Background: Timely diagnosis and treatment of sexually transmissible infections will prevent morbidity and onward transmission. We aimed to assess the efficacy of a point-of-care molecular test for Chlamydia trachomatis and Neisseria gonorrhoeae infections at the cluster level to improve infection management among Indigenous Australian communities with high prevalence of sexually transmissible infections. Methods: In this cluster-randomised crossover study, we recruited primary health services in Western Australia, Far North Queensland, and South Australia that provide care to Indigenous people in regional or remote locations. The services were eligible if they did 150 or more tests for C trachomatis or N gonorrhoeae infection per year among individuals aged 16–29 years, and if C trachomatis or N gonorrhoeae positivity was 10% or higher. Services were randomly assigned (1:1) by use of a random-number generator, stratified by geographical region, to either standard care conditions with routine laboratory-based sexually transmissible infection testing for 12 months followed by 12 months of intervention with molecular point-of-care testing, or the reverse sequence. The primary outcome was the proportion of people (aged 16–29 years) found to have C trachomatis or N gonorrhoeae who had a positive result at retesting 3 weeks to 3 months after treatment, and a secondary outcome was treatment within 7 days, both in those aged 16–29 years and at the cluster level. We did these analyses using data from all participants who had a positive result at testing, by point-of-care of laboratory testing (ie, the intention-to-treat population). The trial is registered with Australian and New Zealand Clinical Trials Registry (ACTRN12613000808741). Findings: Between June 1, 2013, and Feb 29, 2016, 12 health services were enrolled and randomly assigned to standard care followed by intervention (six) and the reverse sequence (six). After randomisation, one health service that was initially assigned to standard care was excluded because it no longer met the inclusion criteria. 455 individuals tested positive for C trachomatis or N gonorrhoeae infection in the intervention group, and 405 tested positive in the standard care group. In the intervention group, 12 (19%) of 63 individuals retested had a positive test result, compared with nine (13%) of 67 with positive retests in the standard care group (relative ratio [RR] 1·42, 95% CI 0·64–3·13; p=0·405), and 347 (76%) were treated within 7 days in the intervention group, compared with 191 (47%) in the standard care group (RR 1·66, 1·41–1·93; p<0·0001). Interpretation: Retesting rates were too low to draw conclusions on the effect of the intervention on repeat infections. Further research will be needed to determine whether point-of-care tests have an effect on reinfection rates, and the sustainability of using this technology. However, our findings show that time to treatment of C trachomatis or N gonorrhoeae infections in primary care clinics in remote areas in Australia with a high prevalence of sexually transmissible infections could be substantially reduced by the use of molecular point-of-care tests.
|Number of pages||10|
|Journal||The Lancet Infectious Diseases|
|Publication status||Published - Oct 2018|
Bibliographical noteFunding Information:
Funding for the Test Treat and Go (TTANGO) trial was provided by Australian National Health and Medical Council awards (NHMRC Project Grant 1009902 and Program grant 568971). TTANGO is a collaboration between researchers named in the author list, the participating health services in Queensland (ie, the Queensland Aboriginal and Islander Health Council, Apunipima Cape York Health Council, and Queensland Health), Western Australia (the Aboriginal Health Council of Western Australia, Kimberley Aboriginal Medical Services, Ngaanyatjarra Health Service, and West Australia Department of Health), and South Australia (the Aboriginal Health Council of South Australia and South Australia Health). We thank the National Reference Laboratory and Medical Communication Associates for their support. We thank Cepheid for their generous in-kind support with supply of GeneXpert devices and assay cartridges at a reduced price. We thank all participating health services and their staff for their commitment to the study and we thank our collaborating partners for their ongoing support and advice. We thank Rae-Lin Huang (Nganampa Health Council) for her expertise and contributions, including the extraction of deidentified testing data from two sites. We also thank the members of the TTANGO Reference Group who are not otherwise named as coauthors: Donna Mak, Russell Waddell, Joseph Debattista, Fleur Francis, Tony Coburn, and Jacqueline Mein. We also thank Western Diagnostic Pathology, WA; PathWest Laboratory Medicine, WA; Clinipath Pathology, WA; Pathology Queensland, QLD; Sullivan Nicolaides Pathology, QLD; and SA Pathology, SA; and their staff who did the laboratory testing on behalf of the participating health services, and provided the anonymous line record data for the trial. We thank Lara Motta (International Centre for Point-of-Care Testing, Flinders University, Adelaide, SA, Australia), for developing the training manual and associated training resources in collaboration with the TTANGO coordinators, and Laila Khawar (Kirby Institute, UNSW, Sydney, NSW, Australia) for her assistance in the clinical audit and data cleaning.
© 2018 Elsevier Ltd