BMC Infectious Diseases | |
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 | |
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.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20150402174256173.pdf | 433KB | download | |
Figure 1. | 99KB | Image | download |
【 图 表 】
Figure 1.
【 参考文献 】
- [1]Bowden FJ, Tabrizi SN, Garland SM, Fairley CK: Infectious diseases. 6: Sexually transmitted infections: new diagnostic approaches and treatments. Med J Aust 2002, 176(11):551-557.
- [2]Oakeshott P, Kerry S, Aghaizu A, Atherton H, Hay S, Taylor-Robinson D, et al.: Randomised controlled trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial. BMJ 2010, 8(340):c1642.
- [3]Katz B, Thom S, Blythe M, Arno J, Caine V, Jones R: Fertility in adolescent women previously treated for genitourinary chlamydial infection. Adolesc Pediatr Gynecol 1994, 7:147-152.
- [4]Low N, Egger M, Sterne JA, Harbord RM, Ibrahim F, Lindblom B, et al.: Incidence of severe reproductive tract complications associated with diagnosed genital chlamydial infection: the Uppsala Women’s cohort study. Sex Transm Infect 2006, 82(3):212-218.
- [5]Bradshaw N, Flood-Shaffer K, Rodriguez E, Johnson-Rubio A, Porter K, Prien S: Early outcomes from the west Texas early pregnancy and chlamydia project: potential impact on future fertility. Fertil Steril 2004, 82(Supplement 2):S15-S.
- [6]Allaire A, Huddleston J, Graves W, Nathan L: Initial and repeat screening for chlamydia trachomatis during pregnancy. Infectious Diseases in Obstetrics and Gynaecology 1998, 6:116-122.
- [7]Centers for Disease Control and Prevention: Sexually transmitted diseases treatment guidelines, 2006. MMWR 2006, 55(RR-11):1-94.
- [8]The Kirby Institute: Bloodborne Viral and Sexually Transmitted Infections in Aboriginal and Torres Strait Islander People. Surveillance and Evaluation Report 2012 Sydney. The University of New South Wales: The Kirby Institute; 2012.
- [9]Australian Bureau of Statistics: 2012 Year Book Australia, cat. no. 1301.0. Canberra: ABS; 2012.
- [10]Kildea S, Bowden FJ: Reproductive health, infertility and sexually transmitted infections in indigenous women in a remote community of the Northern Territory. Aust N Z J Public Health 2000, 24:382-386.
- [11]Skov S, Parnaby M, Dempsey K, Morgan S: Pelvic Inflammatory Disease (PID), Infertility and Syphilis in the Darwin Remote Region - Unpublished Report. NT Department of Health and Community Services: Darwin; 2000.
- [12]Mein J, Bowden FJ: A profile of inpatient STD-related pelvic inflammatory disease in the Top End of the northern territory of Australia. Med J Aust 1997, 166:464-467.
- [13]Centre for Disease Control: NT Guidelines for the Management of Sexually Transmitted Infections in the Primary Health Care Setting. Darwin: Northern Territory Government Department of Health and Families; 2008.
- [14]Directorate CDC: Guidelines for Managing Sexually Transmitted Infections. Perth: Department of Health, Western Australia; 2006.
- [15]Fagan P: Sexual health service provision in remote aboriginal and Torres strait islander settings in far north Queensland: sexual health symptoms and some outcomes of partner notification. Venereology 2001, 14(2):55-61. 2001;14(2):55–61
- [16]CARPA: CARPA Standard Treatment Manual. 5th edition. Alice Springs: Central Australian Rural Practitioners Association Inc; 2009.
- [17]Alary M, Gbenafa-Agossa C, Aina G, Ndour M, Labbe AC, Fortin D, et al.: Evaluation of a rapid point-of-care test for the detection of gonococcal infection among female sex workers in Benin. Sex Transm Infect 2006, 82(Suppl 5):v29-v32.
- [18]Dallabetta GA, Gerbase AC, Holmes KK: Problems, solutions, and challenges in syndromic management of sexually transmitted diseases. Sex Transm Infect 1998, 74(Suppl 1):S1-S11. Epub 1999/02/19
- [19]Farley TA, Cohen DA, W. E: Asymptomatic sexually transmitted diseases: the case for screening. Prev Med 2003, 36(4):502-509.
- [20]Cecil JA, Howell MR, Tawes JJ, Gaydos JC, McKee KT Jr, Quinn TC, et al.: Features of chlamydia trachomatis and Neisseria gonorrhoeae infection in male army recruits. J Infect Dis 2001, 184(9):1216-1219. Epub 2001/10/13
- [21]Korenromp EL, Sudaryo MK, de Vlas SJ, Gray RH, Sewankambo NK, Serwadda D, et al.: What proportion of episodes of gonorrhoea and chlamydia becomes symptomatic? Int J STD AIDS 2002, 13(2):91-101. Epub 2002/02/13
- [22]Huang RL, Torzillo PJ, Hammond VA, Coulter ST, Kirby AC: Epidemiology of sexually transmitted infections on the anangu pitjantjatjara yankunytjatjara lands: results of a comprehensive control program. Med J Aust 2008, 189(8):442-445. Epub 2008/10/22
- [23]Guy R, Ward JS, Smith KS, Su JY, Huang RL, Tangey A, et al.: The impact of sexually transmissible infection programs in remote aboriginal communities in Australia: a systematic review. Sex Health 2012, 9(3):205-212. Epub 2012/06/16
- [24]Chen MY, Ryder N, Donovan B: Completeness and timeliness of treatment for chlamydia within a sexual health service. Int J STD AIDS 2004, 15(11):762-764. Epub 2004/11/13
- [25]Regan DG, Wilson DP, Hocking JS: Coverage is the key for effective screening of chlamydia trachomatis in Australia. J Infect Dis 2008, 198(3):349-358. Epub 2008/07/01
- [26]Hocking J, Fairley C, Bradshaw C, Chen M, Donovan B, ST: Chlamydia Incidence and Re-Infection Rates Study (CIRIS). Melbourne: University of Melbourne [commissioned by the Chlamydia Targetted Grants Program, Commonwealth Department of Health & Ageing; 2009.
- [27]Morre SA, van den Brule AJC, Rozendaal L, Boeke AJP, Voorhorst FJ, de Blok S: The natural course of asymptomatic chlamydia trachomatis infections. International journal of STD & AIDS 2002, 13(Supplement 1):12.
- [28]Garnett GP, Mertz KJ, Finelli L, Levine WC, St Louis ME: The transmission dynamics of gonorrhoea: modelling the reported behaviour of infected patients from Newark, New Jersey. Philosophical transactions of the Royal Society of London Series B, Biological sciences 1999, 354(1384):787-797. Epub 1999/06/12
- [29]Hook EW 3rd, Spitters C, Reichart CA, Neumann TM, Quinn TC: Use of cell culture and a rapid diagnostic assay for chlamydia trachomatis screening. JAMA 1994, 272(11):867-870. Epub 1994/09/21
- [30]Geisler WM, Wang C, Morrison SG, Black CM, Bandea CI, Hook EW 3rd: The natural history of untreated chlamydia trachomatis infection in the interval between screening and returning for treatment. Sex Transm Dis 2008, 35(2):119-123. Epub 2007/09/28
- [31]Batteiger BE, Tu W, Ofner S, Van Der Pol B, Stothard DR, Orr DP, et al.: Repeated chlamydia trachomatis genital infections in adolescent women. J Infect Dis 2010, 201(1):42-51. Epub 2009/11/26
- [32]Walker J, Tabrizi SN, Fairley CK, Chen MY, Bradshaw CS, Twin J, et al.: Chlamydia trachomatis incidence and re-infection among young women–behavioural and microbiological characteristics. PLoS One 2012, 7(5):e37778. Epub 2012/06/05
- [33]Su JY, Rahman S, Mactaggart W, Davis B, Chelemella P, Broadfoot J: Prevalence of Repeat Infection with Chlamydia and Gonorrhoea in Central Australia 2005–2009. Canberra: Australasian Sexual Health Conference; 2011.
- [34]Shephard MD: Cultural and clinical effectiveness of the 'QAAMS’ point-of-care testing model for diabetes management in Australian aboriginal medical services. The Clinical biochemist Reviews / Australian Association of Clinical Biochemists 2006, 27(3):161-170. Epub 2007/02/03
- [35]Shephard MDS, Gill J: P. The national QAAMS program – a practical example of PoCT working in the community. Clin Biochem Rev V. 2010, 31:95-99.
- [36]Watchirs Smith LA, Hillman R, Ward J, Whiley DM, Causer L, Skov S, et al.: Point-of-care tests for the diagnosis of Neisseria gonorrhoeae infection: a systematic review of operational and performance characteristics. Sex Transm Infect 2013, 89(4):320-326. Epub 2012/10/25
- [37]van Dommelen L, van Tiel FH, Ouburg S, Brouwers EE, Terporten PH, Savelkoul PH, et al.: Alarmingly poor performance in chlamydia trachomatis point-of-care testing. Sex Transm Infect 2010, 86(5):355-359. Epub 2010/09/30
- [38]Peeling RW: Applying new technologies for diagnosing sexually transmitted infections in resource-poor settings. Sex Transm Infect 2011, 87(Suppl 2):ii28-ii30. Epub 2011/12/14
- [39]Hui BB, Wilson DP, Ward JS, Guy RJ, Kaldor JM, Law MG, et al.: The potential impact of new generation molecular point-of-care tests on gonorrhoea and chlamydia in a setting of high endemic prevalence. Sex Health 2013, 10(4):348-356. Epub 2013/06/29
- [40]Peeling RW: Utilisation of rapid tests for sexually transmitted infections: promises and challenges Open. Infec Dis J 2009, 3:156-163.
- [41]The Australian Bureau of Statistics: The ASGC Remoteness Structure. 2006. http://www.abs.gov.au/websitedbs/d3310114.nsf/home/remoteness+structure webcite
- [42]Tabrizi SN, Unemo M, Golparian D, Twin J, Limnios AE, Lahra M, et al.: Analytical evaluation of GeneXpert CT/NG, the first genetic point-of-care assay for simultaneous detection of Neisseria gonorrhoeae and chlamydia trachomatis. J Clin Microbiol 2013, 51(6):1945-1947. Epub 2013/04/05
- [43]Causer LM, Hengel B, Natoli L, Tangey A, Badman S, Tabrizi S: Field Evaluation of Three Point-of-Care Tests for Chlamydia and Gonorrhoea in Remote Health Services in Australia. Vienna: STI and AIDS World Congress; 2013.
- [44]Gaydos CA, Van Der Pol B, Jett-Goheen M, Barnes M, Quinn N, Clark C, et al.: Performance of the Cepheid CT/NG xpert rapid PCR test for detection of chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol 2013, 51(6):1666-1672. Epub 2013/03/08
- [45]Smith DW, Tapsall JW, Lum G: Guidelines for the use and interpretation 189 of nucleic acid detection tests for Neisseria gonorrhoeae in Australia: a position paper on behalf of the public health laboratory network. Commun Dis Intell 2005, 29:358-365.
- [46]Queensland Government: Primary Clinical Care Manual. 2011. http://www.health.qld.gov.au/pccm/ webcite
- [47]Government of Western Australia Department of Health: Guidelines for Managing Sexually Transmitted Infections - WA. 2012. http://silverbook.health.wa.gov.au/ webcite
- [48]Cabuang LM, Costa AM, Tabrizi SN, Vincini GA, Best SJ: Utility of swab samples in EQAS for CTNG and HSV-1/2 NAT testing. Canberra, Australia: 28th Annual NRL Workshop on Infectious Diseases; 2011.
- [49]Julious SA, Campbell MJ, Altman DG: Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat 1999, 9(2):241-251.
- [50]Hayes RJ, Bennett S: Simple sample size calculation for cluster-randomized trials. Int J Epidemiol 1999, 28(2):319-326.
- [51]Vickerman P, Watts C, Alary M, Mabey D, Peeling RW: Sensitivity requirements for the point of care diagnosis of chlamydia trachomatis and Neisseria gonorrhoeae in women. Sex Transm Infect 2003, 79(5):363-367.
- [52]Gift TL, Pate MS, Hook EW 3rd, Kassler WJ: The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for chlamydia trachomatis. Sex Transm Dis 1999, 26(4):232-240. Epub 1999/05/04
- [53]Guy R, Hocking J, Low N, Ali H, Bauer HM, Walker J, et al.: Interventions to increase rescreening for repeat chlamydial infection. Sex Transm Dis 2012, 39(2):136-146. Epub 2012/01/18
- [54]Shephard MD, Spaeth B, Mazzachi BC, Auld M, Schatz S, Loudon J, et al.: Design, implementation and initial assessment of the northern territory point-of-care testing program. The Australian journal of rural health 2012, 20(1):16-21. Epub 2012/01/19