Title: Preventing blood borne virus infection in people who inject drugs in the UK: the development and feasibility of psychosocial interventions
Funder: Department of Health (England)

Abstract: DESIGN Mixed methods project with 6 complementary phases. AIM 1) To develop an evidence based psychosocial intervention to reduce transmission risks among IDU at risk of acquiring or transmitting blood-borne viruses(BBV) (target group) 2) conduct a feasibility randomised controlled trial(RCT) of the intervention. PHASE 1. DETERMINING THE EVIDENCE BASE A systematic review of efficacy of psychosocial interventions to reduce Hepatitis C risk behaviours conducted in 2012 by PI Gilchrist for the REDUCE project will be updated to include HIV & Hepatitis B. Medline CINAHL PsycINFO & Cochrane databases will be searched. Trials will be assessed using Cochrane risk of bias tool & reported using PRISMA statement. A scoping review of UK grey literature will also be conducted. UK commissioning drug partnerships (previously drug Action Teams) will be contacted to source available interventions. All interventions will be reviewed. PHASE 2. UNDERSTANDING IDUS INFLUENCES ON BEHAVIOUR & VIEWS ON PSYCHOSOCIAL INTERVENTIONS Indepth interviews with a purposive sample of 60 IDU (15 from London Yorkshire Glasgow & North Wales) from needle exchanges & drug treatment will elicit the influences on risk behaviours & determine the content & preferred mode of intervention delivery. PHASE 3. KEY STAKEHOLDERS’ VIEWS ON THE DELIVERY & EFFECTIVENESS OF PSYCHOSOCIAL INTERVENTIONS 40 national & local stakeholders including service providers policy makers & commissioners with responsibility for BBV will be interviewed indepth by telephone (10 from Scotland England Wales & Northern Ireland) to determine their views on whether psychosocial interventions are effective & how they should be delivered. All interviews will be recorded & transcribed verbatim. A qualitative research framework approach will be used for analysis. PHASE 4. INTERVENTION DEVELOPMENT Informed by Phases 1-3 previous effective interventions & the REDUCE intervention will be adapted where possible. The intervention will be brief & contain core sessions with optional sessions for specific high risk IDU–including the homeless prostitutes women & BME groups. A working group of clinical experts interventionists & service users will develop the intervention. PHASE 5. FEASIBILITY RCT A feasibility RCT will be conducted in 4 regions (London Glasgow Yorkshire North Wales) among 128 IDU to determine whether the study can be done & inform parameters for a definitive RCT & economic evaluation. In each region 16 IDU from drug treatment services & 16 from needle & syringe exchanges will be randomly allocated to receive the intervention or an information leaflet. A mix of NHS & 3rd sector services will be recruited. Differences in number of risk events in past month will be assessed pre end & 1 month post intervention using intention-to-treat analysis. Focus groups will examine IDU & staff experience of receiving/delivering the intervention & identify issues to its uptake & delivery. PHASE 6. PREPARATION FOR MULTISITE TRIAL Discussions with additional UK regions regarding a future multisite trial will ensure any challenges to implementation in other regions/communities are considered. EXPERTISE Team includes addiction & BBV experts in systematic reviews intervention development clinical trials & health economics. Service users providers & academics will be members of intervention development & project steering groups.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH;INFECTION