RecruitingACTRN12613000808741

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.


Sponsor

THE UNIVERSITY OF NEW SOUTH WALES, as represented by The Kirby Institute

Enrollment

1,800 participants

Start Date

Jun 14, 2013

Study Type

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

Sex: Both males and femalesMin Age: 16 YearssMax Age: 29 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether point-of-care (POC) testing — rapid tests for sexually transmitted infections done right in the clinic while the patient waits — can reduce the time it takes to diagnose and treat chlamydia and gonorrhoea in remote Aboriginal communities. Currently, test samples often have to be sent to a central laboratory, which can take a month or more. This delay means infected people may not get treated quickly, which increases the risk of complications and further spread. The trial is being run across remote health services in South Australia, Western Australia, and Queensland. You may be eligible if: - You are a health service located in a remote or very remote community - At least 10% of chlamydia and gonorrhoea tests in 16-to-29-year-olds are positive each year - The service tests at least 150 people aged 16–29 annually - The service has an electronic patient management system and sufficient staff capacity You may NOT be eligible if: - Your community has multiple overlapping health services serving the same Aboriginal and Torres Strait Islander population Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 b

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.


Locations(1)

QLD,SA,WA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12613000808741


Related Trials