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Molecular point-of-care testing for chlamydia and gonorrhoea in Indigenous Australians attending remote primary health services (TTANGO): A cluster-randomised, controlled, crossover trial

The Lancet Infectious Diseases Oct 04, 2018

Guy RJ, et al. - In this cluster-randomized crossover study, researchers investigated the efficacy of 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. The conclusions on the effect of the intervention on repeat infections could not be drawn as the retesting rates were too low. The investigators found that the use of molecular point-of-care tests could substantially reduce the 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.

Methods

  • Researchers performed a cluster-randomized crossover study recruiting primary health services in Western Australia, Far North Queensland, and South Australia that provide care to Indigenous people in regional or remote locations.
  • Services were included if they performed 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.
  • They randomly assigned services (1:1) using 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 proportion of people identified to have C. trachomatis or N. gonorrhoeae who had a positive result at retesting 3 weeks to 3 months after treatment was assessed as the primary outcome, and a treatment within 7 days—both in those aged 16–29 years and at the cluster level—was assessed as the secondary outcome.
  • They used data from all participants who had a positive result at testing, by point-of-care of laboratory testing (ie, the intention-to-treat population) for performing these analyses.

Results

  • Between June 1, 2013, and Feb 29, 2016, researchers enrolled 12 health services and randomly assigned them to standard care followed by intervention (six) and the reverse sequence (six).
  • After randomization, they excluded one health service initially assigned to standard care as it no longer met the inclusion criteria.
  • In the intervention group, 455 individuals tested positive for C. trachomatis or N. gonorrhoeae infection, and in the standard care group, 405 tested positive.
  • A positive test result was noted in 12 of 63 (19%) individuals retested in the intervention group, compared with 9 of 67 (13%) with positive retests in the standard care group (relative ratio [RR] 1.42, 95% CI: 0.64–3.13; P=0.405); 347 (76%) were treated within 7 days in the intervention group compared with 191 (47%) in the standard care group (RR 1.66, 95% CI: 1.41–1.93; P < 0.0001).
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