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

BMC Infectious Diseases

John M Kaldor⁹  David Anderson⁶  David Wilson⁹  David G Regan⁹  Mark Shephard⁴  Handan Wand⁹  Annie Tangey⁸  Steven B Badman⁹  Christopher K Fairley⁷  Basil Donovan⁹  Sepehr N Tabrizi⁵  David Whiley²  Belinda Hengel¹  Louise Causer⁹  James Ward³  Lisa Natoli⁶  Rebecca J Guy⁹ 

[1] Apunipima Cape York Health Council, Cairns, Queensland, Australia;Queensland Paediatric Infectious Diseases (QPID) Laboratory, Queensland Children’s Medical Research Institute, The University of Queensland, Queensland, Australia;Baker IDI, Alice Springs, Northern Territory, Alice Springs, Northern Territory, Australia;Flinders University International Centre for Point of-Care Testing, Flinders University, Adelaide, South Australia, Australia;Department of Obstetrics and Gynaecology, The Royal Women’s Hospital and Murdoch Childrens Research Institute, University of Melbourne, Parkville, Victoria, Australia;The Burnet Institute, Melbourne, Australia;Melbourne Sexual Health Centre, Melbourne, Victoria, Australia;Ngaanyatjarra Health Service, Alice Springs, Northern Territory, Australia;The Kirby Institute, University of New South Wales, Sydney, Australia

关键词: Randomized controlled trial;    Sexually transmitted infections;    Point-of-care testing;   

Others  :  1145688
DOI  :  10.1186/1471-2334-13-485

 received in 2013-10-02, accepted in 2013-10-14,  发布年份 2013

【 摘 要 】

Background

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. 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/design

TTANGO (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.

Discussion

TTANGO 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 registration

Australian and New Zealand Clinical Trials Registry ACTRN12613000808741

【 授权许可】

   
2013 Guy et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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