Distribution of rapid HCV antibody self-test kits via needle/syringe dispensing machines: Implementation and evaluation of the Vend-C pilot study in Melbourne, Australia.

Recent guidance from the World Health Organization strongly recommended hepatitis C virus (HCV) self-testing. We implemented the Vend-C pilot study to explore the effectiveness and feasibility of distributing rapid HCV antibody self-test kits to people who inject drugs via needle/syringe dispensing machines (SDMs). Over a 51-day study period between August and September 2022, we distributed HCV antibody self-test kits via two SDMs. During the study period, 63 self-test kits were dispensed, averaging 1.2 self-test kits per day. Our access methods for evaluation questionnaires failed to attract participants (n = 4). We implemented the Vend-C pilot study in direct response to recent WHO recommendations. While self-test kits were effectively distributed from the two SDMs, our evaluation methodology failed. Consequently, we cannot determine the success of linkage to care. Even so, with HCV treatment numbers dropping in Australia, innovative engagement solutions are needed, and considering the number of self-test kits provided in our pilot, the model could have an important future place in HCV elimination efforts.

Epidemiology and Management of invasive infections among people who Use drugs (EMU): protocol for a prospective, multicentre cohort study.

INTRODUCTION: People who inject drugs (PWID) are at risk of invasive infections such as bloodstream infections, endocarditis, osteomyelitis and septic arthritis. Such infections require prolonged antibiotic therapy, but there is limited evidence about the optimal care model to deliver to this population. The Epidemiology and Management of invasive infections among people who Use drugs (EMU) study aims to (1) describe the current burden, clinical spectrum, management and outcomes of invasive infections in PWID; (2) determine the impact of currently available models of care on completion of planned antimicrobials for PWID admitted to hospital with invasive infections and (3) determine postdischarge outcomes of PWID admitted with invasive infections at 30 and 90 days. METHODS AND ANALYSIS: EMU is a prospective multicentre cohort study of Australian public hospitals who provide care to PWIDs with invasive infections. All patients who have injected drugs in the previous six months and are admitted to a participating site for management of an invasive infection are eligible. EMU has two components: (1) EMU-Audit will collect information from medical records, including demographics, clinical presentation, management and outcomes; (2) EMU-Cohort will augment this with interviews at baseline, 30 and 90 days post-discharge, and data linkage examining readmission rates and mortality. The primary exposure is antimicrobial treatment modality, categorised as inpatient intravenous antimicrobials, outpatient antimicrobial therapy, early oral antibiotics or lipoglycopeptide. The primary outcome is confirmed completion of planned antimicrobials. We aim to recruit 146 participants over a 2-year period. ETHICS AND DISSEMINATION: EMU has been approved by the Alfred Hospital Human Research Ethics Committee (Project number 78815.) EMU-Audit will collect non-identifiable data with a waiver of consent. EMU-Cohort will collect identifiable data with informed consent. Findings will be presented at scientific conferences and disseminated by peer-review publications. TRIAL REGISTRATION NUMBER: ACTRN12622001173785; Pre-results.

Successful expanded clinic network collaboration and patient tracing for retention in HIV care.

BACKGROUND: There are more than 7,800 people living with human immunodeficiency virus (HIV) in Victoria, Australia. Crucial in maximising the individual and population level benefits from antiretroviral therapy (ART) is understanding how to achieve patient retention in care and the factors that drive it. This study was an expansion of a 2015 assessment of HIV-care retention in Victoria, which sought out to determine whether the inclusion of a broader range of HIV-healthcare sites would yield more accurate estimates of retention in HIV-care. We aimed to improve our understanding of HIV-care retention in Victoria, Australia, identify people living with HIV (PLHIV) with unknown outcomes, and attempt to re-engage PLHIV in care. METHODS: A network of 15 HIV-care sites was established in Victoria, Australia across diverse care settings which ranged from low-caseload rural sites to high-caseload metropolitan GP clinics and hospitals. Individuals who had an HIV viral load (VL) performed in both calendar years of 2016 and 2017 were classified as retained in care. Individuals with a VL test in 2016 but not in 2017 were considered to potentially have unknown outcomes as they may have been receiving care elsewhere, have disengaged from care or died. For this group, an intervention of cross-referencing partially de-identified data between healthcare sites, and contact tracing individuals who still had unknown outcomes was performed. RESULTS: For 5223 individuals considered to be retained in care across 15 healthcare sites in the study period, 49 had unconfirmed transfers of care to an alternative provider and 79 had unknown outcomes. After the intervention, the number of unconfirmed care transfers was reduced to 17 and unknown outcomes reduced to 51. These changes were largely attributed to people being reclassified as confirmed transfers of care. Retention in care estimates that did not include the patient outcome of confirmed transfer of care ranged from 76.2 to 95.8% and did not alter with the intervention. However, retention in care estimates which considered confirmed transfers and those that re-entered care at a new site as retained in care significantly increased across five of the sites with estimates ranging from 80.9 to 98.3% pre-intervention to 83.3-100% post-intervention. Individuals whose outcomes remained unknown post-intervention were more often men who have sex with men (MSM) when compared to other categories (person who injects drugs (PWID), combined PWID/MSM, men who identify as heterosexual or unknown) (74.5% vs. 53.5%, [p = 0.06]) and receiving ART at their last HIV-care visit (84.3% vs. 67.8% [p = 0.09]). CONCLUSION: This study confirmed high retention in HIV-care and low numbers of people disengaged from HIV-care in Victoria. This was demonstrated across a larger number of sites with varying models of care than a prior assessment in 2015. These data align with national and state targets aiming for 95% of PLHIV retained in HIV-care.

Favipiravir in early symptomatic COVID-19, a randomised placebo-controlled trial.

Background: Well tolerated antivirals administered early in the course of COVID-19 infection when the viremia is highest could prevent progression to severe disease. Favipiravir inhibits SARS-CoV-2 viral replication in vitro with evidence of clinical benefit in open label trials. Placebo controlled studies of people with early symptomatic COVID-19 with regular assessments of SARS-CoV-2 viral load can determine if it has an antiviral effect and improves clinical outcomes. Methods: People with PCR-confirmed COVID-19 and 5 days or less of symptoms were randomised 1:1 to favipiravir 1800 mg on day 1, then 800 mg twice daily or matched placebo for 14 days. SARS-CoV-2 viral load was quantitated from second daily self-collected nose-throat swabs while receiving study drug. The primary endpoint was time to virological cure defined as 2 successive swabs negative for SARS-CoV-2 by PCR and secondary outcomes were progression of disease severity, symptom resolution and safety. Findings: Between 31 July 2020 and 19 September 2021, 200 people were enrolled (199 in the community, 1 in hospital) with 190 receiving one or more doses of drug (modified intention to treat [mITT] population). There was no difference in time to virological cure (Log-rank p=0.6 comparing Kaplan Meier curves), progression to hospitalisation (14 favipiravir, 9 placebo; p=0.38), time to symptom resolution (cough, fever, sore throat) and there were no deaths. 51 people related an adverse event that was possibly drug related, but these were evenly distributed (n=24 favipiravir, n=27 placebo). Sensitivity analyses where the definition of virological cure was changed to: a single negative PCR, exclude datapoints based on the presence or absence of human DNA in the swab, a SARS-CoV-2 viral load < 300 copies/mL being considered negative all demonstrated no difference between arms. Interpretation: Favipiravir does not improve the time to virological cure or clinical outcomes and shows no evidence of an antiviral effect when treating early symptomatic COVID-19 infection. Funding: The study was supported in part by grants from the Commonwealth Bank Australia, the Lord Mayor's Charitable Foundation, Melbourne Australia and the Orloff Family Charitable Trust, Melbourne, Australia. JHM is supported by the Medical Research Future Fund, AYP, JT are supported by the Australian National Health and Medical Research Council.

Barriers to hepatitis C treatment among secondary needle and syringe program clients and opportunities to intervene.

BACKGROUND: At least 160,000 Australians are living with hepatitis C (HCV), many of whom are people who inject drugs and access needle and syringe programs (NSP). Secondary NSPs provide injecting equipment via health services that are not dedicated to the provision of services to people who inject drugs; these sites could be a suitable space to increase engagement of people who inject drugs in HCV treatment. Drawing on data from a pilot study exploring the potential of upscaling linkage to HCV care in secondary NSPs, the aim of this research was to explore barriers and enablers to HCV treatment for clients who use these services. METHODS: We interviewed 34 people who inject drugs (who self-reported HCV positivity) from six secondary NSPs in urban and regional Victoria, Australia in 2018. Fifty per cent were male, with ages ranging from 33 to 58. Twenty-two (65%) had never received HCV treatment and none had experience with direct-acting antiviral (DAA) treatment. Interviews were transcribed and analysed thematically. Field notes from a program evaluation with feedback from secondary NSP staff was also used as a secondary data source. RESULTS: Five themes encompassing a set of contrasting barriers and enablers to accessing HCV care through secondary NSPs were uncovered. Themes included 'misinformation' vs. 'multiple trusted information sources; 'lack of symptoms and motivation' vs. 'benefits of cure'; 'competing priorities' vs. 'willingness and readiness to be cured'; 'unsupportive relationships with staff' vs. 'supportive relationships with staff'; and 'inaccessibility and stigma in health services' vs. 'enhanced support'. Secondary program evaluation data also highlighted that secondary NSP staff were under-resourced and had limited capacity to implement HCV care linkage and information. CONCLUSION: We identified contrasting barriers and opportunities for accessing DAAs among a sample of secondary NSP clients and staff. Interventions that consider individual, provider and health system level factors are needed if secondary NSP services are to become a suitable setting to initiate conversations with clients around HCV treatment and provide linkages to care.

Surveillance of life-long antibiotics-A cross-sectional cohort study assessing patient attitudes and understanding of long-term antibiotic consumption.

BACKGROUND: Some patients receive long-term or life-long antibiotics for suppression of infections deemed otherwise incurable. Little is known about the consequences of this strategy. We aimed to explore patients' attitudes towards and knowledge concerning prolonged antibiotic therapy. METHODS: A cross-sectional cohort pilot study of outpatients on long-term antibiotics was performed. Surveys were conducted at our healthcare network in Victoria, Australia between April and December 2015. Microbiological screening for multi-resistant organisms (MRO) was also performed. RESULTS: Heterogeneity was noted in the prescribed antibiotics and documented indications, with rifampicin and fusidic acid for suppression of prosthetic joint infection the most common regimen and indication. 41% (12/29) of participants reported side-effects attributed to their antibiotics, but 72% (21/29) still declared complete adherence to their prescribed regimen. 76% (22/29) of participants stated that they would cease their long-term antibiotics based on medical advice. 19/29 (66%) participants consented to microbiological screening and 4 were found to be colonised with MROs. They had spent more days as an inpatient in the preceding 12 months than the screened participants who were not colonised. CONCLUSION: Participants in this study had a good understanding of their infection and the indications for their long-term antibiotic therapy, and were adherent to this therapy despite many experiencing side-effects attributed to their antibiotics. Patients who are prescribed life-long antibiotics can be carriers of multi-resistant organisms, but both the drivers of this resistance, and the broader impact of colonisation with MRO in this population is unclear.