Protocol for an HIV Pre-exposure Prophylaxis (PrEP) Population Level Intervention Study in Victoria Australia: The PrEPX Study.

Background: Pre-exposure prophylaxis (PrEP) is the use of HIV anti-retroviral therapy to prevent HIV transmission in people at high risk of HIV acquisition. PrEP is highly efficacious when taken either daily, or in an on-demand schedule. In Australia co-formulated tenofovir-emtricitabine is registered for daily use for PrEP, however, this co-formulation is not listed yet on the national subsidized medicines list. We describe a study protocol that aims to demonstrate if the provision of PrEP to up to 3800 individuals at risk of HIV in Victoria, Australia reduces HIV incidence locally by 25% generally and 30% among GBM. Methods: PrEPX is a population level intervention study in Victoria, Australia in which generic PrEP will be delivered to 3800 individuals for up to 36 months. Study eligibility is consistent with the recently updated 2017 Australian PrEP guidelines. Participants will attend study clinics, shared care clinics, or outreach clinics for quarterly HIV/STI screening, biannual renal function tests and other clinical care as required. Study visits and STI diagnoses will be recorded electronically through the ACCESS surveillance system. At each study visit participants will be invited to complete behavioral surveys that collect demographics and sexual risk data. Diagnosis and behavioral data will be compared between PrEPX participants and other individuals testing within the ACCESS surveillance system. A subset of participants will complete in depth surveys and interviews to collect attitudes, beliefs and acceptability data. Participating clinics will provide clinic level data on implementation and management of PrEPX participants. The population level impact on HIV incidence will be assessed using Victorian HIV notification data. Discussion: This study will collect evidence on the real world impact of delivery of PrEP to 3800 individuals at risk of acquiring HIV in Victoria. This study will provide important information for the broader implementation of PrEP planning upon listing of the tenofovir-emtricitabine on the national subsidized list of medicines. The study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12616001215415).

'Beyond the willing & the waiting' - The role of peer-based approaches in hepatitis C diagnosis & treatment.

This commentary seeks to examine the role, value and importance of peer-based programmatic approaches for ensuring the effective roll-out of the new hepatitis C (HCV) treatments among those most affected - that is, people who inject drugs (PWID). The authors examine recent approaches to HCV treatment in Australia including the provision of universal access to the new DAA regimens regardless of acquisition, genotype or severity of disease. These approaches are contextualised within wider global strategies to support HCV elimination as a public health threat by 2030 (WHO, 2016). Despite the unprecedented opportunity presented by the availability of the new treatments, the fact remains that those most affected by hepatitis C are still largely hidden and disconnected from the health system and are likely to stay that way without targeted education and support. There is a need to for greater investment in new and innovative HCV+ PWID peer education approaches for HCV diagnosis and treatment that add value to existing models of care to improve pathways and support people across their entire treatment journey. Key components include expanding existing peer-based programmes and developing new innovative peer initiatives, supporting the development of the PWID peer workforce, developing new, targeted peer education resources and promoting linkages and partnerships between peer based and HCV treatment service providers in primary and community settings. Our approach to HCV elimination needs to take account of people's broader lives, their vulnerabilities, their life journeys and their potential points of connection, engagement and access. Peer-based organisations and networks provide that unique point of engagement and access for those HCV+ PWID for whom the health system is an unfamiliar even forbidding place or for whom hepatitis C can be but one of many overwhelming issues in the lives.

The acceptability and feasibility of peer worker support role in community based HCV treatment for injecting drug users.

Hepatitis C is the most common blood borne virus in Australia affecting over 200 000 people. Effective treatment for hepatitis C has only become accessible in Australia since the late 1990's, although active injecting drug use (IDU) remained an exclusion criteria for government-funded treatment until 2001. Treatment uptake has been slow, particularly among injecting drug users, the largest affected group. We developed a peer-based integrated model of hepatitis C care at a community drug and alcohol clinic. Clients interested and eligible for hepatitis C treatment had their substance use, mental health and other psychosocial comorbidities co-managed onsite at the clinic prior to and during treatment. In a qualitative preliminary evaluation of the project, nine current patients of the clinic were interviewed, as was the clinic peer worker. A high level of patient acceptability of the peer-based model and an endorsement the integrated model of care was found. This paper describes the acceptability of a peer-based integrated model of hepatitis C care by the clients using the service.

Molecular epidemiology of hepatitis C virus in a social network of injection drug users.

BACKGROUND: We aimed to measure the overlap between the social networks of injection drug users (IDUs) and the patterns of related hepatitis C virus (HCV) infections among IDUs. METHODS: A cohort of 199 IDUs (138 of whom were HCV RNA positive) was recruited from a local drug scene in Melbourne, Australia, and was studied using social network analysis and molecular phylogenetic analysis of 2 regions of the HCV genome. RESULTS: Eighteen clusters of related infections involving 51 IDUs (37.0% of HCV RNA-positive IDUs) were detected; these clusters could be separated into 66 discrete pairs. Twelve (18.2%) of the 66 IDU pairs with related infections reported having previously injected drugs together; conversely, only 12 (3.8%) of the 313 pairs of HCV RNA-positive IDUs who were injection partners had strong molecular evidence of related infections. The social and genetic distances that separated IDUs with identical genotypes were weakly associated. Significant clusters of phylogenetically related sequences identified from core region analysis persisted in the analysis of the nonstructural 5a protein region. Genotyping and sequence analysis revealed 2 mixed-genotype infections. CONCLUSIONS: Static social network methods are likely to gather information about a minority of patterns of HCV transmission, because of the difficulty of determining historical infection pathways in an established social network of IDUs. Nevertheless, molecular epidemiological methods identified clusters of IDUs with related viruses and provided information about mixed-genotype infection status.