Belinda Hengel

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 others 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.

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.

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.

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.

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.

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.

O22.6 Field Evaluation of Three Point-Of-Care Tests For Chlamydia and Gonorrhoea in Remote Health Services in Australia

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.

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.

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.