This trial is registered as ISRCTN66453696 and PROSPERO 014:CRD42014012969.
Funding
Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research.
DOI: 10.3310/hta21720 HEALTH TECHNOLOGY ASSESSMENT 2017 VOL. 21 NO. 72
© Queen’s Printer and Controller of HMSO 2017. This work was produced by Gilchristet al.under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Chapter 1
Introduction and background
T
his report presents the findings from a Health Technology Assessment (HTA)-funded programme of work to develop an evidence-based psychosocial intervention aimed at reducing blood-borne virus (BBV) transmission risk behaviours and increasing BBV transmission knowledge among people who inject drugs (PWID), and explore the feasibility of recruiting PWID to a trial comparing the intervention with control. This first chapter provides the background and rationale for conducting this research, and describes the research objectives. The remainder of the report is divided into the following chapters representing the phases of the study:Chapter 2, Determining the evidence base: a systematic review of psychosocial interventions to reduce drug and sexual blood-borne virus transmission risk behaviours among people who inject drugs;Chapter 3, Understanding people who inject drugs’influences on behaviour and views on psychosocial interventions;Chapter 4, Consultation with key stakeholders on the delivery and effectiveness of psychosocial interventions to reduce blood-borne virus transmission risks among people who inject drugs;Chapter 5, Intervention development;Chapter 6, Feasibility trial;Chapter 7, Protocol changes; Chapter 8, Implications and dissemination of findings; andChapter 9, Discussion and conclusions.Background
Prevalence
Preventing the transmission of BBVs among PWID is a major public health issue. Hepatitis C virus (HCV) is the most prevalent BBV among PWID, with 56% in Scotland (61% among needle exchange attenders),1
approximately 50% in England and Wales and 23% in Northern Ireland being HCV positive.2The rate of
human immunodeficiency virus (HIV) and hepatitis B virus (HBV) infection among PWID in the UK is low, ranging from 0% in Wales and Northern Ireland to 1.4% in England for HIV and from 6% in Northern Ireland to 18% in England for HBV.2
Risk factors for blood-borne viruses
Hepatitis B virus and HIV are transmitted via blood or body fluids. Sharing injecting equipment poses the greatest risk of HCV transmission among PWID.3Although there is no increased risk of HCV transmission in
a long-term heterosexual relationship, the risk of transmission increases with multiple sexual partners and among women who are infected with HIV or other sexually transmitted diseases.4Sex trading, younger
age, cocaine injecting, depression, requiring help injecting, having unsafe sex with a regular partner and having an HIV-positive sexual partner are associated with HIV infection among PWID.5–9Risk factors for
HCV among PWID include sharing needles and other injection equipment,10longer duration of injecting
career,11increased frequency of injection,11,12requiring help injecting,13being female14and a history
of imprisonment.11,12Research suggests that a gap in HCV transmission knowledge among PWID is
contributing to the high prevalence.15–17Higher HIV and HCV infection rates have been reported among
people with mental health disorders.6,18,19PWID with mental health disorders report greater sharing of
injection equipment, lower rates of condom use, multiple sexual partners, sex trading and having sex with PWID.5,6,20,21Depressive symptoms are also associated with drug21–23and sexual risk behaviours.23–25The
prevalence of intimate partner violence is high among people who use drugs.23,26,27Women who are
survivors of intimate partner violence are less likely to use condoms and more likely to share needles, to have multiple sexual partners and to trade sex,26,28all of which increase susceptibility to BBV transmission.28
BBV transmission risk behaviours should be understood in the context of PWIDs’sexual and drug-using relationships.29Some females who inject drugs share injecting equipment with their partners for trust and
intimacy, perceiving less risk in such relationships.30
Current policy and practice
Policy and practice with regard to public health generally, and the management of BBVs specifically, are driven by different policies and agendas in the four nations of the UK, although the overarching recovery
DOI: 10.3310/hta21720 HEALTH TECHNOLOGY ASSESSMENT 2017 VOL. 21 NO. 72
© Queen’s Printer and Controller of HMSO 2017. This work was produced by Gilchristet al.under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
agenda has dominated drug policy for a number of years.31In Scotland,The Road to Recovery: A New
Approach to Tackling Scotland’s Drug Problemwas published in 2008,32and recovery became a central
tenet of UK policy in 2010.33In a corresponding publication,Putting Full Recovery First: The Recovery
Roadmap,34the authors outlined the roadmap for the ways in which recovery would be fostered in
communities in England and Wales, including the creation and utilisation of‘recovery champions’.34
Although the rhetoric of drug policy may have altered in the UK over the last 8 years from that of harm reduction to that of recovery, the extent to which the realities of drug treatment provision (including prevention) have changed remains largely unknown. Indeed, as commented by Duke‘at the level of practice, it will be interesting to examine how day-to-day practice develops and changes with drug users under the new framework’.31
With specific regard to the management and prevention of BBV infections, and HCV in particular, all four nations published their first action plans for the prevention and management of HCV around 10 years ago, and have had varying degrees of success. Very broadly, the action plans in all four countries set out key objectives that would need to be achieved in the realms of HCV prevention and treatment, with particular foci on PWID, in order to tackle the burden of HCV on individuals and on public health. Common
objectives of the plans included developing a better evidence base for establishing prevalence figures through better monitoring and surveillance systems; increasing information on the disease; increasing the number of persons being tested and, therefore, diagnosed with HCV (as high numbers of people with the disease are undiagnosed); and increasing the number of people entering into treatment for HCV infection. It might be argued that harm reduction, rather than recovery, has been at the heart of the HCV action plans in the sense that other objectives of the plans involved not only providing more needle exchange outlets (including outreach distribution, as in Northern Ireland), but also increasing the number of needles, syringes and other injecting equipment that PWID can access.
Harm reduction approaches recognise that there is a need to reduce the risks associated with drug misuse (including injecting). This approach is facilitated in the UK by the provision of opioid substitution therapy (OST; e.g. with methadone or buprenorphine), key worker support, needle and syringe programmes that offer PWID free injecting equipment (and equipment), and information to reduce sharing behaviour and, therefore, the transmission of BBV, as well as support for stopping injecting. The use of psychosocial interventions to reduce risk behaviours among PWID is not routinely practised in the UK. Harm reduction messages are mainly provided by key workers, drug treatment staff and needle exchange staff, peer educators and BBV nurses.
Harm reduction approaches
Although advances have been made in treatment and pre-exposure prophylaxis for HIV infections and a vaccine is available for HBV, there is currently no vaccine available to prevent HCV infection. There is evidence to suggest that OST and needle exchanges35–38are effective in reducing HIV and HCV infection
prevalence among PWID. However, recent research stresses that, although increasing the coverage of these interventions can reduce HCV prevalence among PWID, these reductions are modest and psychosocial interventions are required to further decrease HCV prevalence36by informing PWID about
transmission risks and motivating them to reduce risky sexual and drug-taking behaviours. Although OST has been successful in reducing BBV, some PWID continue to inject and, therefore, may be at risk of acquiring or transmitting BBV. A meta-analysis found that the incidence of HCV reinfection following successful treatment for HCV among PWID was 2.4 per 100 person-years and 6.4 per 100 person-years among those who reported injecting drug use post sustained viral response (SVR).39A recent retrospective
record linkage study in Scotland reported similar reinfection rates, 1.7 per 100 person-years among PWID and 5.7 per 100 person-years among those who had been admitted to hospital for injection-related causes.40Although there is a low risk of reinfection following successful treatment for HCV, a large cohort
study in Scotland found that 10.6% of 1170 PWID who had achieved a SVR following treatment for HCV had been hospitalised for, or had died from, an injection-related cause in the first 3 years post SVR.41
Moreover, findings highlight a rise in injection-related hospitalisation or death with time with increasing year of SVR attainment. In addition, women were more likely to have multiple injection-related
INTRODUCTION AND BACKGROUND
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hospitalisations post SVR. These findings highlight that‘harm reduction interventions aimed at reducing the risk of HCV transmission should also continue to be promoted once treatment ceases’.41
Recent systematic reviews and meta-analyses of psychosocial interventions to reduce HIV and HCV risk behaviours among PWID have reported modest effects42–44and conclude that
‘limited progress [has been
made] in developing more effective interventions’43and that
‘multi-component interventions are required’.44
A recent Cochrane review onPsychosocial Interventions for Reducing Injection and Sexual Risk Behaviour for Preventing HIV in Drug Users43reported minimal differences identified between multisession psychosocial
interventions and standard educational interventions for both injection and sexual risk behaviour. However, there were large pre–post changes for both groups, suggesting that both were effective in reducing risk behaviours. They also found evidence of benefit for multisession psychosocial interventions when compared with minimal controls. Moreover, people in formal treatment were more likely to respond to multisession psychosocial interventions, and single-gender groups were associated with greater benefit.
Harm reduction approaches mostly address risk factors associated with the sharing of injecting equipment and unprotected sex. Research has highlighted that PWID sometimes have different priorities, such as avoiding injecting-related scars or marks and maintaining venous access, which results in the use of sterile injecting equipment.45PWID have also stressed a need for
‘non-judgemental venous care and access advice’.45PWID
who plan ahead to ensure that they have access to sterile injecting equipment are more likely to store clean needles; avoid sharing needles and syringes and other injecting equipment; and provide clean needles to sex partners.46Therefore, it is vital that harm reduction interventions include protective practices and
strategies to avoid and plan for injecting risk situations, such as withdrawal and lack of preparedness.47,48
Research has demonstrated that‘symbiotic’goals that are not directly focused on BBV risk reduction are important to PWID, such as avoiding withdrawal, maintaining social support, venous access and care, and image management,45,49and may help them to
‘stay safe’and avoid BBV.50Strategies described to avoid
withdrawal include‘back up methods, resorting to credit, collaborating with others, regimenting drug intake, balancing drug intake with money available, and/or resorting to treatment’.47PWID who have not
become infected with HCV report protective practices, including principles about normative injecting practices; preparedness and contingency planning to avoid disruption to risk management; and the capacity for flexibility to adapt to changes in normative practices or intentions.51