External Quality Assessment (EQA) for SARS-CoV-2 RNA Point-of-Care Testing in Primary Healthcare Services: Analytical Performance over Seven EQA Cycles.

In April 2020, the Aboriginal and Torres Strait Islander COVID-19 Point-of-Care (POC) Testing Program was initiated to improve access to rapid molecular-based SARS-CoV-2 detection in First Nations communities. At capacity, the program reached 105 health services across Australia. An external review estimated the program contributed to averting between 23,000 and 122,000 COVID-19 infections within 40 days of the first infection in a remote community, equating to cost savings of between AU$337 million and AU$1.8 billion. Essential to the quality management of this program, a customised External Quality Assessment (EQA) program was developed with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP). From July 2020 to May 2022, SARS-CoV-2 EQA participation ranged from 93 to 100%. Overall concordance of valid EQA results was high (98%), with improved performance following the first survey. These results are consistent with those reported by 12 Australian and 4 New Zealand laboratories for three SARS-CoV-2 RNA EQA surveys in March 2020, demonstrating that SARS-CoV-2 RNA POC testing in primary care settings can be performed to an equivalent laboratory analytical standard. More broadly, this study highlights the value of quality management practices in real-world testing environments and the benefits of ongoing EQA program participation.

A decentralised point-of-care testing model to address inequities in the COVID-19 response.

The COVID-19 pandemic is growing rapidly, with over 37 million cases and more than 1 million deaths reported by mid-October, 2020, with true numbers likely to be much higher in the many countries with low testing rates. Many communities are highly vulnerable to the devastating effects of COVID-19 because of overcrowding in domestic settings, high burden of comorbidities, and scarce access to health care. Access to testing is crucial to globally recommended control strategies, but many communities do not have adequate access to timely laboratory services. Geographic dispersion of small populations across islands and other rural and remote settings presents a key barrier to testing access. In this Personal View, we describe a model for the implementation of decentralised COVID-19 point-of-care testing in remote locations by use of the GeneXpert platform, which has been successfully scaled up in remote Aboriginal and Torres Strait Islander communities across Australia. Implementation of the decentralised point-of-care testing model should be considered for communities in need, especially those that are undertested and socially vulnerable. The decentralised testing model should be part of the core global response towards suppressing COVID-19.

Establishment of a sentinel surveillance network for sexually transmissible infections and blood borne viruses in Aboriginal primary care services across Australia: the ATLAS project.

BACKGROUND: Sexually transmissible infection (STI) and blood-borne virus (BBV) diagnoses data are a core component of the Australian National Notifiable Diseases Surveillance System (NNDSS). However, the NNDSS data alone is not enough to understand STI and BBV burden among priority population groups, like Aboriginal and Torres Strait Islander people, because it lacks testing, treatment and management data. Here, we describe the processes involved in establishing a STI and BBV sentinel surveillance network representative of Aboriginal Community-Controlled Health Services (ACCHS)-known as the ATLAS network-to augment the NNDSS and to help us understand the burden of disease due to STI and BBV among Aboriginal and Torres Strait Islander peoples. METHODS: Researchers invited participation from ACCHS in urban, regional and remote areas clustered in five clinical hubs across four Australian jurisdictions. Participation agreements were developed for each clinical hub and individual ACCHS. Deidentified electronic medical record (EMR) data relating to STI and BBV testing, treatment and management are collected passively from each ACCHS via the GRHANITEtm data extraction tool. These data are analysed centrally to inform 12 performance measures which are included in regular surveillance reports generated for each ACCHS and clinical hub. RESULTS: The ATLAS network currently includes 29 ACCHS. Regular reports are provided to ACCHS to assess clinical practice and drive continuous quality improvement initiatives internally. Data is also aggregated at the hub, jurisdictional and national level and will be used to inform clinical guidelines and to guide future research questions. The ATLAS infrastructure can be expanded to include other health services and potentially linked to other data sources using GRHANITE. CONCLUSIONS: The ATLAS network is an established national surveillance network specific to Aboriginal and Torres Strait Islander peoples. The data collected through the ATLAS network augments the NNDSS and will contribute to improved STI and BBV clinical care, guidelines and policy program-planning.

Population-level diagnosis and care cascade for chlamydia in Australia.

OBJECTIVES: Key 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. METHODS: The 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. RESULTS: Among 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. CONCLUSIONS: The 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.

Strategies to improve control of sexually transmissible infections in remote Australian Aboriginal communities: a stepped-wedge, cluster-randomised trial.

BACKGROUND: Remote Australian Aboriginal communities have among the highest diagnosed rates of sexually transmissible infections (STIs) in the world. We did a trial to assess whether continuous improvement strategies related to sexual health could reduce infection rates. METHODS: In this stepped-wedge, cluster-randomised trial (STIs in remote communities: improved and enhanced primary health care [STRIVE]), we recruited primary health-care centres serving Aboriginal communities in remote areas of Australia. Communities were eligible to participate if they were classified as very remote, had a population predominantly of Aboriginal people, and only had one primary health-care centre serving the population. The health-care centres were grouped into clusters on the basis of geographical proximity to each other, population size, and Aboriginal cultural ties including language connections. Clusters were randomly assigned into three blocks (year 1, year 2, and year 3 clusters) using a computer-generated randomisation algorithm, with minimisation to balance geographical region, population size, and baseline STI testing level. Each year for 3 years, one block of clusters was transitioned into the intervention phase, while those not transitioned continued usual care (control clusters). The intervention phase comprised cycles of reviewing clinical data and modifying systems to support improved STI clinical practice. All investigators and participants were unmasked to the intervention. Primary endpoints were community prevalence and testing coverage in residents aged 16-34 years for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. We used Poisson regression analyses on the final dataset and compared STI prevalences and testing coverage between control and intervention clusters. All analyses were by intention to treat and models were adjusted for time as an independent covariate in overall analyses. This study was registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12610000358044. FINDINGS: Between April, 2010, and April, 2011, we recruited 68 primary care centres and grouped them into 24 clusters, which were randomly assigned into year 1 clusters (estimated population aged 16-34 years, n=11 286), year 2 clusters (n=10 288), or year 3 clusters (n=13 304). One primary health-care centre withdrew from the study due to restricted capacity to participate. We detected no difference in the relative prevalence of STIs between intervention and control clusters (adjusted relative risk [RR] 0·97, 95% CI 0·84-1·12; p=0·66). However, testing coverage was substantially higher in intervention clusters (22%) than in control clusters (16%; RR 1·38; 95% CI 1·15-1·65; p=0·0006). INTERPRETATION: Our intervention increased STI testing coverage but did not have an effect on prevalence. Additional interventions that will provide increased access to both testing and treatment are required to reduce persistently high prevalences of STIs in remote communities. FUNDING: Australian National Health and Medical Research Council.

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

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. FUNDING: The National Health and Medical Research Council, Australia.

Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation.

OBJECTIVES: A 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) METHODS: At 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. RESULTS: Clinicians 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). CONCLUSIONS: In 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.

Perspectives of primary health care staff on the implementation of a sexual health quality improvement program: a qualitative study in remote aboriginal communities in Australia.

BACKGROUND: Young people living in remote Australian Aboriginal communities experience high rates of sexually transmissible infections (STIs). STRIVE (STIs in Remote communities, ImproVed and Enhanced primary care) was a cluster randomised control trial of a sexual health continuous quality improvement (CQI) program. As part of the trial, qualitative research was conducted to explore staff perceptions of the CQI components, their normalisation and integration into routine practice, and the factors which influenced these processes. METHODS: In-depth semi-structured interviews were conducted with 41 clinical staff at 22 remote community clinics during 2011-2013. Normalisation process theory was used to frame the analysis of interview data and to provide insights into enablers and barriers to the integration and normalisation of the CQI program and its six specific components. RESULTS: Of the CQI components, participants reported that the clinical data reports had the highest degree of integration and normalisation. Action plan setting, the Systems Assessment Tool, and the STRIVE coordinator role, were perceived as adding value to the program, but were less readily integrated or normalised. The remaining two components (dedicated funding for health promotion and service incentive payments) were seen as least relevant. Our analysis also highlighted factors which enabled greater integration of the CQI components. These included familiarity with CQI tools, increased accountability of health centre staff and the translation of the CQI program into guideline-driven care. The analysis also identified barriers, including high staff turnover, limited time involved in the program and competing clinical demands and programs. CONCLUSIONS: Across all of the CQI components, the clinical data reports had the highest degree of integration and normalisation. The action plans, systems assessment tool and the STRIVE coordinator role all complemented the data reports and allowed these components to be translated directly into clinical activity. To ensure their uptake, CQI programs must acknowledge local clinical guidelines, be compatible with translation into clinical activity and have managerial support. Sexual health CQI needs to align with other CQI activities, engage staff and promote accountability through the provision of clinic specific data and regular face-to-face meetings. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000358044 . Registered 6/05/2010. Prospectively Registered.

Patient, staffing and health centre factors associated with annual testing for sexually transmissible infections in remote primary health centres.

BACKGROUND: In high-incidence Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) settings, annual re-testing is an important public health strategy. Using baseline laboratory data (2009-10) from a cluster randomised trial in 67 remote Aboriginal communities, the extent of re-testing was determined, along with the associated patient, staffing and health centre factors. METHODS: Annual testing was defined as re-testing in 9-15 months (guideline recommendation) and a broader time period of 5-15 months following an initial negative CT/NG test. Random effects logistic regression was used to determine factors associated with re-testing. RESULTS: Of 10559 individuals aged ≥16 years with an initial negative CT/NG test (median age=25 years), 20.3% had a re-test in 9-15 months (23.6% females vs 15.4% males, P<0.001) and 35.2% in 5-15 months (40.9% females vs 26.5% males, P<0.001). Factors independently associated with re-testing in 9-15 months in both males and females were: younger age (16-19, 20-24 years); and attending a centre that sees predominantly (>90%) Aboriginal people. Additional factors independently associated with re-testing for females were: being aged 25-29 years, attending a centre that used electronic medical records, and for males, attending a health centre that employed Aboriginal health workers and more male staff. CONCLUSIONS: Approximately 20% of people were re-tested within 9-15 months. Re-testing was more common in younger individuals. Findings highlight the importance of recall systems, Aboriginal health workers and male staff to facilitate annual re-testing. Further initiatives may be needed to increase re-testing.

High chlamydia and gonorrhoea repeat positivity in remote Aboriginal communities 2009-2011: longitudinal analysis of testing for re-infection at 3 months suggests the need for more frequent screening.

Background Extremely high rates of diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) have been recorded in remote communities across northern and central Australia. Re-testing at 3 months, after treatment administered, of CT or NG is recommended to detect repeat infections and prevent morbidity and ongoing transmission. METHODS: Baseline CT and NG laboratory data (2009-2010) from 65 remote health services participating in a cluster randomised trial was used to calculate the proportion of individuals re-tested after an initial CT or NG diagnosis at <2 months (not recommended), 2-4 months (recommended) and 5-12 months and the proportion with repeat positivity on re-test. To assess if there were difference in re-testing and repeat positivity by age group and sex, t-tests were used. RESULTS: There was a total of 2054 people diagnosed with CT and/or NG in the study period; 14.9% were re-tested at 2-4 months, 26.9% at 5-12 months, a total of 41.8% overall. Re-testing was higher in females than in males in both the 2-4-month (16.9% v. 11.5%, P<0.01) and 5-12-month (28.9% v. 23.5%, P=0.01) periods. Women aged 25-29 years had a significantly higher level of re-testing 5-12 months post-diagnosis than females aged 16-19 years (39.8% v. 25.4%, P<0.01). There was a total of 858 people re-tested at 2-12 months and repeat positivity was 26.7%. There was higher repeat NG positivity than repeat CT positivity (28.8% v. 18.1%, P<0.01). CONCLUSIONS: Just under half the individuals diagnosed with CT or NG were re-tested at 2-12 months post-diagnosis; however, only 15% were re-tested in the recommended time period of 2-4 months. The higher NG repeat positivity compared with CT is important, as repeat NG infections have been associated with higher risk of pelvic inflammatory disease-related hospitalisation. Findings have implications for clinical practice in remote community settings and will inform ongoing sexual health quality improvement programs in remote community clinics.

"I Do Feel Like a Scientist at Times": A Qualitative Study of the Acceptability of Molecular Point-Of-Care Testing for Chlamydia and Gonorrhoea to Primary Care Professionals in a Remote High STI Burden Setting.

BACKGROUND: Point-of-care tests for chlamydia (CT) and gonorrhoea (NG) could increase the uptake and timeliness of testing and treatment, contribute to improved disease control and reduce reproductive morbidity. The GeneXpert (Xpert CT/NG assay), suited to use at the point-of-care, is being used in the TTANGO randomised controlled trial (RCT) in 12 remote Australian health services with a high burden of sexually transmissible infections (STIs). This represents the first ever routine use of a molecular point-of-care diagnostic for STIs in primary care. The purpose of this study was to explore the acceptability of the GeneXpert to primary care staff in remote Australia. METHODS: In-depth qualitative interviews were conducted with 16 staff (registered or enrolled nurses and Aboriginal Health Workers/Practitioners) trained and experienced with GeneXpert testing. Interviews were digitally-recorded and transcribed verbatim prior to content analysis. RESULTS: Most participants displayed positive attitudes, indicating the test was both easy to use and useful in their clinical context. Participants indicated that point-of-care testing had improved management of STIs, resulting in more timely and targeted treatment, earlier commencement of partner notification, and reduced follow up efforts associated with client recall. Staff expressed confidence in point-of-care test results and treating patients on this basis, and reported greater job satisfaction. While point-of-care testing did not negatively impact on client flow, several found the manual documentation processes time consuming, suggesting that improved electronic connectivity and test result transfer between the GeneXpert and patient management systems could overcome this. Managing positive test results in a shorter time frame was challenging for some but most found it satisfying to complete episodes of care more quickly. CONCLUSIONS: In the context of a RCT, health professionals working in remote primary care in Australia found the GeneXpert highly acceptable. These findings have implications for use in other primary care settings around the world.

Reasons for delays in treatment of bacterial sexually transmissible infections in remote Aboriginal communities in Australia: a qualitative study of healthcentre staff.

UNLABELLED: Background Remote Aboriginal communities in Australia experience high rates of bacterial sexually transmissible infections (STIs). To control the transmission and decrease the risk of complications, frequent STI testing combined with timely treatment is required, yet significant delays in treatment have been reported. Perceived barriers to timely treatment for asymptomatic patients in remote communities were explored. METHODS: A qualitative study was undertaken as part of the STRIVE (STIs in Remote communities, ImproVed and Enhanced primary health care) project; a cluster randomised controlled trial of a sexual health quality improvement program. During 2012, we conducted 36 in-depth interviews with staff in 22 clinics in remote Australia. RESULTS: Participants included registered nurses (72%) and Aboriginal health practitioners (28%). A key barrier to timely treatment was infrequent transportation of specimens to laboratories often hundreds of kilometres away from clinics. Within clinics, there were delays checking and actioning test results, and under-utilisation of systems to recall patients. Participants also described difficulties in physically locating patients due to: (i) high mobility between communities; and (ii) low levels of community knowledge created by high staff turnover. Participants also suggested strategies to overcome some barriers such as dedicated clinical time to follow-up recalls and taking treatment out to patients. CONCLUSIONS: Participants identified barriers to timely STI treatment in remote Aboriginal communities, and systems to address some of the barriers. Innovative strategies such as point-of-care testing or increased support for actioning results, coupled with incentives to individual patients to attend for results, may also assist in decreasing the time to treatment.

Chlamydia and gonorrhoea point-of-care testing in Australia: where should it be used?

UNLABELLED: Background Diagnoses of chlamydia and gonorrhoea have increased steadily in Australia over the past decade. Testing and treatment is central to prevention and control but in some settings treatment may be delayed. Testing at the point of care has the potential to reduce these delays. We explored the potential utility of newly available accurate point-of-care tests in various clinical settings in Australia. METHODS: In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with sexual health, primary care, remote Aboriginal health and laboratory expertise. RESULTS: Participants reported that point-of-care testing would have greatest benefit in remote Aboriginal communities where prevalence of sexually transmissible infections is high and treatment delays are common. Some suggested that point-of-care testing could be useful in juvenile justice services where young Aboriginal people are over-represented and detention periods may be brief. Other suggested settings included outreach (where populations may be homeless, mobile or hard to access, such as sex workers in the unregulated sex industry and services that see gay, bisexual and other men who have sex with men). Point-of-care testing could also improve the consumer experience and facilitate increased testing for sexually transmissible infections among people with HIV infection between routine HIV-management visits. Some participants disagreed with the idea of introducing point-of-care testing to urban services with easy access to pathology facilities. CONCLUSIONS: Participants felt that point-of-care testing may enhance pathology service delivery in priority populations and in particular service settings. Further research is needed to assess test performance, cost, acceptability and impact.

Barriers and facilitators of sexually transmissible infection testing in remote Australian Aboriginal communities: results from the Sexually Transmitted Infections in Remote Communities, Improved and Enhanced Primary Health Care (STRIVE) Study.

UNLABELLED: Background Remote Australian Aboriginal communities experience high rates of bacterial sexually transmissible infections (STI). A key strategy to reduce STIs is to increase testing in primary health care centres. The current study aimed to explore barriers to offering and conducting STI testing in this setting. METHODS: A qualitative study was undertaken as part of the STI in Remote communities, Improved and Enhanced Primary Health Care (STRIVE) project; a large cluster randomised controlled trial of a sexual health quality improvement program. We conducted 36 in-depth interviews in 22 participating health centres across four regions in northern and central Australia. RESULTS: Participants identified barriers including Aboriginal cultural norms that require the separation of genders and traditional kinship systems that prevent some staff and patients from interacting, both of which were exacerbated by a lack of male staff. Other common barriers were concerns about client confidentiality (lack of private consulting space and living in small communities), staff capacity to offer testing impacted by the competing demands for staff time, and high staff turnover resulting in poor understanding of clinic systems. Many participants also expressed concerns about managing positive test results. To address some of these barriers, participants revealed informal strategies, such as team work, testing outside the clinic and using adult health checks. CONCLUSIONS: Results identify cultural, structural and health system issues as barriers to offering STI testing in remote communities, some of which were overcome through the creativity and enthusiasm of individuals rather than formal systems. Many of these barriers can be readily addressed through strengthening existing systems of cultural and clinical orientation and educating staff to view STI in a population health framework. However others, particularly issues in relation to culture, kinship ties and living in small communities, may require testing modalities that do not rely on direct contact with health staff or the clinic environment.

A field evaluation of a new molecular-based point-of-care test for chlamydia and gonorrhoea in remote Aboriginal health services in Australia.

UNLABELLED: Background Point-of-care (POC) tests could be important public health tools in settings with treatment delays and high rates of sexually transmissible infections (STIs). Use is limited due to suboptimal performance. The performance and ease-of-use of a new molecular-based POC test for simultaneous detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) was assessed, alongside two single-organism immunochromatographic tests (ICT). METHODS: The evaluation occurred between May 2012 and March 2013 during community STI screens in two remote Aboriginal health services. Urine was tested with the GeneXpert(®)CT/NG and if sufficient volume, also with Diaquick CT and Gonorrhoea Card. The gold standard comparison was laboratory nucleic acid amplification testing (NAAT). Operational characteristics were also assessed. RESULTS: Among 198 samples, GeneXpert CT sensitivity and specificity was 100% [95% confidence intervals (CI): 75.9-100] and 99.5% (95% CI: 96.5-100), and NG was 100% (95% CI: 96.5-100) and 100% (95% CI: 97.5-100), respectively. Among a sample subset, Diaquick CT (n=104) sensitivity and specificity was 27.3% (95% CI: 7.3-60.7) and 66.7% (95% CI: 12.5-98.2), and Gonorrhoea Card (n=29), was 66.7% (95% CI: 12.5-98.2) and 76.9% (95% CI: 56.0-90.2), respectively. GeneXpert required 1mL of urine, four steps, 1min specimen preparation and 90min to result. ICTs required 15mL of urine, eight steps, 18min preparation and 10-15min to result. CONCLUSION: The accuracy and operational benefits of GeneXpert CT/NG make it very suitable in these settings where delays to treatment are encountered.

Coinfection with Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis: a cross-sectional analysis of positivity and risk factors in remote Australian Aboriginal communities.

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 other's 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.

Incidence of curable sexually transmissible infections among adolescents and young adults in remote Australian Aboriginal communities: analysis of longitudinal clinical service data.

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.

Point-of-care testing for chlamydia and gonorrhoea: implications for clinical practice.

OBJECTIVES: Point-of-care (POC) testing for chlamydia (CT) and gonorrhoea (NG) offers a new approach to the diagnosis and management of these sexually transmitted infections (STIs) in remote Australian communities and other similar settings. Diagnosis of STIs in remote communities is typically symptom driven, and for those who are asymptomatic, treatment is generally delayed until specimens can be transported to the reference laboratory, results returned and the patient recalled. The objective of this study was to explore the clinical implications of using CT/NG POC tests in routine clinical care in remote settings. METHODS: In-depth qualitative interviews were conducted with a purposively selected group of 18 key informants with a range of sexual health and laboratory expertise. RESULTS: Participants highlighted the potential impact POC testing would have on different stages of the current STI management pathway in remote Aboriginal communities and how the pathway would change. They identified implications for offering a POC test, specimen collection, conducting the POC test, syndromic management of STIs, pelvic inflammatory disease diagnosis and management, interpretation and delivery of POC results, provision of treatment, contact tracing, management of client flow and wait time, and re-testing at 3 months after infection. CONCLUSIONS: The introduction of POC testing to improve STI service delivery requires careful consideration of both its advantages and limitations. The findings of this study will inform protocols for the implementation of CT/NG POC testing, and also STI testing and management guidelines.