI and HIV incidence
Analysis of factors (socio-demographic and
attitudes) associated with PrEP acceptability,
retention and behaviours
The lived experience of PrEP use including
disclosure; stigma; sexual negotiation.
Process (2)
Draft budget drawn up
ARSHS management expressed concerns re service capacity-agreed
that 150 participants would be feasible within current service
volumes and constraints
Application made to ADHB Trust fund in May 2015-rejected-
”Service delivery, not research”
Gilead kindly agreed to fund medications and research associated
costs-Truvada plus 150K(facilitated by Rick Franklin)
ADHB is funding costs associated with usual patient care including
clinic visits, STI and HIV testing, clinician time
NZAF has generously agreed to up to 30k of additional funding as
required-so far not tagged to any specific component
Independent source of funding to be sought for behavioural
component-HRC application (Peter Saxton)
Protocol
Open-label single-arm treatment evaluation study
-150 participants
GBM at elevated risk of HIV will be recruited via:
routine clinic visits to ARSHS, websites, targeted
promotion, community partnerships
Study will be powered to detect ethnic
differences in adherence and retention-if 20% of
participants are Maori, we have 72% power to
detect suboptimal study retention compared to
non-Maori
Duration 24 months
Participant visit schedule
Attend Sexual Health Service for routine appointment
STI screen, including test for HIV
Discuss PrEP study; information to take away
Visit 1
Appointment with research nurse for results, treatment of any STIs, consent
forms, discussion, prescription for PrEP
Visit 2
Sexual health check and general review
STI screen including blood test for HIV, urine and swabs
Check for adverse effects of medication
Telephone consult
Phone review by research nurse: adherence, symptoms, side effects,
opportunity for questions
Visit 3
Sexual health check and general review
STI screen including blood test for HIV, urine and swabs
Check for adverse effects of medication
Visit 4 onwards
Sexual health check and general review
STI screen including blood test for HIV, urine and swabs
Check for adverse effects of medication
Week 1
Week 2
Week 4
Week 12
Every 3 months until end
of study (12-24 months)
Peer educator for risk reduction counselling
Online behavioural survey within 3 days of appointment
Online behavioural survey within 3 days of appointment
Online behavioural survey within 3 days of appointment
Online behavioural survey within 3 days of appointment
Week 0
Call 0800 739432 to make an appointment in response to PrEP advertising,
or for a routine check-up
Where we are at currently
Ethics approval from Northern health and Disability
ethics committee obtained
ARSHS management sign-off completed
Waiting ADHB research office approval sign-off-budget
has been approved(Suzanne W facilitating)
Waiting to see if HRC application has been approved
for on-line behavioural survey and qualitative
research(Peter S)
Clinical protocols etc. are being drafted (Rose F)
Development of Research database in process(Mark F)
Staff training sessions booked in for later this year