The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12613000808741
Ethics application status
Approved
Date submitted
15/07/2013
Date registered
23/07/2013
Date last updated
26/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
'Test, Treat ANd GO': a trial of point-of-care testing for sexually transmitted infections (STIs) in remote Aboriginal communities.
Scientific title
A randomised trial to evaluate whether point-of-care testing for chlamydia and gonorrhoea in remote Aboriginal communities can reduce repeat positivity at three months after treatment, among people with chlamydia or gonorrhoea infection.
Secondary ID [1] 282722 0
Nil
Universal Trial Number (UTN)
U1111-1144-9541
Trial acronym
TTANGO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chlamydia 289442 0
Gonorrhoea 289443 0
Condition category
Condition code
Infection 289769 289769 0 0
Sexually transmitted infections
Public Health 289770 289770 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design is a crossover, cluster randomised controlled trial in remote Aboriginal communities. A total of 12 remote health services (from Queensland, South Australia and West Australia) will be recruited to participate in the trial. Each health service will undertake the clinical management of chlamydia and gonorrhoea under two different modalities for one year each, in a randomly assigned order.
ARM 1:
In the first year, six of the health services will be randomly assigned to manage these infections under current diagnostic guidelines (“standard practice” phase or “control” phase).
ARM 2:
The other six health services will supplement current diagnostic guidelines with point-of-care (POC) testing (“POC” phase), such that diagnosis is made and subsequent treatment for those with positive POC tests is offered at the time of initial consultation. The POC device that will be used in the trial is the GeneXpert CT/NG (Registered trademark, Cepheid).
In the second year, the health services will cross over to the opposite management modality. Support with STI testing and management will be provided during both POC and standard practice periods of the trial. This will include support to increase opportunistic testing, and re-testing rates through optimising patient recall systems, and partner notification.
The GeneXpert is a new point-of-care diagnostic device based on molecular detection of infections and performs on par with routine laboratory based tests. The test can be performed on urine specimens, vaginal or cervical swab specimens.
Intervention code [1] 287385 0
Diagnosis / Prognosis
Intervention code [2] 287386 0
Early detection / Screening
Comparator / control treatment
The comparator is 'Standard practice'. This means that health services will undertake routine STI testing and management practices according to current guidelines.
Current guidelines are: for Far North Queensland - The Primary Clinical Care Manual, the Queensland STI Clinical Guidelines, Clinical Practice Guidelines for Sexual and Reproductive Health Nursing Officers; for Western Australia - Guidelines for Managing Sexually Transmitted Infections - The Silver Book; for South Australia- The CARPA Standard Treatment Manual and the Women's Business Manual.
These guidelines include screening, assessment, treatment, management, prevention and reporting recommendations. Clinicians are recommended to follow these guidelines on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 289855 0
1. Repeat positivity at three months after treatment among people with chlamydia (CT) or gonorrhoea (NG) infection.

At the re-test at three months the persistent CT and NG positivity rate will be calculated. The numerator is the number of individuals who tested positive for CT and NG and were re-tested within 1-3 months of treatment. The denominator is the number of positive CT and/or NG tests. The persistent positive rate will be stratified by infection, sex and age group (16-19, 20-24, 25-29 years).
This outcome will be calculated from CT/NG test data that will be extracted from health service patient management systems.
Timepoint [1] 289855 0
At the completion of the trial
Secondary outcome [1] 303388 0
1. Proportion of infections treated within seven days of specimen collection

The numerator is the number of individuals with true infections (who tested positive with NAAT) treated within seven days of the date the specimen was collected. The denominator is the number of individuals who tested positive with NAAT. The treatment interval will be stratified by infection, sex and age group (16-19, 20-24, 25-29).
Timepoint [1] 303388 0
At the completion of the trial
Secondary outcome [2] 303390 0
2. Cultural acceptability of POC tests to patients

Will be assessed by a descriptive analysis of feedback received from patients via a survey that was specifically designed for this study.
Timepoint [2] 303390 0
In the last month of the POC phase
Secondary outcome [3] 303391 0
3. Operational acceptability of POC tests to health service staff in remote community settings

Will be calculated by calculating the proportion of staff who reported they agreed or strongly agreed on the Likert scale with the acceptability questions in the staff questionnaire.
Timepoint [3] 303391 0
At the completion of the POC phase
Secondary outcome [4] 303392 0
4. Client flow in health services using POC test

Will be measured by coordinators observing the client flow to determine how the POC test was integrated in routine clinical practice.
Timepoint [4] 303392 0
At the completion of the POC phase
Secondary outcome [5] 303393 0
5. The cost effectiveness of the addition of POC testing to standard diagnostic procedures

The treatment interval and persistent positive rate data collected in this trial will enable us to parameterise the models. Our analyses will apply similar techniques to those used by other studies in the context of POC tests but explicitly represent Australian remote Aboriginal community settings. Our approach will extend previous work by developing a more realistic model based on simulated sexual networks rather than population averages. The mathematical approach will use an individual-based model to enable us to accurately simulate and track persistent positive infection rates, which is not possible with previous models. The epidemiological transmission models will project the estimated prevalence, incidence and persistent positivity rates expected from implementing POC tests in communities.

These model outputs will become inputs in a health economics analysis. The cost of using POC tests in remote health services including the increased clinician and patient waiting time for POC tests and the patient costs incurred in a return visit to the health service for medication after a positive test result will be directly measured in the trial. These data will be used to estimate the additional cost of implementing POC tests in combination with NAAT testing, compared to standard diagnostic procedures. Costs related to research will be excluded.

Then, the total costs associated with the widespread implementation of POC tests, including estimated logistical, clinical and administrative costs, will be compared with the long-term health and financial savings associated with their use (including the prevention of new infections, co-morbidities, and saving in reduced quality of life as well as costs of treatment saved due to decreased infections). As is standard with health economic analyses, discounting will be applied at levels of 0%, 3% and 5%. The health economic analyses will be carried out from the perspectives of the provider and the client. The integrated epidemiological and economic modelling will examine issues of allocation, efficiency, and cost-effectiveness.
Timepoint [5] 303393 0
At the completion of the trial
Secondary outcome [6] 303394 0
6. The sensitivity, specificity, negative and positive predictive value of the POC test in a field setting compared to the reference laboratory test

POC test performance will be assessed by comparing the results of the POC tests performed during the POC phase with the reference test (NAAT). These data can be sourced from the NAAT laboratory results imported into the health service database, and the POC test logbook kept at each site.
Timepoint [6] 303394 0
At the completion of the trial
Secondary outcome [7] 303395 0
7. A best practice model for quality management of STI/POC testing in remote health services.

A best practice model for quality management of STI/POC testing will be developed through synthesis of key stakeholder interview data and available literature.
Timepoint [7] 303395 0
At the completion of the trial

Eligibility
Key inclusion criteria
Health services that meet the following criteria:
* Located in communities classified as regional, remote or very remote by ABS
* At least 10% of CT and NG tests done are positive in 16-29 years olds in a year
* Annually offer CT and NG testing to a minimum of 150 people aged 16-29 years (or services have the capacity to do so);
* Agree to be randomly assigned in one year out of two to the ”POC” phase;
* Have an electronic patient management system; and
* Have the staff and resource capacity to fulfil protocol requirements.
Minimum age
16 Years
Maximum age
29 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Communities where there is a diverse range of health services that are accessed by Aboriginal and/or Torres Strait Islanders within the same location

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Unit of randomisation: Health services

Potential trial sites will be identified through consultation with the State Government Department’s of Health, peak bodies for Aboriginal Community Controlled Health Services or previous research experience with health services. Preliminary information will be sent to the Manager/CEO of the health services identified as being potentially eligible. Representatives of the study team will then contact the health services to discuss participation, and if they are interested, confirm eligibility. For those services that are deemed eligible and agree to be involved, Trial Coordinators will establish participatory and governance arrangements, as well as clear protocols and processes, through a Participatory Agreement. The agreement will be signed by a representative from the Aboriginal Community Controlled Health Service or the Government service and from the Kirby Institute.

Once a health service signs the participation agreement, they will be randomised to the intervention (“POC” phase) or control arm (“standard practice” phase) strategies. The randomisation sequence will be developed by the statistician at the Kirby Institute.

Concealment of allocation: The randomisation sequence for each trial cluster will be held by the statistician at the Kirby Institute. When a health service is ready for randomisation, the Trial Coordinator will contact the statistician via email and the statistician will then inform the coordinator if the health service will undertake POC testing in the first year or not.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Trial clusters will be randomised with 1:1 ratio. The randomisation scheme will be developed by the study Biostatistician according to the guidelines specified in the protocol. SAS implementation of randomisation will be used with RANUNI (generates random numbers between 0 and 1) function. A list of health care ID numbers will be prepared according to the guidelines specified in the study protocol. A randomisation code master list will be produced, and a paper copy signed and dated by the study Biostatistician.


Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We will compare results between the two years (with and without POC testing) from within the 150 patients aged 16-29 tested each year in participating health services. The primary endpoint of the study will be the health service specific difference between the two years in persistent positivity rates at three months, among the subset of participants in each year who were found by NAAT to have CT or NG infections at the time of study entry. The secondary endpoint will be: (i) health service specific difference between the two years in the proportion of true CT and NG infections that were treated within seven days of presentation. For both primary and secondary endpoints, the average difference between the two years (with and without POC tests) will be calculated across participating health services.
Power calculations were performed using the methods of Julious et al, for paired binary comparisons and Hayes et al for community randomised trials. We assumed the prevalence of CT and/or NG will be 15% at recruitment to the trial in each year, 30% will have a repeat infection within three months in the year that POC testing is not used and at least 150 patients aged 16-29 years will be tested at each health service each year. At least ten services will provide data in both the intervention and control arms. This will ensure 88% power to detect a decrease in CT and NG persistent positivity from 30% to 15%, and 78% power to detect a reduction from 20% to 10%. Conservatively, 12 services will selected for the trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA

Funding & Sponsors
Funding source category [1] 287497 0
Government body
Name [1] 287497 0
National Health and Medical Research Council
Address [1] 287497 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 287497 0
Australia
Primary sponsor type
University
Name
THE UNIVERSITY OF NEW SOUTH WALES, as represented by The Kirby Institute
Address
The CFI Building
Corner Boundary and West Streets
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 286234 0
None
Name [1] 286234 0
Address [1] 286234 0
Country [1] 286234 0
Other collaborator category [1] 277469 0
Other Collaborative groups
Name [1] 277469 0
Baker IDI, Central Australia
Address [1] 277469 0
W&E Rubuntja Research & Medical Education Building, Post Office Box 1294, Alice Springs, NT, 0871
Country [1] 277469 0
Australia
Other collaborator category [2] 277470 0
University
Name [2] 277470 0
The University of Queensland
Address [2] 277470 0
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Royal Children's Hospital, Brisbane
Back Road, off Bramston Terrace, Herston QLD 4029, AUSTRALIA
Country [2] 277470 0
Australia
Other collaborator category [3] 277471 0
University
Name [3] 277471 0
Department of Microbiology
Division of Laboratory Services
Faculty of Medicine, Dentistry and Health
Department of Obstetrics and Gynaecology,
The University of Melbourne
Address [3] 277471 0
University of Melbourne, Carlton 3053, Vic
Country [3] 277471 0
Australia
Other collaborator category [4] 277472 0
University
Name [4] 277472 0
Flinders University International Centre for Point-of-Care Testing
Address [4] 277472 0
Flinders University
Sturt Campus, West Wing, Level 3
Sturt Road, Bedford Park , South Australia 5042
Country [4] 277472 0
Australia
Other collaborator category [5] 277473 0
Other Collaborative groups
Name [5] 277473 0
The Burnet Institute

Address [5] 277473 0
85 Commercial Road, Melbourne, Victoria, Australia 3004
Country [5] 277473 0
Australia
Other collaborator category [6] 277474 0
Other Collaborative groups
Name [6] 277474 0
Apunipima Care York Health Council
Address [6] 277474 0
186 McCoombe Street
Bungalow, 4870, QLD
Country [6] 277474 0
Australia
Other collaborator category [7] 277475 0
Other Collaborative groups
Name [7] 277475 0
Ngaanyatjarra Health Service

Address [7] 277475 0
PO Box 644 (58 Head st), Alice Springs, NT 0871
Country [7] 277475 0
Australia
Other collaborator category [8] 277476 0
University
Name [8] 277476 0
Melbourne School of Population Health,The University of Melbourne
Address [8] 277476 0
University of Melbourne
580 Swanston St
Carlton 3053, Victoria
Country [8] 277476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289468 0
West Australian Aboriginal Health Information and Ethics Committee
Ethics committee address [1] 289468 0
2 Bulwer Street, PERTH WA 6000
PO Box 8493, Stirling Street, PERTH WA 6849
Ethics committee country [1] 289468 0
Australia
Date submitted for ethics approval [1] 289468 0
Approval date [1] 289468 0
14/11/2012
Ethics approval number [1] 289468 0
Ref # 412
Ethics committee name [2] 289469 0
Western Australia Country Health Service Research Ethics Committee
Ethics committee address [2] 289469 0
WACHS Research Ethics Committee
WA Country Health Service
1st Floor Bunbury Tower
61 Victoria Street
BUNBURY WA 6230
Ethics committee country [2] 289469 0
Date submitted for ethics approval [2] 289469 0
Approval date [2] 289469 0
23/05/2012
Ethics approval number [2] 289469 0
Ref # 2012/16
Ethics committee name [3] 289470 0
Cairns District Health Service Human Research Ethics Committees
Ethics committee address [3] 289470 0
Cairns & Hinterland Human Research Ethics Committee
PO Box 902
CAIRNS QLD, 4870
Ethics committee country [3] 289470 0
Australia
Date submitted for ethics approval [3] 289470 0
Approval date [3] 289470 0
25/02/2013
Ethics approval number [3] 289470 0
HREC/12/QCH/89 – 810.
Ethics committee name [4] 289471 0
Townsville District Health Service Human Research Ethics Committees
Ethics committee address [4] 289471 0
Townsville Human Research Ethics Committee
PO Box 670
TOWNSVILLE QLD, 4810
Ethics committee country [4] 289471 0
Australia
Date submitted for ethics approval [4] 289471 0
Approval date [4] 289471 0
10/09/2012
Ethics approval number [4] 289471 0
HREC/12/QTHS/133
Ethics committee name [5] 289472 0
Aboriginal Health Research Ethics Committee (South Australia)
Ethics committee address [5] 289472 0
Aboriginal Health Research Ethics Committee
PO Box 981,
Unley, SA 5061
Ethics committee country [5] 289472 0
Australia
Date submitted for ethics approval [5] 289472 0
Approval date [5] 289472 0
06/05/2013
Ethics approval number [5] 289472 0
# 04-13-500

Summary
Brief summary
Many remote Aboriginal communities experience high rates of curable sexually transmitted infections, with chlamydia and gonorrhoea being of particular importance. Untreated infection can lead to pelvic inflammatory disease and, over longer time periods, infertility, as well as increasing the potential for further transmission to sexual partners. Early diagnosis and timely treatment of STIs are therefore important from both a clinical and public health perspective. In many remote communities there may be considerable time, sometimes a month or more, between testing for STIs and the provision of treatment, primarily as a result of the time taken to transport and process specimens for routine testing at central laboratories. Once results are available and communicated back to the health centre, there may be further delays resulting from difficulty locating and recalling patients with infection back to the clinic for treatment.

Point-of-care (POC) tests are simple to use and are able to provide a diagnostic result using routinely collected specimens while a patient waits. For chlamydia and gonorrhoea this type of test could help reduce the time to treatment by providing test results in the clinic, soon after the sample is collected from the patient, ensuring that those with infection are treated promptly. Such tests could potentially result in great improvements in the management and control of these infections. Point-of-care tests for a variety of illnesses have been used widely in other countries, but have had limited use to date in Australia.

This project, the first of its kind in Australia- will trial the addition of POC testing to standard diagnostic procedures in remote communities. Health services in SA,WA and QLD will be recruited to participate in the trial. During the study, each health service will clinically manage chlamydia and gonorrhoea using two different approaches for one year each. In the first year, half of the health services will be randomly assigned to manage these infections under current guidelines (standard practice phase), and the other half will supplement standard guidelines with POC testing (POC phase), such that treatment is offered at the time of diagnosis for those found to be positive by the POC test. In the second year, the health services will cross over to the opposite management approach.

The overall aim of the TTANGO trial will be to see whether POC tests reduce the time to treatment, increase uptake of partner notifications and reduce the percentage of young people re-infected with chlamydia or gonorrhoea in remote communities in WA, SA and QLD. We will also examine the cost-effectiveness and cultural and operational acceptability of POC testing in remote health services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40986 0
A/Prof Rebecca Guy
Address 40986 0
The Kirby Institute
University of New South Wales
Cliffbrook Campus, 45 Beach Street, Coogee, NSW 2034, Australia
Country 40986 0
Australia
Phone 40986 0
+61 2 9385 0978
Fax 40986 0
Email 40986 0
Rguy@kirby.unsw.edu.au
Contact person for public queries
Name 40987 0
Ms Lisa Natoli
Address 40987 0
Burnet Institute
GPO Box 2284, Melbourne,
Victoria, Australia 3001
Country 40987 0
Australia
Phone 40987 0
61-3 92822136
Fax 40987 0
Email 40987 0
lisan@burnet.edu.au
Contact person for scientific queries
Name 40988 0
A/Prof Rebecca Guy
Address 40988 0
The Kirby Institute
University of New South Wales
Cliffbrook Campus, 45 Beach Street, Coogee, NSW 2034, Australia
Country 40988 0
Australia
Phone 40988 0
+61 2 9385 0978
Fax 40988 0
Email 40988 0
+61 2 9385 0978