Transcript the presentation - IUSTI Marrakesh 2016 :: Home

PrEP
implentation in
NSW, Australia
C. Assoc Prof Anna McNulty
Director, Sydney Sexual Health Centre
May 2016
Background
 This is the Main Body Slide.
 This slide is based on the
Population NSW: 7.6
million
Background
•
Estimated that in 2006 there were 76,000 gay and bisexual
men (GBM) in NSW
•
11% HIV positive
•
80% of HIV notifications are GBM
•
A peak in HIV notifications in 2012 led to NSW Ministry of
Health ‘Ending HIV’ strategy
Background
•
90% of GBM with HIV in NSW are diagnosed
•
•
Further increases in testing are possible (communitybased testing; home-based testing)
80-90% of GBM are on treatment
•
Post START, this will increase even further
•
Move towards immediate/rapid treatment at diagnosis
• About 30% of HIV negative gay men with casual
sexual partners report condomless anal intercourse
in the last 6 months.
NSW PrEP guidelines
Men who are likely to report multiple events of CLAI in
the next 3 months (sustained risk) and any of the
following
• At least one episode of receptive CLAI with unknown status or
HIV positive casual partners
• Have a regular sex partner who is HIV positive, condoms not
consistently used, and detectable viral load
• Rectal STI (gono/CT) or syphilis
• Methamphetamine use in last 3 months
How many high-risk gay men in NSW?
Potential impact of PrEP
•
Estimated about 3700 high risk gay men are eligible for PrEP
under current guidelines
•
Estimated HIV incidence of 4 infections / 100 person years
•
If PrEP is 86% effective, about 150 HIV infections in this
group can be prevented per year among study participants
•
•
Represents about a 50% reduction in HIV transmission
•
Many more secondary infections prevented
Both rapid and large-scale roll out is needed for this rapid and
large-scale reduction in new HIV diagnoses
Study proposal: EPIC – NSW
Expanded PrEP Implementation in Communities in
NSW
• Project involves Kirby Institute, UNSW ( PI Prof David
Cooper), NSW Ministry of Health, community organisations,
public and private medical practitioners
• An implementation research project measuring population
health outcomes
•
25 or more clinics
•
public and private sites
•
enrolled over 12 month period
•
7400 person years on drug
•
will need to recruit 300-400 new men on PrEP per month after study
start
Eligibility criteria
•
High risk GBM ( according to NSW PrEP guidelines)
Transgender also included
•
Heterosexual men and women
– being likely to have multiple events of unprotected vaginal or anal
intercourse (UVI or UAI, respectively), with or without sharing IDU,
in the next 3 months (indicating sustained risk)
– AND
– being a regular sexual partner of an HIV-infected man or woman
with whom condoms were not consistently used in the last 3
months (HIV positive partner is not on treatment and/or has
detectable viral load);
• Simplicity of trial procedures
•
Simplified consent and enrolment procedures
•
electronic capture of outcome data
•
behavioural and adherence studies optional, managed through webbased capture by the Kirby Institute
•
no requirement for any CRFs to be completed by clinic nurses
•
no requirement for completeness of follow-up beyond normal clinic
procedures (eg SMS reminders)
Primary endpoints
 Incidence of HIV per 100 py among participants.
 HIV diagnoses among GBM notified to the NSW Ministry of
Health.
Secondary endpoints
 Incidence of STI per 100 py among participants
 Rate of enrolment to the study by clinic type
 Patterns of daily PrEP use and adherence to the medication
schedule among study participants
 Monitor behavioural risk practices among PrEP users in the
study cohort
Marketing
 soft launch using
existing waitlists to avoid
overloading limited open
sites
 PREP infoline to triage
and screen for eligibility
 Ministerial launch end
May ~ 1000 recruited
Progress to date
•
Recruitment commenced March 1
•
Currently 7 sites open (3 private, 4 public)
•
Generic TDF/ FTC sourced and contract signed
0
200
400
600
Cumulative Enrollments
800
1000
Enrolment to date (3rd May)
0
2
4
Week
6
8
10
Challenges
•
Short turnaround ( 3 months ) from announcement to first
enrolment
•
Minimal additional funding for public sector clinics
•
Ability to absorb additional work on top of existing workload
•
Asymptomatic patients being seen by doctors ( need to
prescribe )
•
Drug supply
Acknowledgements
•
Kirby Institute, UNSW ( Prof Andrew Grulich, Iryna
Zablotska)
•
ACON
•
NSW Ministry of Health
•
Clinicians and participants