Abstract
BackgroundHigh prevalence rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) have been reported in Aboriginal people in remote and regional areas of Australia for well over two decades, and repeat positivity rates are high. To interrupt disease transmission and reduce the risk of complications, early diagnosis and treatment is important. However in many remote and regional areas there are long delays between testing for these curable sexually transmissible infections and providing treatment, due to both physical distance from laboratories and difficulties when recalling patients for subsequent management once results are available. Point-of-care (POC) tests have the potential to provide more timely diagnosis, to increase treatment and contact tracing, and in turn reduce CT and NG infection rates.Methods/designTTANGO (Test, Treat, ANd GO) is a cross-over cluster randomised controlled trial in 12 regional or remote Australian health services, which predominantly provide clinical services to Aboriginal people. The overall aim of TTANGO is to measure the clinical effectiveness, cost-effectiveness and cultural and operational acceptability of molecular POC testing for CT and NG infection. The primary outcome is repeat positivity at three months after treatment of an initial CT or NG infection.Participating health services will undertake the clinical management of CT and NG under two different modalities for one year each. In the first year, six health services will be randomly assigned to manage these infections under current diagnostic guidelines. The other six will supplement current diagnostic guidelines with POC testing, whereby diagnosis is made and subsequent treatment for those with positive POC tests is offered at the initial consultation. In the second year, the health services will cross over to the opposite management modality.TTANGO will be conducted over four years; 1.5 years of trial initiation and community consultation, 2 years of trial conditions and evaluation, and 6 months of data analysis and feedback.DiscussionTTANGO is the first cluster randomised trial of POC testing for CT and NG internationally. The results of this trial will provide crucial information to guide sexual health clinical practice in remote Aboriginal communities and other high prevalence settings.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12613000808741
Highlights
High prevalence rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) have been reported in Aboriginal people in remote and regional areas of Australia for well over two decades, and repeat positivity rates are high
Study design TTANGO is a crossover cluster randomised controlled trial set in 12 health services in regional or remote areas of Queensland, West Australia and South Australia (Figure 1: Study overview)
Six of the health services will be randomly assigned to manage these infections under current diagnostic guidelines
Summary
Rates of CT and NG in remote Aboriginal communities in Australia are unacceptably high, and TTANGO will evaluate whether POC testing for these STIs can improve the timeliness of treatment and in turn reduce repeat infection rates. Regular communication and training with trial sites from a dedicated TTANGO coordinator should help to mitigate this risk. Another challenge will be if the services randomised to the POC arm in the first year prefer to keep the POC machines due to realized improvements in STI management. This research is significant as study outcomes will make an important contribution to the international understanding of STI control using POC tests.
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