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ObjectiveAboriginal women living in remote Australia experience a high burden of both chlamydia and gonorrhoea infections and disproportionately high rates of pelvic inflammatory disease (PID). We estimated for the first time the fraction of PID attributable to these infections in young Aboriginal women living in these settings.MethodsUsing published data from two large Australian studies (2002–2013; 2010–2014), we calculated the fraction of emergency department presentations and hospitalisations for PID attributable to chlamydia and/or gonorrhoea infection in Aboriginal women aged 16–29 years living in remote Australia. We used a Monte Carlo simulation to estimate the mean and 95% CIs for the assumed prevalence and population attributable fractions for PID for infection stratifications (chlamydia only, gonorrhoea only and dual infection) as well as for any infection (chlamydia and/or gonorrhoea). Additional outputs were calculated for chlamydia infection with/without gonorrhoea coinfection, and vice versa.ResultsThe prevalence of chlamydia only was 12.9% (95% CI: 11.6% to 14.2%), gonorrhoea only was 7.8% (95% CI: 6.6% to 8.9%) and dual infection was 6.5% (95% CI: 5.8% to 7.2%); rate ratios of PID were 1.9 (95% CI: 1.5 to 2.3), 5.2 (95% CI: 4.3 to 6.4) and 4.6 (95% CI: 3.8 to 5.5), respectively. The overall fraction of PID attributable to chlamydia and/or gonorrhoea was 40.2% (95% CI: 36.0% to 44.4%); any gonorrhoea was 33.4% (95% CI: 29.2% to 37.8%) and any chlamydia was 20.6% (95% CI: 16.9% to 24.6%).ConclusionOur study demonstrates the importance of calculating the fraction of PID related to chlamydia and gonorrhoea in the local context, demonstrating the major contribution gonorrhoea makes to PID hospitalisations among Australian Aboriginal women living in remote settings. To significantly and sustainably reduce the unacceptable rate of PID in this population, strategies are urgently needed to improve timely testing and treatment and recognition and management of PID in primary care.

ObjectivesPre-exposure prophylaxis (PrEP) is not commissioned within National Health Service (NHS) England. Individuals can access it privately online or by enrolment into a clinical trial. We established a list of individuals not enrolled in trials, awaiting PrEP. In response to the observation that patients awaiting PrEP trials were being referred with newly diagnosed HIV, we aimed to measure attendance, incident HIV, STI acquisition and missed opportunities for prevention.MethodsThe search was conducted for patients on the list from November 2017 to November 2019. We examined the electronic clinical records of those on the list and extracted demographic information, STI and HIV diagnoses. In addition, for those diagnosed with HIV, we reviewed risk factors including chemsex and prior postexposure prophylaxis.ResultsThere were 1073 patients on list, and 520 (48.6%) were still awaiting recruitment in a PrEP trial. Eight (0.75%) had an enrolment appointment booked while 200 (18.64%) had been contacted and deemed ineligible according to PrEP trial criteria. 45 (32.15%) had not responded to contact. We identified 15 new HIV infections in patients awaiting PrEP. Of these, 9/15 (60.00%) did not meet eligibility criteria at point of contact, though had been eligible at first referral.ConclusionIt is unacceptable that 15 patients acquired HIV while waiting. The individual lifetime cost of treating HIV is estimated at £360 800(1). This equals £5 412 000 for these 15 infections notwithstanding the psychological and physical burden. We advocate the immediate role out of universal PrEP for those who need it on the NHS. While this decision is delayed, harm is coming to those waiting. Wider provision of PrEP may encourage increased attendance, but must consider additional resources to accommodate added visits. We are relieved that at the point of final submission (21 March 2020) NHS England have recently announced funding of PrEP for eligible patients from, further details are pending.

ObjectivesA new molecular test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (GeneXpert CT/NG) has been demonstrated to be as accurate as conventional nucleic acid amplification tests (NAAT), but performance has not been evaluated in routine primary care, performed at the point of care by clinicians. We aimed to examine its diagnostic performance when used by clinicians in remote community health services in Australia with high prevalences of CT and NG infection. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#12613000808741)MethodsAt 12 health services, training was provided to 99 clinicians in the use of the GeneXpert CT/NG assay who tested specimens from all patients undergoing STI screening. Specimens were also sent in parallel for conventional laboratory-based NAATs and the concordance of results was evaluated.ResultsClinicians conducted 2486 tests: CT concordance was 99.4% (95% CI 99.1 to 99.7) with a positive concordance of 98.6% (95% CI 95.9 to 99.7) and negative concordance of 99.5% (95% CI 99.1 to 99.8); NG concordance was 99.9% (95% CI 99.7 to 100.0) with a positive concordance of 100.0% (95% CI 97.5 to 100.0) and negative concordance of 99.9% (95% CI 99.7 to 100.0).ConclusionsIn this first study reporting routine point-of-care use of GeneXpert CT/NG by primary care clinicians, we found excellent concordance with conventional NAATs. The use of the GeneXpert CT/NG at the point of care could potentially transform management and control of these infections in many endemic settings, including low/middle-income countries.

ObjectivesKey strategies to control chlamydia include testing, treatment, partner management and re-testing. We developed a diagnosis and care cascade for chlamydia to highlight gaps in control strategies nationally and to inform efforts to optimise control programmes.MethodsThe Australian Chlamydia Cascade was organised into four steps: (1) annual number of new chlamydia infections (including re-infections); (2) annual number of chlamydia diagnoses; (3) annual number of diagnoses treated; (4) annual number of diagnoses followed by a re-test for chlamydia within 42–180 days of diagnosis. For 2016, we estimated the number of infections among young men and women aged 15–29 years in each of these steps using a combination of mathematical modelling, national notification data, sentinel surveillance data and previous research studies.ResultsAmong young people in Australia, there were an estimated 248 580 (range, 240 690–256 470) new chlamydia infections in 2016 (96 470 in women; 152 100 in men) of which 70 164 were diagnosed (28.2% overall: women 43.4%, men 18.6%). Of the chlamydia infections diagnosed, 65 490 (range, 59 640–70 160) were treated (93.3% across all populations), but only 11 330 (range, 7660–16 285) diagnoses were followed by a re-test within 42–180 days (17.3% overall: women 20.6%, men 12.5%) of diagnosis.ConclusionsThe greatest gaps in the Australian Chlamydia Cascade for young people were in the diagnosis and re-testing steps, with 72% of infections undiagnosed and 83% of those diagnosed not re-tested: both were especially low among men. Treatment rates were also lower than recommended by guidelines. Our cascade highlights the need for enhanced strategies to improve treatment and re-testing coverage such as short message service reminders, point-of-care and postal test kits.

Background Disseminated Gonococcal Infection (DGI) is caused by Neisseria gonorrhoeae bacteraemia. Typically the primary source is a sexually acquired mucosal infection. If not recognised and treated promptly DGI can be associated with significant morbidity and, in rare cases, death. Central Australia has one of the highest rates of gonococcal notifications in Australia. Despite this, the nature and prevalence of complications arising from gonococcal infections within this at-risk population is unknown. Methods Enhanced surveillance and audit of patients with DGI discharged from Alice Springs Hospital between 2003 and 2012. Patient demographics and clinical management data were extracted from healthcare records and investigation databases. Results DGI cases were significantly more likely to present in young (≤29 years) Indigenous women compared with young Indigenous men (χ 2 , p=0.020). Overall Indigenous women had nearly twice the risk of DGI compared with men (relative risk 1.92 (95% CI 1.45 to 2.53)). The incidence of DGI per all gonococcal notifications on average was 911/100 000 (95% CI 717 to 1142) gonococcal notifications. Conclusions DGI represents a severe complication of N. gonorrhoeae infection. In Central Australia DGI is not a rare oddity but rather an important differential when dealing with patients with undefined sepsis and associated joint disease.

Objectives To undertake the first comprehensive analysis of the incidence of three curable sexually transmissible infections (STIs) within remote Australian Aboriginal populations and provide a basis for developing new control initiatives. Methods We obtained all results for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) testing conducted during 2009–2011 in individuals aged ≥16 years attending 65 primary health services across central and northern Australia. Baseline prevalence and incidence of all three infections was calculated by sex and age group. Results A total of 17 849 individuals were tested over 35 months. Baseline prevalence was 11.1%, 9.5% and 17.6% for CT, NG and TV, respectively. During the study period, 7171, 7439 and 4946 initially negative individuals had a repeat test for CT, NG and TV, respectively; these were followed for 6852, 6981 and 6621 person-years and 651 CT, 609 NG and 486 TV incident cases were detected. Incidence of all three STIs was highest in 16-year-olds to 19-year-olds compared with 35+ year olds (incident rate ratio: CT 10.9; NG 11.9; TV 2.5). In the youngest age group there were 23.4 new CT infections per 100 person-years for men and 29.2 for women; and 26.1 and 23.4 new NG infections per 100 person-years in men and women, respectively. TV incidence in this age group for women was also high, at 19.8 per 100 person-years but was much lower in men at 3.6 per 100 person-years. Conclusions This study, the largest ever reported on the age and sex specific incidence of any one of these three curable infections, has identified extremely high rates of new infection in young people. Sexual health is a priority for remote communities, but will clearly need new approaches, at least intensification of existing approaches, if a reduction in rates is to be achieved.

Objectives To determine the co-occurrence and epidemiological relationships of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) in a high-prevalence setting in Australia. Methods In the context of a cluster randomised trial in 68 remote Aboriginal communities, we obtained laboratory reports on simultaneous testing for CT, NG and TV by nucleic acid amplification tests in individuals aged ≥16 years and examined relationships between age and sex and the coinfection positivity. ORs were used to determine which infections were more likely to co-occur by demographic category. Results Of 13 480 patients (median age: 30 years; men: 37%) tested for all three infections during the study period, 33.3% of women and 21.3% of men had at least one of them, highest in patients aged 16–19 years (48.9% in women, 33.4% in men). The most frequent combination was CT/NG (2.0% of women, 4.1% of men), and 1.8% of women and 0.5% of men had all three. In all co-combinations, coinfection positivity was highest in patients aged 16–19 years. CT and NG were highly predictive of each other9s presence, and TV was associated with each of the other two infections, but much more so with NG than CT, and its associations were much stronger in women than in men. Conclusions In this remote high-prevalence area, nearly half the patients aged 16–19 years had one or more sexually transmitted infections. CT and NG were more common dual infections. TV was more strongly associated with NG coinfections than with CT. These findings confirm the need for increased simultaneous screening for CT, NG and TV, and enhanced control strategies. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12610000358044.

Objectives To examine the association between prior chlamydia and gonorrhoea infections and adverse obstetric outcomes. Methods Records of women resident in New South Wales, Australia with a singleton first birth during 1999–2008 were linked to chlamydia and gonorrhoea notifications using probabilistic linkage. Obstetric outcomes and potential confounders were ascertained from the birth record. Logistic regression, adjusted for potential confounders was used to estimate the association between a disease notification prior to the birth and adverse birth outcomes: spontaneous preterm birth (SPTB), small for gestational age (SGA) and stillbirth. Results Among 354 217 women, 1.0% (n=3658) had a prior chlamydia notification; 0.06% (n=196) had a prior gonorrhoea notification. The majority of notifications (>80%) occurred before the estimated conception date. 4.1% of women had a SPTB, 12.1% had a SGA baby and 0.6% of women had a stillbirth. Among women with a prior chlamydia notification, the risk of SPTB and stillbirth was increased, aOR 1.17 (95% CI 1.01 to 1.37) and aOR 1.40 (95% CI 1.00 to 1.96) respectively but there was no association with SGA, aOR 0.99 (95% CI 0.89 to 1.09). For women with gonorrhoea the risks for SPTB, stillbirth and SGA were respectively aOR 2.50 (95%CI 1.39 to 4.50), 2.35 (95% CI 0.58 to 9.56) and 0.98 (95% CI 0.58 to 1.68). Among women with a prior chlamydia diagnosis, the risk of SPTB did not differ between women diagnosed >1 year prior to conception, within the year prior to conception or during the pregnancy, (p=0.9). Conclusions Sexually transmissible infections in pregnancy and the preconception period may be important in predicting pregnancy outcomes.

Objectives Systematic review of the performance and operational characteristics of point-of-care (POC) tests for the diagnosis of Neisseria gonorrhoeae . Methods We searched PubMed and Embase until August 2010 using variations of the terms: ‘rapid test’, ‘ Neisseria gonorrhoeae ’ and ‘evaluation’. Results We identified 100 papers, 14 studies were included; nine evaluated leucocyte esterase (LE) dipsticks and three immunochromatographic strips, and two clinical audits of microscopy were identified. Of the field evaluations the gold standard was nucleic acid amplification technology in six studies and bacterial culture in the other six. In four studies, 50% or more of the patients were symptomatic. The median sensitivity of LE dipsticks was 71% (range 23–85%), median specificity was 70% (33–99%), median positive predictive value (PPV) was 19% (5–40%) and median negative predictive value (NPV) was 95% (56–99%). One LE study found a sensitivity of 23% overall, increasing to 75% in symptomatic women. LE dipsticks mostly involved three steps and took under 2 min. The median sensitivity of immunochromatographic tests (ICT) was 70% (60–94%), median specificity was 96% (89–97%), median PPV was 56% (55–97%) and median NPV was 93% (92–99%). Immunochromatic strips involved five to seven steps and took 15–30 min. Specificity of microscopy ranged from 38% to 89%. Conclusions ICT and LE tests had similar sensitivities, but sensitivity results may be overestimated as largely symptomatic patients were included in some studies. ICT had a higher specificity in women than LE tests. The findings highlight the need for improved POC tests for diagnosis of N gonorrhoeae and more standardised evaluations.

Introduction High CT and NG prevalences have been observed in remote Aboriginal communities for decades. Testing and treatment are key prevention strategies, yet considerable delays in treatment occur, due to distances from laboratories and difficulties recalling patients. The TTANGO (Test, Treat ANd GO) randomised controlled trial is the first to evaluate whether a new point-of-care CT/NG test (GeneXpert) can improve the timelines of treatment and reduce re-infections rates in remote Aboriginal communities. Methods In the context of TTANGO, we conducted an interim analysis to compare timelines of treatment before and after the point-of-care test was introduced at one of the 12 TTANGO sites. This site is one of seven remote clinics managed by Nganampa Health Council (NHC), an Aboriginal health service in South Australia. Results Overall, 777 people were tested for CT/NG, 81 (10.4%) were positive; highest in 15–19 year olds (15.4%). In the point-of-care period, 40/40 (100%, 95% CI: 91.1–100) of people with a positive CT/NG point-of-care test received treatment, and of these 90% were treated in 24 h, with a median time-to-treatment of 0 days. In the standard-care period, 40/41 (97.6%, 95% CI: 87.1–99.9) received treatment; 15 (37.5%) were treated presumptively on the same day (due to symptoms/risk) and 25 (62.5%) were treated on the basis of the laboratory test result; and of these 44% were treated in 1–7 days, 44% in 8–14 days and 12% in 15+ days, with a median time-to-treatment of 8 days. Conclusion This site is already part of a strong and comprehensive STI control program run by NHC over 20 years. Early findings from TTANGO show further improvement in STI management were achieved with point-of-care tests, with treatment occurring on average 8 days sooner for those treated on the basis of a test result. Future analyses will include all 12 clinics and also assess if re-infections have reduced. Disclosure of interest statement No pharmaceutical grants were received in the development of this study. TTANGO is funded by a NHMRC project grant. The GeneXpert cartridges were purchased from Cepheid and Cepheid provided machines on loan for the duration of the study.

Introduction New molecular-based point-of-care (POC) tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are being used for the first time by trained Aboriginal health workers/practitioners, registered/enrolled nurses and medical officers in regional/remote health services in Australia as part of TTANGO (Test, Treat ANd GO). We assessed the operational performance of the GeneXpert®CT/NG assay (Cepheid) POC test using conventional laboratory tests as the reference standard. Methods TTANGO, a randomised cross-over control trial of CT/NG POC testing, commenced June 2013. To date, 12 services have implemented GeneXpert testing on-site as routine practice, with specimens still sent to jurisdictional laboratories for conventional nucleic acid amplification testing (NAAT) as usual. We assessed the concordance of GeneXpert performed by health service staff with conventional laboratory NAAT. We also present selected details of discordant specimens. Results Among 1995 GeneXpert tests performed, CT and NG were detected in 182 and 127, respectively, by the jurisdictional laboratory. CT concordance was 99.4% (95% CI: 99.0 – 99.8) and NG was 99.9% (99.6–100.0). The fourteen discordant results (eight urines, six lower vaginal swabs) were identified in seven services and five laboratories (two use Cobas 4800, three use Aptima). Discordant results were predominantly CT (n = 12) and most (n = 10) were positive POC/negative laboratory results. The median POC test crossing point among CT discordants was 37.2 (IQR: 31.6–37.7) with five of nine (55.6%) having crossing points >35, compared to 29.2 (IQR: 26.3–32.6) among CT concordants with 10 of 179 (5.5%) having crossing points >35. The two NG discordant results were both positive POC/negative laboratory results. Conclusion The performance of GeneXpert in the hands of trained health service staff is excellent and consistent with previous laboratory and field evaluations. Higher crossing points of discordant results most likely indicates low organism loads close to test detection threshold and seem unrelated to service, laboratory, specimen type or reference assay. Overall, results show the GeneXpert method is suitable for routine detection of CT and NG. Disclosure of interest statement No conflicts of interest declared. No financial support was received by Cepheid. Cepheid has provided GeneXpert devices on loan for the duration of TTANGO and test cartridges at a reduced rate.

Introduction The GeneXpert test system is a molecular test used to diagnose Chlamydia trachomatis and Neisseria gonorrhoeae at the point-of-care (POC). It is being used in remote Aboriginal health services in Australia as part of the TTANGO (Test, Treat, ANd GO) Trial. Methods In 2014 we interviewed 15 Aboriginal health workers/practitioners and nurses from 6 health services participating in TTANGO. Most were female (53%), 70% had worked >5 years in the remote sector and 40% were Aboriginal. We explored factors known to influence POC test acceptability including perceived ease of use and usefulness, and staff attitudes- which are all mediated by a range of barriers and enablers to POC test use. Results Most staff found the GeneXpert both easy to use and useful in their setting. They indicated that POC testing has improved STI management, resulting in more timely and targeted treatment, earlier commencement of partner notification, and reduced time and effort associated with client recall. Staff expressed confidence in POC test results and in treating patients on this basis. They reported greater job satisfaction- feeling more in control of STI testing and patient health. Access to the GeneXpert appeared to legitimise or create an entry point to discussing STIs with clients, particularly for Aboriginal health workers. As most clients opted to return for test results (after 90 min) POC testing did not impact negatively on client flow. Managing positive test results in a shorter time frame was sometimes challenging. Manual documentation of results was considered to be onerous by some, who suggested that enhanced connectivity between the GeneXpert and patient management system could assist. Conclusion Participants identified the potential for the GeneXpert to strengthen STI control in remote communities. Test acceptability was high, although some challenges remain and will inform future scale up/translation of POC testing in this setting. Disclosure of interest statement No conflicts of interest declared. No financial support was received by Cepheid. Cepheid has provided GeneXpert devices on loan for the duration of TTANGO and test cartridges at a reduced rate.

Background The latest nucleic acid amplification tests (NAAT) for gonorrhoea are convenient and accurate, and are often used in place of culture-based tests for diagnosis. However the increasing use of NAATs in remote settings in Australia has compromised surveillance for gonorrhoea antimicrobial resistance (AMR). A molecular resistance test that can make use of samples collected for NAAT diagnosis may provide a means to enhance surveillance in remote settings where the availability of samples suitable for culture-based AMR testing is declining. We used a mathematical model to assess the potential benefit of a molecular test in terms of the timeliness of detection of gonorrhoea AMR. Methods An individual-based mathematical model was developed to describe the transmission of gonorrhoea in a remote Indigenous population in Australia. We estimated the impact of the molecular test on the time delay between first importation and the first confirmation that the prevalence of gonorrhoea AMR has breached the WHO-recommended 5% threshold (when a change in antibiotic should occur). Results The model suggests that when culture is the only means of testing for AMR, the breach will only be detected when the actual prevalence of AMR in the population has already reached 8 – 18%. With the addition of a molecular AMR test and assuming AMR can be determined for all samples, the breach will be detected when the actual prevalence of AMR in the population has reached 6%, which only slightly exceeds the recommended notification threshold of 5%. Conclusion Molecular tests have the potential to provide more timely warning of the emergence of gonorrhoea AMR in remote settings where surveillance is compromised by the increased use of NAATs for diagnosis. This in turn will facilitate earlier treatment switching and more targeted treatment, which has the potential to reduce the population impact of gonorrhoea AMR. Disclosure of interest statement This work was supported by National Health and Medical Research Council Project Grants (APP1025517). The National Neisseria Network is funded by the Australian Government Department of Health. The Kirby Institute is funded by the Australian Government Department of Health and Ageing and is affiliated with the Faculty of Medicine, University of New South Wales. The views expressed in this publication do not necessarily represent the position of the Australian Government.

Background Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG) are endemic in many remote Australian Aboriginal communities. Clinical guidelines in remote areas recommend annual sexual health testing generally in 15 – 35 year olds, yet little is known about the extent of annual testing in remote health services or factors that predict it. Methods We used baseline 2009–2010 laboratory data from 67 remote Aboriginal communities in four regions participating in a cluster randomised trial aiming to improve sexual health service delivery. We defined and calculated annual testing as the percentage of individuals with an initial negative CT/NG test that had a repeat test at 12 months, +/- 3 months. Using logistic regression we determined client and health service factors associated with an annual test. Results Among 6318 females recorded as testing negative for CT/NG, 24% had an annual test (highest in 16 –19 year olds at 26%), compared with 15% of 4241 males (highest in 20–24 year olds at 19%). Factors independently and significantly (p 90% of clients Aboriginal (AOR:1.4.95% CI: 1.2–1.6), services having an electronic medical record system (AOR:1.7.95% CI: 1.4–2.1), services using a centralised recall system (AOR:1.3.95% CI: 1.1–1.6), services being community controlled (health centre governance controlled by a local Aboriginal board) (AOR:1.4, 95% CI: 1.2–1.6) and Aboriginal health worker/s employed (AOR1.4.95% CI: 1.0 –1.9). Conclusions Our analysis identified both client and service related factors associated with higher levels of annual testing. Having Aboriginal staff members and systems which support patient recall were key factors identified for services that are amenable to change. While some factors may be indirect markers of other characteristics of the health centres or clients, these findings will help guide support to services in remote areas.

Introduction Control of sexually transmissible infections (STIs) can be compromised by delays in time to diagnosis and treatment. Point-of-care (POC) tests can provide results at time of consultation. We conducted field evaluations of three POC tests (one new molecular-based and two best-performing immunochromatographic tests [ICT] identified from preliminary laboratory evaluations) for diagnosis of gonorrhoea (NG) and chlamydia (CT) at selected remote health services in Australia to identify the most suitable device for a larger randomised trial. Methods Urine specimens collected from patients attending health services for routine STI screening were aliquotted and tested onsite with: GeneXpert® CT/NG (simultaneous detection of CT and NG), Diaquick CT (CT only), and Gonorrhea Card (NG only). We compared results to routine laboratory reference results (commercial nucleic-acid amplification test) and calculated sensitivity (Sn) and specificity (Sp) by standard methods. We assessed selected operational characteristics. Results For GenXpert (n = 99): Sn and Sp for CT were: 100% (95% confidence interval [CI]: 56.1–100) and 98.9% (CI: 93.1–99.9); for NG: 100% (CI: 56.1–100) and 100% (CI: 95.0–100). For Diaquick (n = 50), Sn and Sp were: 42.9% (CI: 11.8–79.8) and 97.7% (CI: 86.2–99.9). For Gonorrhea Card (n = 15), Sn and Sp were: 66.7% (CI: 12.5–98.2) and 75.0% (CI: 42.8–93.3). Urine volume required: GeneXpert = 1ml; both ICTs = 15ml. Mean preparation time: GeneXpert = 1 minute and ICTs = 18 minutes. Time to result: GeneXpert = 88 minutes, Diaquick = 10 minutes and Gonorrhea Card = 15 minutes. Results from additional evaluation sites occurring in early 2013 will also be presented. Conclusions The GeneXpert is highly accurate for detection of CT and NG from urine in these field settings. Similar performance has been reported from the laboratory. Despite longer time to results than traditional ICTs, the exceptional accuracy and operational benefits makes the GeneXpert device appealing for use where delays to treatment are frequent. This device will be further evaluated in a cluster-randomised controlled trial (TTANGO) to commence mid-2013.

Aim Studies have demonstrated and quantified the relationship between chlamydia infection and pelvic inflammatory disease (PID). However there is relatively little information regarding the rate of PID following gonorrhoea infection. This analysis compares the rate of hospitalisation for PID following a diagnosis of gonorrhoea to the rate following a chlamydia diagnosis. Method All women, aged 15–45 years, in New South Wales (NSW), with a diagnosis of chlamydia or gonorrhoea between 1/7/2000 and 31/12/2008 were followed for up to one year after diagnosis for hospitalisations for PID. The incidence rates of PID hospitalisation among women with a chlamydia or gonorrhoea diagnosis were compared to the whole of the NSW population using standardised incidence ratios (SIRs). Poisson regression was used to compare the rates of PID hospitalisation after adjusting for age, diagnosis date, socioeconomic group, area of residence and prior births. Results There were 38379 women with a chlamydia diagnosis. During 35014 person years of follow-up (PYFU), 485 were hospitalised for PID; incidence rate (IR) 13.8 per 1000 PYFU (95% CI 12.6–15.1). Among 1023 women with a gonorrhoea diagnosis, during 895 PYFU 45 were hospitalised for PID; (IR 50.3 per 1000 PYFU, 95% CI 35.6–65.0). Compared to the age-equivalent NSW female population, the incidence of PID hospitalisation was 27.0 (95% CI 24.4–29.8) times greater among women who had a chlamydia diagnosis in the year prior to hospitalisation and 95.8 (95% CI 64.2–137.6) times greater among women with a gonorrhoea diagnosis. Younger age, diagnosis prior to 2005, socioeconomic disadvantage and prior births were also associated with an increased rate of PID hospitalisation. Conclusion Hospitalisation rates for PID were over 3 times greater in women diagnosed with gonorrhoea than chlamydia, and rates in both were substantially higher than in the general female population. Our results suggest that gonorrhoea causes more serious reproductive health sequelae than chlamydia.

Introduction Australia has a widely dispersed network of public sexual health services that see large numbers of people at risk of genital Chlamydia trachomatis infection. ACCESS was established to monitor chlamydia testing and positivity rates nationally and to assist the interpretation of chlamydia diagnoses reported through passive surveillance. We report on chlamydia testing and positivity in Aboriginal and Torres Strait Islander (hereafter Aboriginal) people attending 18 sexual health services participating in ACCESS between 2006 and 2011. Methods Using line-listed data, we analysed Aboriginal status reporting, testing rates based on first visits and chlamydia positivity in those tested. Outcomes were stratified by age group, sex, and year of attendance and were compared with non-Indigenous clients using a chi-square test and multivariate logistic regression (p < 0.05). Results From 2006 to 2011, 7,103 (4.2%) Aboriginal people and 161,626 (95.8%) non-Indigenous people attended participating sexual health services for an initial visit. Of the Aboriginal people 5,280 (74%) were tested for chlamydia. The positivity rates in Aboriginal people were 17.0% in women (23.3% in 15–19 year olds and 18.9% in 20–24 year olds) and 17.3% in men (20.2% in 15–19 year olds and 24.3% in 20–24 year olds). There were increasing trends seen in chlamydia positivity in Aboriginal and Torres Strait Islander females and non-Indigenous males and females between 2006 and 2011 (p-trend < 0.01). On multivariate analysis, positivity was associated with younger age, being heterosexual and living in Queensland in both Aboriginal men and women. In addition, in Aboriginal men, positivity was associated with not living in a remote area, and not having sex overseas; and in Aboriginal women, it was associated with attending in 2010 or 2011. Conclusion The high Chlamydia positivity rates and increases over time highlight the need for enhanced prevention and screening programmes in Aboriginal people in Australia.

Introduction Strain-typing and characterisation of associated resistance mechanisms is pivotal to understanding the development and spread of Neisseria gonorhoeae (NG) antimicrobial resistance (AMR). In Australia, we have embarked on a national study to determine the molecular basis of AMR in our local isolates with a view to implementing broad-based molecular surveillance for NG AMR. Methods In this initial phase of the study, called GRAND (Gonorrhoea Resistance Assessment via Nucleic acid Detection), we are using the Sequenom MassARRAY iPLEX MALDI-TOF MS platform to characterise all available isolates (n = 2373) collected throughout Australia in the first half of 2012. To date, two iPLEX methods have been developed and validated: (1) a typing method targeting 14 informative SNPs previously shown to predict an MLST type; and (2) an AMR method targeting 11 common mutations associated with N. gonorrhoeae resistance to penicillin, ciprofloxacin, azithromycin and ceftriaxone, including important mutations on the penicillin binding protein (PBP2): A501 substitutions and the mosaic PBP2 sequence. Results The results to date show that the technology is well suited for high-throughput typing of N. gonorhoeae isolates. In particular, we found it can be used on heat-denatured isolates (removing the need for a commercial DNA extraction kit) and can genotype (using both iPLEX reactions) up to 384 isolates within one working day for less than $AUS20.00 (€15.00) per isolate. Conclusions The data from this study will provide pivotal information to inform the implementation of molecular-based NG AMR surveillance. Validation and testing is ongoing.

The emergence of antimicrobial resistance (AMR) among sexually transmitted infections (STI) is a cause for global concern, and is epitomised by the fact we are now running out of treatment options for gonorrhoea. The role of AMR surveillance is now more important than ever. Ideally, AMR surveillance should be fast, easy, inexpensive, accessible, reproducible across testing methods, and provide clinically meaningful information to inform treatment strategies. In reality this is not the case, with AMR surveillance activities for STIs typically weak or non-existent in many parts of the world. Molecular methods have the potential to enhance AMR surveillance, particularly for organisms that cannot easily or readily be characterised phenotypically; which is the case for most STIs. The challenges for molecular surveillance are however many and include factors such as; the mechanisms of resistance may be many or otherwise unknown, they may miss novel mutations, the technology can be expensive, they need specialised laboratories and trained staff, and that their specificity can be undermined where target sequences are shared across different species. Despite these challenges, such methods are being developed and are now finding their way into routine settings. Advances in molecular technology and expanding knowledge of resistance mechanisms continue to pave new directions in this important area.

Background Remote Aboriginal communities in Australia have substantially higher rates of chlamydia (CT), gonorrhoea (NG) and trichomoniasis (TV) diagnosis compared with non-Indigenous people, despite many years of programme and policy aimed at reducing disparity. Methods ‘STRIVE’ is a stepped wedge cluster randomised controlled trial, underway in 68 remote Aboriginal communities. The primary objective is to assess if a sexual health quality improvement programme within primary care clinics improves STI management and in turn reduces STI prevalence. Data is extracted from both patient management systems and from laboratories. To evaluate the impact of the trial, the largest STI prevalence study in Aboriginal people has been undertaken twice. Results In the first year of the trial, testing rates have improved overall by 27% at 21 sites and by 50% or more at 11 sites. In 2011, baseline prevalences for CT and NG (n = 2483) and TV (n = 1848) among 16–34 year olds were 9%, 7% and 13% respectively. Highest prevalences were reported among 16–19 year olds for CT 13% (95% CI; 10.8–16.4), NG, 12% (95% CI; 9.7–15.1) and TV, 17%(95% CI; 13.7–21.1). There were 17,848 STI tests conducted in 2010 and among females aged 16–34; 33.3% had ≥ 1 STI (highest in 16–19 year olds: 48.9%) and 21.3% of males had ≥ 1 STI (highest in 16–19 year olds:33.4%). The most frequent co-infection was CT and NG which was found in 3.4% of females (highest in 16–19 year olds: 8.6%) and 3.9% of males (highest in 16–19 year olds:10.1%). Discussion STRIVE has provided information not previously available in regard to a comprehensive epidemiological picture of STI morbidity and health service responses in remote Aboriginal communities and highlights work required especially among young people. The results of STRIVE may be of relevance to other areas globally with STI endemic rates.

Introduction In many settings, control of sexually transmissible infections (STIs) is compromised by lack of laboratory infrastructure, physical distance from laboratories and loss to follow up of patients. Point-of-care (POC) tests have the potential to provide timely diagnosis, treatment and partner notification, and in turn reduce infection rates. In April 2013, we will implement the first cluster randomised trial of chlamydia and gonorrhoea POC testing in remote Aboriginal communities where STIs are endemic. Methods The study, called TTANGO (test, treat and go), will measure the effectiveness, cost-effectiveness and cultural and operational acceptability of POC testing for chlamydia and gonorrhoea infections. The study design is a crossover, cluster, randomised controlled trial involving 12 health services in remote Aboriginal communities in Australia. The primary outcome is the percentage of people with persistent chlamydia and gonorrhoea positive tests. The trial runs for 2 years and is a partnership between research, government and community organisations. Results TTANGO is reaching the conclusion of the preparation phase and has achieved significant steps, including the engagement of remote health services and communities, a comprehensive laboratory and field evaluation to select the ideal assay, development of the first formal training package for chlamydia and gonorrhoea POC testing, and a quality assurance programme. The GeneXpert® CT/NG molecular POC assay was selected for the trial as it showed very high sensitivity and specificity compared to other assays, was easy to use and results were available in approximately 90 minutes. This paper will discuss progress in preparing and implementing TTANGO, the methodology and evaluation. Conclusion The results of this RCT will provide crucial information to guide sexual health clinical practise in remote Aboriginal communities and other settings internationally. Mathematical modelling and health economic analyses will be used to make the case for large scale implementation of this technology.