a randomised trial of point of care tests for chlamydia ... · communities 16‐19 yr olds ‐50%...
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A randomised trial of point‐of‐care tests for chlamydia and gonorrhoea infections in remote Aboriginal
communities(NHMRC project grant)
Investigators
o A/Professor Rebecca Guy, Mr James Ward, Professor John Kaldor, Professor Basil Donovan, A/Professor David Wilson, Dr Handan Wand, Dr David Regan, Dr Louise Causer, Steve Badman, Kirby Institute, UNSW
o Ms Belinda Hengel (QLD coordinator), Apunipima Health Councilo Ms Lisa Natoli (trial coordinator), A/Prof David Anderson, Burnet
Instituteo A/Prof Mark Shephard, Flinders Universityo A/Professor David Whiley, Queensland Paediatric Infectious
Diseases (QPID) Laboratoryo A/Professor Sepehr Tabrizi, Royal Women’s Hospitalo Professor Christopher Fairley, University of Melbourne/Melbourne
Sexual Health Centre
CollaboratorsWestern Australia: Ngaanyatjarra Health Service West Australia Department of
Health PathWest Aboriginal Health Council of
Western Australia Queensland: Queensland Aboriginal and
Islander Health Council Apunipima Cape York Health
Council Townsville Sexual Health service Queensland Health Queensland PathologySouth Australia: Aboriginal Health Council SA SA Health
Research Organisations: Kirby Institute, UNSW Baker IDI Apunipima Health Council Burnet Institute Royal Women’s Hospital, Melbourne QLD Paediatric Infectious Disease Laboratory Flinders University University of Melbourne
Funded through the National Health and Medical research Council
Why do we need a POC test for chlamydia and gonorrhoea?
CT and NG prevalence high in remote Aboriginal communities
16‐19 yr olds ‐ 50% prevalence of CT/NG/TV (STRIVE, 2010)Advances in testing and treatmentPCR testingSelf‐collected swabs and urineSingle dose antibiotics
Control of STIs compromised by delays in diagnosis and treatment
Considerable distances between health services and laboratories
Difficulties locating and recalling patients for treatment
Central AustraliaSmall communities100‐1000 people Large geographical areaSize of Thailand, SpainWeekly flights to labHighly mobile popn15‐20% untreated21 days to treatment (av)
TTANGO objectives
• Whether the addition of POC testing – Improves timeliness of
• Treatment• Partner notification
– Reduces infections• Re‐infections• Prevalence
– Acceptable?– Impacts on client flow?– Cost‐effective?
GeneXpert POC device
CepheidDisposable cartridge Infectious disease, oncology, genetic disease
Automate and host the PCR processSample purificationNucleic Acid AmplificationDetection
Two targets for NGNG confirmation with a single test
GeneXpert POC device
Specimens:― urine ― endocervical/vaginal swabs
Power supplyPortable machineEasy to useResults in 90 minutesTwo minutes hands on timeEach test cost equivalent to lab PCR test
GeneXpert POC device
Single use test cartridge
Urine specimen
Swab specimen
GeneXpert POC performance
Lab evaluation372 isolates
Field evaluationTwo health services200 samples
Sensivitity:100%Specificity: 99.5% (CT)100% (NG)
Sites– 12 Aboriginal health services
– QLD, WA and SA
– Remote/regional
– Test 150 people aged 16‐29yrs each year
Cross‐over RCT designRobust evidence
All health services receive the intervention
Each health service act as its own control
Primary outcomeRe‐infections
POC year Health services integrate
POC testing into client flow
Strategies for 90min wait STI management based on
POC result Treatment Partner notification Re‐testing at 3 months
(detect re‐infections) Standard lab testing Regular quality
improvement visits
Standard practice year
Standard lab testing STI management
based on lab result Treatment Partner notification Re‐testing at 3 months
(detect re‐infections)
Regular quality improvement visits
TTANGO quality management Monthly Quality Control (QC)
Two pos and neg specimens Results known
Bi‐annual External Quality Assurance Scheme (EQAS) Four pos and neg specimens Staff blinded Swabs
TTANGO training Training On‐site, flexible, 2‐3 days Competency assessment Certificate Manual Visual aids Real‐time remote support 3 visits from TTANGO coordinators
TTANGO progressTwo years preparationLab/field evaluationTraining manualsQuality management processesEthical and TGA approvalOngoing consultationLogisticsData collections systemsTrial commenced June 2013 First testing occurred last week
CT/NG POC test options
• Lateral flow• Detect antigen• Cheap• Single organism• Some only for swabs• Urine needs to be
centrifuged (20 mins)• Time to result: ~20 mins• Hands on time ~15 mins• Qualitative read