Test, Treat ANd GO': a trial of point-of-care testing for sexually transmitted infections (STIs) in remote Aboriginal communities.
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.
THE UNIVERSITY OF NEW SOUTH WALES, as represented by The Kirby Institute
1,800 participants
Jun 14, 2013
Interventional
Conditions
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.
Eligibility
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Interventions
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.
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ACTRN12613000808741