A randomised trial of point-of-care tests for chlamydia and gonorrhoea infections in remote Aboriginal communities: Test, Treat ANd GO- the “TTANGO” trial protocol

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

Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation

“…The TTANGO trial15 aimed to evaluate the public health and health service impact of POC testing for STIs. ‘POC test’ and ‘POC testing’ here refer to GeneXpert and its use by clinicians at the POC, under the definition that includes diagnostics providing accurate results and facilitating treatment within the same clinical visit,23 which accurately describes the intent here.…”

“…Under the cluster randomised crossover trial design of TTANGO,15 12 remote health services were enrolled and randomly assigned to either standard care (routine laboratory testing) or standard care plus POC testing for 1 year before crossing to the other modality for another year. Service eligibility criteria are described elsewhere 15.…”

“…Service eligibility criteria are described elsewhere 15. The recommended target group for testing followed clinical guidelines (annual screening of 15–30 year-olds),24 however all patients presenting to the health service and offered STI testing at the clinician’s discretion were eligible.…”

“…These findings are encouraging, but do not exclude the possibility that processing errors may arise if clinicians are required to integrate testing into their busy and demanding routine workload. The TTANGO (Test, Treat and Go) trial,15 taking place in 12 remote Australian Aboriginal communities, is the first investigation of the GeneXpert CT/NG test’s integration into routine primary health practice performed by clinicians. From the TTANGO trial we have previously reported on the high levels of acceptability and policy implications of this technology in these settings16 17 and a novel quality control (QC) method implemented 18.…”

Chlamydia point-of-care diagnostics: caveat emptor

“…POC tests offer the advantage of accurate treatment for those patients with a positive result, including those who do not have symptoms, which may treat more individuals than when a more sensitive test that requires a return visit is used 10. While the POC assays described in the study by Hurly provided no clinical benefit compared to syndromic management, newer commercially available molecular assays, and assays in development, may have substantially better performance and, thus, have the potential to provide much needed rapid diagnostics in remote or resource-constrained settings 11. Thus, while we should be cautious and not rely solely on the information provided in package inserts, there is reason for optimism in the field of rapid STI diagnostics.…”