Clinical effectiveness and analytical quality of a national point-of-care testing network for sexually transmitted infections integrated into rural and remote primary care clinics in Australia, 2016-2022: an observational program evaluation.

Background: To address inequitable diagnostic access and improve time-to-treatment for First Nations peoples, molecular point-of-care (POC) testing for chlamydia, gonorrhoea and trichomonas was integrated into 49 primary care clinics across Australia. We conducted an observational evaluation to determine clinical effectiveness and analytical quality of POC testing delivered through this national program. Methods: We evaluated (i) implementation by measuring trends in mean monthly POC testing; ii) clinical effectiveness by comparing proportions of positive patients treated by historical control/intervention period and by test type, and calculated infectious days averted; (iii) analytical quality by calculating result concordance by test type, and proportion of unsuccessful POC tests. Findings: Between 2016 and 2022, 46,153 POC tests were performed; an increasing mean monthly testing trend was observed in the first four years (p < 0.0001). A greater proportion of chlamydia/gonorrhoea positives were treated in intervention compared with historical control periods (≤2 days: 37% vs 22% [RR 1.68; 95% CI 1.12, 2.53]; ≤7 days: 48% vs 30% [RR 1.6; 95% CI 1.10, 2.33]; ≤120 days: 79% vs 54% [RR 1.46; 95% CI 1.10, 1.95]); similarly for trichomonas positives and by test type. POC testing for chlamydia, gonorrhoea and trichomonas averted 4930, 5620 and 7075 infectious days, respectively. Results concordance was high [99.0% (chlamydia), 99.3% (gonorrhoea) and 98.9% (trichomonas)]; unsuccessful POC test proportion was 1.8% for chlamydia/gonorrhoea and 2.1% for trichomonas. Interpretation: Molecular POC testing was successfully integrated into primary care settings as part of a routinely implemented program achieving significant clinical benefits with high analytical quality. In addition to the individual health benefits of earlier treatment, fewer infective days could contribute to reduced transmissions in First Nations communities. Funding: This work was supported by an Australian National Health and Medical Research Council Partnership Grant (APP1092503), the Australian Government Department of Health, Western Australia and Queensland Departments of Health.

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.

Challenges to integrating programs for the elimination of mother-to-child transmission of HIV, syphilis, and hepatitis B into antenatal care: Experiences from Indonesia.

The WHO's Asia-Pacific framework for triple elimination recommends that countries evaluate their programs for the elimination of mother-to-child transmission of HIV, syphilis, and hepatitis B (EMTCT), including identifying gaps to improve program planning and the implementation of elimination strategies in antenatal care (ANC) services. In 2022, the Indonesian Ministry of Health reported that only 39% of pregnant women were tested for HIV, 14% for syphilis, and 28% for hepatitis B, respectively. We conducted a qualitative study involving a focus group discussion (FGD) and in-depth interviews with 25 key stakeholders in Bali and West Nusa Tenggara Provinces to identify specific challenges to testing for HIV, syphilis, and hepatitis B in ANC settings. Thematic analysis was used to identify the themes generated from the data. Health system bottlenecks experienced by stakeholders included supply chain management issues involving stock forecasting and stock monitoring, stock-outs of rapid test reagents which were particularly most frequent and for longer durations for syphilis and hepatitis B, high staff turnover, lack of staff training on how to perform the test, the complexity and time needed to record the data on women's characteristics, risk behaviours, and testing in both paper format and into the computer-based surveillance systems, discrepancies in program coverage data from different divisions of the district health office involved in the reporting system, high levels of stigma that prevented women from being followed up, challenges in notifying partners, and inadequate reporting and referral of women from private providers to public ones for testing. Interventions addressing the above challenges are worthy of consideration to improve the health system function and integrate EMTCT into the ANC settings.

Testing, diagnosis, and treatment following the implementation of a program to provide dried blood spot testing for HIV and hepatitis C infections: the NSW DBS Pilot.

BACKGROUND: Dried blood spot (DBS) testing provides an alternative to phlebotomy and addresses barriers to accessing healthcare experienced by some key populations. Large-scale evaluations of DBS testing programs are needed to understand their feasibility. This study evaluated the implementation of a state-wide DBS HIV and hepatitis C virus (HCV) testing pilot. METHODS: The New South Wales (NSW) DBS Pilot is an interventional cohort study of people testing for HIV antibody and/or HCV RNA from DBS samples in NSW, Australia. Participants at risk of HIV/HCV participated in testing via: 1) self-registration online with a DBS collection kit delivered and returned by conventional postal service; or 2) assisted DBS sample collection at 36 community health sites (including drug treatment and harm-minimisation services) and prisons. Participants received results by text (HIV antibody/ HCV RNA not detected) or a healthcare provider (HIV antibody/ HCV RNA detected). The RE-AIM framework was used to evaluate reach, effectiveness, adoption, and implementation. RESULTS: Reach: Between November 2016 and December 2020, 7,392 individuals were tested for HIV and/or HCV (21% self-registration, 34% assisted in community, and 45% assisted in prison). EFFECTIVENESS: Of 6,922 people tested for HIV (19% men who have sex with men, 13% living outside major cities, 21% born outside Australia), 51% (3,521/6,922) had no HIV test in the past two years, 0.1% (10/6,922) were newly diagnosed with HIV, and 80% (8/10) initiated HIV treatment within six months. Of 5,960 people tested for HCV (24% women, 35% Aboriginal and/or Torres Strait Islander, 55% recently injected drugs), 15% had detectable HCV RNA (878/5,960), and 45% (393/878) initiated treatment within six months. Adoption: By the end of 2020, DBS via assisted registration was available at 36 community sites and 21 prisons. IMPLEMENTATION: 90% of DBS cards arriving at the laboratory had the three full spots required for testing; the proportion was higher in assisted (94%) compared to online (76%) registration. CONCLUSIONS: This study demonstrated the feasibility of DBS testing for HIV and HCV in key populations including Aboriginal and Torres Strait Islander peoples, men who have sex with men, people who inject drugs, and demonstrated the utility of DBS in the prison setting.

We have reached single-visit testing, diagnosis, and treatment for hepatitis C infection, now what?

INTRODUCTION: Progress toward hepatitis C virus (HCV) elimination is impeded by low testing and treatment due to the current diagnostic pathway requiring multiple visits leading to loss to follow-up. Point-of-care testing technologies capable of detecting current HCV infection in one hour are a 'game-changer.' These tests enable diagnosis and treatment in a single visit, overcoming the barrier of multiple visits that frequently leads to loss to follow-up. Combining point-of-care HCV antibody and RNA tests should improve cost-effectiveness, patient/provider acceptability, and testing efficiency. However, implementing HCV point-of-care testing programs at scale requires multiple considerations. AREAS COVERED: This commentary explores the need for point-of-care HCV tests, diagnostic strategies to improve HCV testing, key considerations for implementing point-of-care HCV testing programs, and remaining challenges for point-of-care testing (including operator training, quality management, connectivity and reporting systems, regulatory approval processes, and the need for more efficient tests). EXPERT OPINION: It is exciting that single-visit testing, diagnosis, and treatment for HCV infection have been achieved. Innovations afforded through COVID-19 should facilitate the accelerated development of low-cost, rapid, and accurate tests to improve HCV testing. The next challenge will be to address barriers and facilitators for implementing point-of-care testing to deliver them at scale.

Flexible and Innovative Connectivity Solution to Support National Decentralized Infectious Diseases Point-of-Care Testing Programs in Primary Health Services: Descriptive Evaluation Study.

BACKGROUND: Molecular point-of-care (POC) testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) has been available in regional and remote primary health services in Australia as part of a decentralized POC testing program since 2016 and for SARS-CoV-2 from 2020. As there was no suitable existing connectivity infrastructure to capture and deliver POC test results to a range of end users, a new system needed to be established. OBJECTIVE: The aim of the study is to design, implement, and optimize a connectivity system to meet clinical management, analytical quality management, and public health surveillance needs. METHODS: We used commercially available e-messaging technology coupled with adapted proprietary software to integrate a decentralized molecular POC testing platform (GeneXpert) in primary health services and interface with end-user databases. This connectivity infrastructure was designed to overcome key barriers to the implementation, integration, and monitoring of these large multijurisdictional infectious disease POC testing networks. Test result messages were tailored to meet end-user needs. Using centrally captured deidentified data, we evaluated the time to receipt of test results and completeness of accompanying demographic data. RESULTS: From January 2016 to April 2020, we operationalized the system at 31 health services across 4 jurisdictions and integrated with 5 different patient management systems to support the real-time delivery of 29,356 CT/NG and TV test results to designated recipients (patient management system and local clinical and central program databases). In 2019, 12,105 CT/NG and TV results were delivered, and the median time to receipt of results was 3.2 (IQR 2.2-4.6) hours, inclusive of test runtime. From May 2020 to August 2022, we optimized the system to support rapid scale-up of SARS-CoV-2 testing (105 services; 6 jurisdictions; 71,823 tests) and additional sexually transmissible infection testing (16,232 tests), including the electronic disease-specific notifications to jurisdictional health departments and alerts for connectivity disruption and positive results. In 2022, 19,355 results were delivered with an overall median transmission time of 2.3 (IQR 1.4-3.1) hours, 2.2 (IQR 1.2-2.3) hours for SARS-CoV-2 (n=16,066), 3.0 (IQR 2.0-4.0) hours for CT/NG (n=1843), and 2.6 (IQR 1.5-3.8) hours for TV (n=1446). Demographic data (age, sex, and ethnicity) were completed for 99.5% of test results in 2022. CONCLUSIONS: This innovative connectivity system designed to meet end-user needs has proven to be sustainable, flexible, and scalable. It represents the first such system in Australia established independent of traditional pathology providers to support POC testing in geographically dispersed remote primary health services. The system has been optimized to deliver real-time test results and has proven critical for clinical, public health, and quality management. The system has significantly supported equitable access to rapid diagnostics for infectious diseases across Australia, and its design is suitable for onboarding other POC tests and testing platforms in the future.

Left ventricular remodelling in rheumatic heart disease - trends over time and implications for follow-up in childhood.

BACKGROUND: Rheumatic heart disease (RHD) is the most common form of acquired heart disease worldwide. In RHD, volume loading from mitral regurgitation leads to left ventricular (LV) dilatation, increased wall stress, and ultimately LV dysfunction. Improved understanding of LV dynamics may contribute to refined timing of intervention. We aimed to characterize and compare left ventricular remodelling between rheumatic heart disease (RHD) severity groups by way of serial echocardiographic assessment of volumes and function in children. METHODS: Children with RHD referred to Perth Children's Hospital (formally Princess Margaret Hospital) (1987-2020) were reviewed. Patients with longitudinal pre-operative echocardiograms at diagnosis, approximately 12 months and at most recent follow-up, were included and stratified into RHD severity groups. Left ventricular (LV) echocardiographic parameters were assessed. Adjusted linear mixed effect models were used to compare interval changes. RESULTS: 146 patients (median age 10 years, IQR 6-14 years) with available longitudinal echocardiograms were analysed. Eighty-five (58.2%) patients had mild, 33 (22.6%) moderate and 28 (19.2%) severe RHD at diagnosis. Mean duration of follow-up was 4.6 years from the initial diagnosis. Severe RHD patients had significantly increased end-systolic volumes (ESV) and end-diastolic volumes (EDV) compared to mild/moderate groups at diagnosis (severe versus mild EDV mean difference 27.05 ml/m2, p < 0.001, severe versus moderate EDV mean difference 14.95 ml/m2, p = 0.006). Mild and moderate groups experienced no significant progression of changes in volume measures. In severe RHD, LV dilatation worsened over time. All groups had preserved cardiac function. CONCLUSIONS: In mild and moderate RHD, the lack of progression of valvular regurgitation and ventricular dimensions suggest a stable longer-term course. Significant LV remodelling occurred at baseline in severe RHD with progression of LV dilatation over time. LV function was preserved across all groups. Our findings may guide clinicians in deciding the frequency and timing of follow-up and may be of clinical utility during further reiterations of the Australia and New Zealand RHD Guidelines.

Impact of mitral regurgitation on left ventricular remodeling and function in children with rheumatic heart disease.

The impact of mitral regurgitation (MR) from pediatric rheumatic heart disease (RHD) and its effect on left ventricular (LV) remodeling and function following surgical intervention is uncertain. The objective is to explore the impact of mitral valve (MV) surgeries on myocardial mechanics, remodeling and function and identify pre-operative predictors of post-operative dysfunction which may contribute to the optimal timing of intervention. A retrospective review of echocardiographic data was performed of eighteen pediatric patients with RHD (median 9yrs, IQR 6-12) who underwent MV surgery. Echocardiograms pre-operatively and a median of 13.5 months (IQR 10.2-15) following intervention were compared to controls. Pre-operative LV end-diastolic indexed volumes (LVEDVi) were significantly increased compared to controls and remained persistently larger post-operatively. LV ejection fraction (LVEF) (pre 62.6% ± 6.1, post 51.7% ± 9.7, p = 0.002), and global longitudinal strain (GLS) (pre - 24.3 ± 4.1, post - 18.2 ± 2.6, p < 0.001) decreased post-operatively at mid-term follow-up. Pre-operative LVEDVi was a significant predictor of post-operative LVEF, with a cut-off of ≥ 102 ml/m2 associated with LV dysfunction (LVEF < 55%; sensitivity 70%, specificity 75%). Pre-operative LVEDVi also negatively correlated with GLS (r = - 0.58, p = 0.01). LV dimensions and volumes remain persistently larger than controls while LV function decreases post-surgical alleviation of MR in paediatric RHD. Pre-operative LVEDVi predicted post-operative LV dysfunction and utilising LV indexed volumes in directing timing of surgical planning should be considered. Further studies are required to investigate whether timely alleviation of MR before significant LV dilatation and remodeling occur may substantially prevent LV dysfunction and improve outcomes.

Incidence and risk factors for syphilis infection among men who have sex with men: A cohort study from an urban sexual health clinic in Jakarta, Indonesia.

Objective: Syphilis infection remains a significant health issue among marginalised populations in Indonesia, in particular among men who have sex with men (MSM), in whom there are limited studies from Indonesia exploring risk factors associated with STI acquisition.Our study aimed to identify risk factors of syphilis infection among MSM attending large sexual health clinic in Jakarta. Methods: We conducted a retrospective cohort analysis using patient records (MSM aged 18 years or older) period Jan 2018-Dec 2019. We used Cox regression to identify risk factors associated with syphilis incidence. Results: Study population were 2912 MSM tested for syphilis, 473 (16.2%) were diagnosed with syphilis on their first visit; early syphilis (415; 14%) and latent syphilis (58, 2%). Among the cohort of 2439 MSM who tested negative at baseline, 40 MSM were identified with a new positive syphilis result during 2 years follow up. Risk factors remaining significantly associated with syphilis incidence included having STI symptom at 1st visit (aHR, 2.8; 95% CI, 1.38-5.65), and HIV-infection (aHR 4.53; 95% CI 2.24 - 9.17).Syphilis incidence rate was 8.19 (95% CI 6.01-11.16) per 100 PYFU. Conclusions: Syphilis infection at baseline and incidence was high among MSM attending this large clinic in Jakarta. Integrated and accessible syphilis prevention and detection coupled with HIV services are needed, with a special focus on high-risk individuals.

A Double-blinded, Randomized, Placebo-controlled Trial of Antibiotic Prophylaxis in Elective Non-hysterectomy Laparoscopic Surgery for Benign Gynecologic Conditions: A Pilot Study.

STUDY OBJECTIVE: To determine the feasibility of a double-blinded randomized, placebo-controlled study in determining the efficacy of antibiotic prophylaxis in preventing postoperative infections (POIs) in elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions. DESIGN: Double-blinded, randomized, placebo-controlled trial. SETTING: University-affiliated tertiary referral hospital in Sydney, Australia. PATIENTS: Women older than 18 years undergoing elective nonhysterectomy laparoscopic procedures for benign gynecologic conditions were eligible for the study and approached. INTERVENTIONS: Before surgery, participants were randomized to receive either 2-g cephazolin or placebo (10-mL normal saline) administered by the anesthetist. Participants and other research staff were blinded to group allocation. MEASUREMENTS AND MAIN RESULTS: The primary outcome was study feasibility measured by recruitment rates, compliance rates of drug administration, compliance rates of delivery, maintenance of double blinding, and follow-up rates. Secondary outcomes included rate of POIs, length of hospitalization, readmission to hospital, unscheduled presentations to healthcare facilities, and antibiotic-related reactions. Between February 2019 and March 2021, 170 patients were approached with 117 participants (68.8%) recruited and randomized. The study had a high compliance rate of trial drug delivery (95.7%) and a high follow-up rate (99.1%). CONCLUSION: This pilot study has demonstrated feasibility of a large-scale study with a recruitment rate of 68% of patients approached and excellent trial drug delivery and follow-up rates. As anticipated, it is underpowered for identifying clinically significant findings for POI rates. A large-scale study is appropriate and essential to determine the health-related risks of antibiotic prophylaxis with an emphasis on antimicrobial stewardship. The sample size for a large-scale study is 1678 participants based on infection rates in this pilot study.

Hospitalisations for pelvic inflammatory disease in young Aboriginal women living in remote Australia: the role of chlamydia and gonorrhoea.

OBJECTIVE: Aboriginal 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. METHODS: Using 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. RESULTS: The 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%). CONCLUSION: Our 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.

Scaling up sexually transmissible infections point-of-care testing in remote Aboriginal and Torres Strait Islander communities: healthcare workers' perceptions of the barriers and facilitators.

BACKGROUND: Sexually transmissible infections (STIs), such as gonorrhoea and chlamydia, are highly prevalent, particularly in remote Aboriginal and Torres Strait Islander communities in Australia. In these settings, due to distance to centralised laboratories, the return of laboratory test results can take a week or longer, and many young people do not receive treatment, or it is considerably delayed. Point-of-care testing (POCT) provides an opportunity for same day diagnosis and treatment. Molecular POC testing for STIs was available at 31 regional or remote primary health care clinic sites through the Test-Treat-And-GO (TANGO2) program. This qualitative study sought to identify barriers and facilitators to further scaling up STI POCT in remote Aboriginal communities within Australia. METHODS: A total of 15 healthcare workers (including nurses and Aboriginal health practitioners) and five managers (including clinic coordinators and practice managers) were recruited from remote health services involved in the TTANGO2 program to participate in semi-structured in-depth interviews. Health services' clinics were purposively selected to include those with high or low STI POCT uptake. Personnel participants were selected via a hybrid approach including nomination by clinic managers and purposive sampling to include those in roles relevant to STI testing and treatment and those who had received TTANGO2 training for POCT technology. Milat's scaling up guide informed the coding framework and analysis. RESULTS: Acceptability of STI POCT technology among healthcare workers and managers was predominantly influenced by self-efficacy and perceived effectiveness of POCT technology as well as perceptions of additional workload burden associated with POCT. Barriers to integration of STI POCT included retention of trained staff to conduct POCT. Patient reach (including strategies for patient engagement) was broadly considered an enabler for STI testing scale up using POCT technology. CONCLUSIONS: Remote healthcare clinics should be supported by both program and clinic management throughout scaling up efforts to ensure broad acceptability of STI POCT as well as addressing local health systems' issues and identifying and enhancing opportunities for patient engagement.

COVID-19 in health care workers, Australia 2020.

BACKGROUND: Health care workers are at increased risk of SARS-CoV-2 infection due to potential exposure to patients or staff in health care settings. Australian health care services and health care workers experienced intense pressure to prepare for and respond to SARS-CoV-2 infections. We summarise national data on health care worker infections and associated outbreaks during 2020. METHODS: We collected aggregated data on infected health care workers and outbreaks in health care facilities from all jurisdictions. Health care workers working solely in residential aged care and outbreaks in residential aged care facilities were excluded. Jurisdictions provided data on the number of health care setting outbreaks, confirmed cases, hospitalisation, source of infection, and health care worker role. We analysed data for two periods that aligned with two distinct peaks in the epidemic relative to 1 June 2020, referred to here as the first wave (23 January - 31 May 2020) and the second wave (1 June - 18 September 2020). RESULTS: Jurisdictions reported a total of 2,163 health care worker infections with SARS-CoV-2 during the surveillance period. Source of acquisition was known for 81.0% of cases (1,667/2,059). The majority of cases in the first wave were acquired overseas, shifting to locally-acquired cases in the second wave. The odds of infection in the second wave compared to the first wave were higher for nurses/midwives (odds ratio, OR: 1.61; 95% confidence interval (95% CI): 1.32-2.00), lower for medical practitioners (OR: 0.36; 95% CI: 0.28-0.47) and did not differ for 'other' health care workers (OR: 1.07; 95% CI: 0. 87-1.32). The odds of infection in the second wave were higher in a health care setting (OR: 1.76; 95% CI: 1.28-2.41) than in the community. There were 120 outbreaks in health care settings with 1,428 cases, of which 56.7% (809/1,428) were health care workers. The majority (88/120; 73.8%) of outbreaks in health care settings occurred in the second wave of the epidemic, with 90.9% of these (80/88) occurring in Victoria. CONCLUSIONS: In the second wave of the epidemic, when there was heightened community transmission, health care workers were more likely to be infected in the workplace. Throughout the epidemic, nurses were more likely to be infected than staff in other roles.

Economic evaluation of point-of-care testing and treatment for sexually transmitted and genital infections in pregnancy in low- and middle-income countries: A systematic review.

BACKGROUND: Sexually transmitted and genital infections in pregnancy are associated with adverse pregnancy and birth outcomes. Point-of-care tests for these infections facilitate testing and treatment in a single antenatal clinic visit and may reduce the risk of adverse outcomes. Successful implementation and scale-up depends on understanding comparative effectiveness of such programmes and their comparative costs and cost effectiveness. This systematic review synthesises and appraises evidence from economic evaluations of point-of-care testing and treatment for sexually transmitted and genital infections among pregnant women in low- and middle-income countries. METHODS: Medline, Embase and Web of Science databases were comprehensively searched using pre-determined criteria. Additional literature was identified by searching Google Scholar and the bibliographies of all included studies. Economic evaluations were eligible if they were set in low- and middle-income countries and assessed antenatal point-of-care testing and treatment for syphilis, chlamydia, gonorrhoea, trichomoniasis, and/or bacterial vaginosis. Studies were analysed using narrative synthesis. Methodological and reporting standards were assessed using two published checklists. RESULTS: Sixteen economic evaluations were included in this review; ten based in Africa, three in Latin and South America and three were cross-continent comparisons. Fifteen studies assessed point-of-care testing and treatment for syphilis, while one evaluated chlamydia. Key drivers of cost and cost-effectiveness included disease prevalence; test, treatment, and staff costs; test sensitivity and specificity; and screening and treatment coverage. All studies met 75% or more of the criteria of the Drummond Checklist and 60% of the Consolidated Health Economics Evaluation Reporting Standards. CONCLUSIONS: Generally, point-of-care testing and treatment was cost-effective compared to no screening, syndromic management, and laboratory-based testing. Future economic evaluations should consider other common infections, and their lifetime impact on mothers and babies. Complementary affordability and equity analyses would strengthen the case for greater investment in antenatal point-of-care testing and treatment for sexually transmitted and genital infections.

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.

'If you can't make it, you're not tough enough to do medicine': a qualitative study of Sydney-based medical students' experiences of bullying and harassment in clinical settings.

BACKGROUND: Media exposés and academic literature reveal high rates of bullying and harassment of medical students, most commonly by consultant physicians and/or surgeons. Recent reports reveal the medical profession to be characterised by hierarchy, with verbal abuse a 'rite of passage', as well as sexist and racist behaviours. METHODS: Semi-structured in-depth interviews were conducted with ten current or recently graduated medical students from Sydney-based medical schools. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. RESULTS: Hierarchy, and a culture of self-sacrifice, resilience and deference, were identified as problematic elements of the medical profession. In the minds of participants, these factors created barriers to reporting mistreatment, as participants felt reporting led to being labelled a 'troublemaker', affecting career progression. Additionally, participants stated that avenues of recourse were unclear and did not guarantee confidentiality or desired outcomes. CONCLUSIONS: Mistreatment is continuing in clinical teaching and has negative consequences on medical students' mental health and learning. Structural change is needed to combat institutionalised mistreatment to ensure the wellbeing of future doctors and high quality patient care.

Cost and cost-effectiveness of point-of-care testing and treatment for sexually transmitted and genital infections in pregnancy in low-income and middle-income countries: a systematic review protocol.

INTRODUCTION: The economic and health burden of sexually transmitted and genital infections (henceforth, STIs) in low-income and middle-income countries (LMICs) is substantial. Left untreated, STIs during pregnancy may result in several adverse pregnancy and birth outcomes. Timely diagnosis and treatment at point-of-care (POC) can potentially improve these outcomes. Despite the availability and promotion of POC diagnostics for STIs as a key component of antenatal care in LMICs, their widespread use has been limited, owing to the high economic costs faced by individuals and health systems. To date, there have been no systematic reviews which explore the cost or cost-effectiveness of POC testing and treatment of STIs in pregnancy in LMICs. The objective of this protocol is to outline the methods that will compare, synthesise and appraise the existing literature in this domain. METHODS AND ANALYSIS: We will conduct literature searches in MEDLINE, Embase and Web of Science. To find additional literature, we will search Google Scholar and hand search reference lists of included papers. Two reviewers will independently search databases, screen titles, abstracts and full texts; when necessary a third reviewer will resolve disputes. Only cost and cost-effectiveness studies of POC testing and treatment of STIs, including syphilis, chlamydia, trichomonas, gonorrhoea and bacterial vaginosis, in pregnancy in LMICs will be included. Published checklists will be used to assess quality of reporting practices and methodological approaches. We will also assess risk of publication bias. Interstudy heterogeneity will be assessed and depending on variation between studies, a meta-analysis or narrative synthesis will be conducted. ETHICS AND DISSEMINATION: Ethical approval is not required as the review will use published literature. The results will be published in a peer-reviewed open source journal and presented at an international conference. PROSPERO REGISTRATION NUMBER: CRD42018109072.

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.