Pre-exposure prophylaxis (PrEP) for HIV prevention among people who inject drugs: a global mapping of service delivery.

BACKGROUND: The World Health Organization (WHO) recommends oral pre-exposure prophylaxis (PrEP) for all people at substantial risk of HIV as part of combination prevention. The extent to which this recommendation has been implemented globally for people who inject drugs is unclear. This study mapped global service delivery of PrEP for people who inject drugs. METHODS: Between October and December 2021, a desk review was conducted to obtain information on PrEP services for people who inject drugs from drug user-led networks and HIV, harm reduction, and human rights stakeholders. Websites of organizations involved in HIV prevention or services for people who inject drugs were searched. Models of service delivery were described in terms of service location, provider, and package. RESULTS: PrEP services were identified in 27 countries (15 high-income). PrEP delivery models varied within and across countries. In most services, PrEP services were implemented in healthcare clinics without direct links to other harm reduction services. In three countries, PrEP services were also provided at methadone clinics. In 14 countries, PrEP services were provided through community-based models (outside of clinic settings) that commonly involved peer-led outreach activities and integration with harm reduction services. CONCLUSIONS: This study indicates limited PrEP availability for people who inject drugs. There is potential to expand PrEP services for people who inject drugs within harm reduction programs, notably through community-based and peer-led services. PrEP should never be offered instead of evidence-based harm reduction programs for people who inject drugs; however, it could be offered as an additional HIV prevention choice as part of a comprehensive harm reduction program.

A gender lens is needed in hepatitis C elimination research.

The World Health Organisation has established a goal of eliminating the hepatitis C virus (HCV) as a public health threat by 2030. Considerable effort is being directed towards research to support and enhance HCV treatment uptake among people who inject drugs, but there is a distinct lack of attention given to gender in this work. We argue that a gender lens is needed to make visible the limitations of current HCV elimination research, and support the development of innovative, inclusive approaches to HCV treatment. Partnerships between researchers and people who inject drugs are essential in this work, particularly in the development and evaluation of programs by and for women who inject drugs. Failure to acknowledge the gendered dimensions of HCV elimination risks entrenching gender disparities in access to treatment and cure.

Basic care as exceptional care: addiction stigma and consumer accounts of quality healthcare in Australia.

The discrimination faced by people understood to have alcohol or other drug addictions has been the subject of extensive research, with many studies documenting experiences of stigma within healthcare services. Building on this literature, we examine the role of stigma in shaping the healthcare expectations of people seen as affected by alcohol and other drug addictions. Our analysis draws on recent theorisations of stigma as a process of social production to analyse in-depth, qualitative interviews with 20 people who had recently attended an inpatient withdrawal management service. Participants describe as exceptional forms of care that are often taken for granted by other members of the community. We argue that routinised experiences of discrimination work to constitute basic care as exceptional. This finding is significant for two reasons: (1) people who consume alcohol and other drugs often have complex healthcare needs and already encounter obstacles to accessing the care they need, and (2) by positioning people who consume drugs outside the purview of healthcare, this dynamic obstructs their fundamental right to care. We conclude by reflecting on the implications of these findings for those who are often positioned as not entitled to high quality healthcare.

Making legitimacy: Drug user representation in United Nations drug policy settings.

BACKGROUND: The importance of engaging people who use drugs in drug policy development is increasingly acknowledged including in recent UN documents. Little scholarly attention has been paid to 'drug user representation' in the global drug policy setting of the UN such as the Commission on Narcotic Drugs (CND). This paper examines 'drug user representation' in key UN drug policy processes over three decades. METHOD: A mapping process was undertaken using a corpus of publicly available documents from the UNGASS on Drugs and associated CND processes to identify relevant policy processes from 1987 to 2019 (n = 15) which were then assess for presence/absence of 'drug user representation'. Those processes with positive evidence of 'drug user representation' (n = 9) were critically interrogated across three co-constitutive domains of the subjects, objects and forms of 'drug user representation'. RESULTS: Our analysis shows that despite calls for greater involvement, dominant UN drug policy discourses and other practices delimit both the political subjectivities available to people who use/have used drugs and their capacity to bring their voices to bear in this context. The analysis also highlights that human rights-based discourses, employed by 'drug user representatives', have emerged as an important practice of resistance against the problematic and delimiting power effects of existing UN discourses, governing practices and modes of engagement. CONCLUSIONS: In addition to the practices of resistance being undertaken by 'drug user representatives', we suggest there is a need to improve how 'drug user representation' is being made possible and done in the sites of UN drug policy deliberation and, that these sites should be opened for questioning. This we argue will not only have a positive impact on political legitimacy for 'drug user representation', but on the health and human rights of people who use/have used drugs.

Exclusion and hospitality: the subtle dynamics of stigma in healthcare access for people emerging from alcohol and other drug treatment.

This article explores the role of drug use-related stigma in constraining access to healthcare services. Drawing on interviews with 20 people conducted shortly after leaving an Australian alcohol and other drug withdrawal management unit, the article explores their willingness and ability to access primary care, hospital and further services. It finds repeated descriptions of feeling ignored and shamed during efforts to access care, with some descriptions relating to subtle signs of disapproval or condemnation, and others to being ignored or dismissed. Some accounts additionally emphasise unwelcoming atmospheres, and exclusion by omission of signals of welcome and encouragement. The article goes on to consider, for the first time in this field, contemporary notions of welcome and hospitality as outlined within the cosmopolitanism tradition, asking whether they offer insights into how healthcare may become more accessible for people who regularly experience stigmatisation. In concluding, the article considers the need to think further about forms of exclusion that occur when social and individual histories of stigma are not institutionally recognised, and measures to counter these histories are not actively adopted.

Characterising the policy influence of peer-based drug user organisations in the context of hepatitis C elimination.

BACKGROUND: Achieving hepatitis C (HCV) elimination goals will require major policy and health service reorientation to scale up testing and treatment among people who inject drugs (PWID). To achieve this, a close partnership with peer-based drug user organisations is required. However, peer organisations have historical and ongoing difficulties in articulating the validity of their service delivery and policy advice, leading to some policy and health services resisting partnership and advice from peer-based drug user organisations. METHODS: To develop a deeper understanding of the role of peer-based drug user organisations in the HCV response, we analysed data from the W3 Project which used systems thinking methods to draw together the insights of over 90 peer staff from 10 Australian community and peer organisations in HCV and HIV. The resulting system maps were analysed to identify system dynamics and functions that need to be fulfilled for peer organisations to be influential within their community and policy system. RESULTS: We identified the interactions at a system level which can enhance or constrain the quality and influence of policy advice from peer-based drug user organisations. We found the strength of Peer-based drug user organisations to support the scale up of HCV testing and treatment was their capacity to mediate between, and navigate within, the complex community and policy/health service systems. While peer-based drug user organisations endeavour to demonstrate their capacity and credibility in terms of engagement, alignment, adaptation and influence, policy and service organisations also need recognise their own system role to value and enable peer-based drug user organisations to achieve their potential. CONCLUSION: If the HCV prevention and treatment system is to reach PWID living with HCV and achieve HCV elimination goals, then policy and health services need to invest in strengthening peer-based drug user organisations as well as recognise, value and act on quality policy advice from PWID peer leadership.

Acceptability of Patient-Reported Outcome and Experience Measures for Hepatitis C Treatment Among People Who Use Drugs.

BACKGROUND: Growing international interest in mechanisms to capture and measure experiences and outcomes of health interventions from the patient perspective has led to the development of patient-reported measures (PRMs) across many areas of medicine. Although PRMs are now well utilised in some settings, the rapidly expanding area of direct-acting antiviral (DAA) treatments for hepatitis C has received remarkably little attention. In addition, questions are also being raised about the extent to which patients have been involved in the development of PRMs, which are primarily designed to reflect the patient perspective. In this context, the aim of this paper was to explore the possibility of developing a new PRM for use in hepatitis C DAA therapy that would also be acceptable to the patient group, in this case people who inject drugs (PWID). METHOD: The study was based on a participatory design that included a peer researcher and foundational qualitative research including semi-structured interviews with 24 PWID with hepatitis C to inform the development of the PRMs. Stage 2 included four focus groups of six PWID with hepatitis C, who were asked to complete the draft measures and provide feedback. RESULTS: Participants responded positively to the draft PRMs. The results indicate that participants' concerns during DAA treatment are often not sufficiently attended to in clinical settings. In the light of this finding, participants reported that PRMs have a positive role to play in the negotiation of patients' care during DAA treatment. CONCLUSIONS: The findings show that utilising a participatory approach to the development of PRMs for DAA HCV treatment with PWID not only provides a way to measure experiences and outcomes of treatment from the patient perspective, but also provides a means for highly marginalised patient groups to have a say in and negotiate their care in ways that might not otherwise be possible.

Beyond interferon side effects: What residual barriers exist to DAA hepatitis C treatment for people who inject drugs?

Recent advances in the efficacy and tolerability of hepatitis C treatments and the introduction of a universal access scheme for the new Direct Acting Antiviral (DAA) therapies in March 2016, has resulted in a rapid increase in the uptake of hepatitis C treatment in Australia. Despite these positive developments, recent data suggest a plateauing of treatment numbers, indicating that more work may need to be done to identify and address ongoing barriers to hepatitis C treatment access and uptake. This paper aims to contribute to our understanding of the ongoing barriers to DAA therapies, with a focus on people who inject drugs. The paper draws on participant interview data from a qualitative research study based on a participatory research design that included a peer researcher with direct experience of both hepatitis C DAA treatment and injecting drug use at all stages of the research process. The study's findings show that residual barriers to DAA treatment exist at personal, provider and system levels and include poor venous access, DAA treatments not considered 'core-business' by opioid substitution treatment (OST) providers, and patients having to manage multiple health and social priorities that interfere with keeping medical appointments such as childcare and poor access to transport services. Further, efforts to increase access to and uptake of DAA hepatitis C treatment over time will require a focus on reducing stigma and discrimination towards people who inject drugs as this remains as a major barrier to care for many people.

A Systems Thinking Approach to Understanding and Demonstrating the Role of Peer-Led Programs and Leadership in the Response to HIV and Hepatitis C: Findings From the W3 Project.

The central role of community and peer-led programs has been a key characteristic of the Australian partnership response to HIV and hepatitis C since the beginning of the epidemics. Despite this, peer-led programs continue to have limited capacity to demonstrate their role and value as part of a multi-sectoral response. What makes one peer-led program a better investment than another? What role does the rest of the sector have in ensuring we gain the most value from these investments? To investigate this, we facilitated interactive systems thinking methods with 10 programs working within communities of people who inject drugs, gay men, sex workers and people living with HIV across Australia. This included articulating program theories in diagram and textual form to help us understand the role of peer-based programs promoting peer leadership within the Australian HIV and hepatitis C responses. Our aim was to develop a framework for monitoring and evaluation that could be applied to peer led programs at different levels and in different contexts. We found that for peer-led programs to fulfill their role, and to navigate the rapid changes occurring in the both epidemics, they need to: demonstrate the credibility of their peer and community insights; continually adapt to changing contexts and policy priorities in tandem with their communities; and maintain influence in both community and policy systems. We developed a framework of four key functions (Engagement, Alignment, Adaptation, and Influence) which peer-based programs need to demonstrate, which form the basis for identifying quality indicators. This article presents a new way of framing and monitoring investments in peer-led programs and peer eadership actions by these programs. If health policy is committed to strengthening the leadership shown by affected communities, then we need to understand, enhance, monitor and value the role of peer-led programs and peer leadership within the overall prevention system. We believe the W3 framework, drawing on systems thinking and modeling, can support funders, policy-makers and programs to achieve this.

Beyond cure: patient reported outcomes of hepatitis C treatment among people who inject drugs in Australia.

BACKGROUND: Recent advances in the treatment of hepatitis C virus (HCV) infection provide the possibility of eliminating HCV as a public health threat. This focus on HCV elimination through treatment, however, is also driving a concomitant focus on 'achieving cure' as the primary outcome of treatment. The aim of this paper is to explore what people who inject drugs consider to be important in relation to outcomes of HCV treatment, and whether there are outcomes 'beyond cure' that might be important to understand as part of improving engagement in treatment. METHODS: A peer researcher with experience of both HCV treatment and injecting drug use conducted interviews with 24 people in the following groups in Melbourne, Australia: (1) people who had refused or deferred HCV treatment; (2) people who were actively thinking about, planning and/or about to commence HCV treatment; (3) people currently undertaking HCV treatment and (4) people who had recently completed HCV treatment. RESULTS: The findings show that people who inject drugs are seeking outcomes 'beyond cure' including improved physical and mental health, positive changes in identity and social relationships and managing future health and risk. Participants indicated that these other outcomes had not been addressed within their experience of HCV treatment. CONCLUSION: While cure is an obvious outcome of HCV treatment, patients are seeking change in other areas of their lives. This study also provides valuable insights for the development of patient-reported measures in this context, which would be an important step towards more patient-centred approaches to HCV treatment.

'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.

Re-examining blood donor deferral criteria relating to injecting drug use.

BACKGROUND AND AIMS: Potential Australian blood donors are deferred indefinitely if they report a history of injecting drug use (IDU), or for 12 months if they report having engaged in sexual activity with someone who might have ever injected. Given incremental improvements in blood safety, this study sought to examine whether Australia's IDU-related eligibility criteria reflected current scientific evidence, were consistent with international best practice and, if current IDU-related policies were to be changed, how this should happen. METHODS: An expert committee was formed to review relevant literature with a focus on issues including: the epidemiology of IDU in Australia and key transfusion-transmissible infections (TTIs) among Australian people who inject drugs (PWID); and, 'non-compliance' among PWID regarding IDU-related blood donation guidelines. International policies relating to blood donation and IDU were also reviewed. Modelling with available data estimated the risk of TTIs remaining undetected if the Blood Service's IDU-related guidelines were changed. RESULTS: Very few (<1%) Australians engage in IDU, and IDU risk practices are reported by only a minority of PWID. However, the prevalence of HCV remains high among PWID, and IDU remains a key transmission route for various TTIs. Insufficient data were available to inform appropriate estimates of cessation and relapse among Australian PWID. Modelling findings indicated that the risk of not detecting HIV becomes greater than the reference group at a threshold of non-admission of being an active PWID of around 1.8% (0.5-5.1%). Excluding Japan, all Organisation for the Economic Co-operation and Development member countries permanently exclude individuals with a history of IDU from donating. CONCLUSION: Numerous research gaps meant that the study's expert Review Committee was unable to recommend altering Australia's current IDU-related blood donation guidelines. However, having identified critical knowledge gaps and future areas of research, the review made important steps toward changing the criteria.

HIV, HCV, and Health-Related Harms Among Women Who Inject Drugs: Implications for Prevention and Treatment.

BACKGROUND: Although an estimated 3.5 million women inject drugs globally, women are outnumbered 4 to one by men who inject drugs and are often ignored or overlooked in the development and delivery of prevention and treatment services for this population. This study aimed to identify key comorbidities prevalent among women who inject drugs (WWID), consider factors that contribute to vulnerability of this population, and examine implications for prevention and treatment. METHODS: The literature was reviewed to examine the specific challenges and needs of WWID. We searched health-related bibliographic databases and grey literature to identify studies conducted among WWID and studies conducted among people who inject drugs (PWID), where results were disaggregated by gender and policies/guidelines/reports relevant to WWID. RESULTS: WWID face a range of unique, gender-specific, and often additional challenges and barriers. The lack of a targeted focus on WWID by prevention and treatment services and harm-reduction programs increases women's vulnerability to a range of health-related harms, including blood-borne viral and sexually transmitted infections, injection-related injuries, mental health issues, physical and sexual violence, poor sexual and reproductive health, issues in relation to childbearing and child care, and pervasive stigma and discrimination. CONCLUSIONS: There is a need to improve the collection and reporting of gender-disaggregated data on prevalence of key infections and prevention and treatment service access and program coverage. Women-focussed services and integrating gender equity and human rights into the harm-reduction programming will be a prerequisite if improvements in the health, safety, and well-being of this often invisible and highly vulnerable population are to be achieved.

Assessing the feasibility of hepatitis C virus vaccine trials: results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study.

Efficacy trials of preventive hepatitis C virus (HCV) vaccine candidates raise challenging scientific and ethical issues. Based on data from the first 3 years of a community-based prospective observational study - the Hepatitis C Incidence and Transmission Study-community (HITS-c) - this paper examines the feasibility of conducting trials of candidate HCV vaccines with people who inject drugs (PWID) in Sydney, Australia. Of the 166 PWID confirmed HCV antibody negative and eligible for enrolment, 156 (94%) completed baseline procedures. Retention was high, with 89% of participants retained at 48 weeks and 76% of participants completing at least 75% of study visits within 2 weeks of schedule. The rate of primary HCV infection was 7.9/100 py (95% CI 4.9, 12.7). Of the 17 incident cases, 16 completed at least one follow-up assessment and 12 (75%) had evidence of chronic viraemia with progression to chronic HCV infection estimated to be 6/100 py. Power calculations suggest a chronic HCV infection rate of at least 12/100 py (primary HCV infection rate 16/100 py) will be required for stand-alone trials of highly efficacious candidates designed to prevent chronic infection. However, elevated primary HCV infection was observed among participants not receiving opioid substitution therapy who reported heroin as the main drug injected (26.9/100 py, 95% CI 14.5, 50.0) and those who reported unstable housing (23.5/100 py, 95% CI 7.6, 72.8), daily or more frequent injecting (22.7/100 py, 95% CI 12.2, 42.2) and receptive syringe sharing (23.6/100 py, 95% CI 9.8, 56.7) in the 6 months prior to baseline. These data suggest that it is possible to recruit and retain at-risk PWID who adhere to study protocols and that modification of eligibility criteria may identify populations with sufficiently high HCV incidence. Results support the feasibility of large multi-centre HCV vaccine trials, including in the Australian setting.

Australia's response to HIV among people who inject drugs.

Australia's prompt and effective response to HIV among people who inject drugs is recognized internationally. In the early 1980s, there was growing awareness of the evolving threat presented by HIV. Despite erroneous but commonly held assumptions that people who inject drugs generally disregard their health, injecting drug users contributed significantly to Australia's response to HIV. They formed peer-based organizations which advocated for: engaging affected communities in policy development and implementation; funding for peer education; and access to sterile injecting equipment. While government fear of appearing to condone injecting illicit drugs delayed the bi-partisan political support needed to implement programs to provide readily accessible sterile injecting equipment, needles and syringe programs were established relatively quickly. Strong evidence supports the effectiveness, safety, and cost-effectiveness of Australia's early, decisive, and pragmatic public health and human rights-based approach. Without a comprehensive package of harm reduction and peer-based responses, HIV epidemics can develop rapidly among and from people who inject drugs.

Contraception, punishment and women who use drugs.

BACKGROUND: In light of the recent debate on the use of financial incentives to promote long-acting contraception and sterilisation among women who use illicit drugs we discuss attitudes to contraception, pregnancy and parenting among Australian women who inject drugs. METHODS: Qualitative interviews were conducted with 90 women of reproductive age about contraceptive use, preferences, reproductive histories, attitudes to and experiences of parenting. All women were either currently, or had previously injected drugs. The in-depth, semi-structured interviews were compared and contrasted for themes relating to drug use, contraception, pregnancy and parenting. RESULTS: Participants aspired to control their fertility, expressed individual contraceptive preferences and concerns for their children (both born and unborn). Most had tried a number of contraceptive methods interspersed by periods of non-use related to experiences of side-effects, being single or abstinent, believing that they were infertile and trying to conceive. Attitudes varied from woman to woman and in the same individual over their life course. Some believed that they were not likely to be capable, but most aspired to be successful mothers. CONCLUSIONS: Women's drug use should not automatically be associated with an inability to make informed health care choices or to care for children. Evidence suggests that women who use drugs do not need to be paid to limit or end their fertility. Rather, programs that aim to reduce barriers to obtaining free, non-discriminating reproductive advice and parenting assistance would better utilise women's agency to improve their own reproductive health.

Increased hepatitis C virus vaccine clinical trial literacy following a brief intervention among people who inject drugs.

INTRODUCTION AND AIMS: While people who inject drugs are at high risk of hepatitis C virus (HCV) infection and will be the target population for future HCV vaccine trials, little is known about clinical trial literacy (CTL) in this group. We assessed the impact of a brief intervention (BI) designed to improve HCV vaccine CTL among people who inject drugs in Sydney, Australia. DESIGN AND METHODS: People who inject drugs enrolled in a community-based prospective observational study between November 2008 and September 2010 (n = 102) completed a CTL assessment followed immediately by the BI. Post-test assessment was conducted at 24 weeks. RESULTS: The median age of the sample was 27 years, 73% were male and 60% had 10 or less years of schooling. The median time since first injection was 5 years and 20% reported daily or more frequent injecting. The mean number of correct responses increased from 5.3 to 6.3/10 (t = -4.2; 101df, P < 0.001) 24 weeks post-intervention. Statistically significant differences were observed for three knowledge items with higher proportions of participants correctly answering questions related to randomisation (P = 0.002), blinding (P = 0.005) and vaccine-induced seropositivity (P = 0.003) post-intervention. DISCUSSION AND CONCLUSIONS: A significant increase in HCV vaccine CTL was observed, suggesting that new and relatively novel concepts can be learned and recalled in this group. These findings support the feasibility of future trials among this population. [Correction added on 21 November 2012, after first online publication: T-score for mean number of correct responses was corrected to '-4.2' in the Results section.]