Preventing blood borne virus infection in people who inject drugs (project PROTECT)
Study funded by NIHR Health Technology Assessment ref: 13/17/04
Need for the project
In the UK, around 33%-56% of people who inject drugs (PWID) have Hepatitis C. Rates of HIV (0-1%) and Hepatitis B (6-18%) are much lower. PWID are at risk of these blood borne viruses (BBV) as a result of sharing injecting equipment (needles and syringes, water, spoons, cotton etc) and unsafe sex. Opiate substitution therapy (methadone or buprenorphine) and needle exchanges have reduced BBV but behavioural interventions such as individual or group brief or multi-session interventions led by peers or staff that teach PWID how to reduce risk behaviours could further prevent the spread of BBV. There remains a need to find out what kind of behavioural intervention PWID would find useful, whether they would attend the intervention and whether it would reduce BBV transmission risk behaviours.
Phases of the project
In Phase 1, a systematic review of the international and UK literature on what type of intervention works in which setting will be assessed. In Phase 2, the views of 60 PWID attending needle exchanges, homeless hostels, drug treatment and harm reduction centres in England (London, Yorkshire), Scotland (Glasgow) and North Wales will be sought on what type of psychosocial interventions they would find useful and acceptable (e.g. content, number of sessions, who should deliver the intervention, information they would find helpful). In Phase 3, the views of 40 UK (from England, Scotland, Northern Ireland and Wales) drug treatment NHS and third sector service providers and policy makers (including but not limited to: the Scottish Executive, Department of Health, Welsh Government, UK Government, Public Health Agency Northern Ireland) will be gathered using telephone interviews on the delivery and effectiveness of psychosocial interventions. Findings from Phases 1-3 will be used to develop a psychosocial intervention in Phase 4, incorporating existing and new evidence and what PWID and service providers and commissioners want and think is needed. In Phase 5, a trial will be conducted among 128 PWID in 4 different UK regions to assess the feasibility and acceptability of the psychosocial intervention developed in Phase 4. Findings will inform the parameters of a future multisite efficacy RCT including the number of eligible participants, the willingness of participants to consent and be randomised, adherence and compliance rates, confirmation of the suitability of 'reduction of risk behaviours' and 'increase of BBV transmission knowledge' as appropriate outcome measures, expected variability of these outcome measures, follow-up rates and response rates to questionnaires. In total, 128 (64 men) PWID attending NHS and third sector drug treatment (64 PWID) or needle exchanges (64 PWID) in London, York, Yorkshire, Glasgow and North Wales will be allocated at random to the group psychosocial intervention or to receive an information leaflet about the risks of BBV. All participants will continue to receive their usual care. Differences in number of risk events (e.g. sharing needles, cotton, water etc) in past month will be assessed pre, end and 1 month post intervention using intention-to-treat analysis. Focus groups with PWID who attended and staff who delivered the intervention will be conducted at the conclusion of the intervention to elicit their experience and help to identify any problems the intervention. In Phase 6, discussions with another 4-6 UK regions will take place to identify any challenges with conducting the research/ introducing the psychosocial intervention to their treatment settings in the future. This phase will facilitate the development of a future multisite RCT of the intervention including these additional 4-6 regions involved in this phase.
The study is led by Dr Gail Gilchrist (King’s College London), with co-applicants at The University of the West of Scotland and The University of York. NHS Wales and The University of Huddersfield are also collaborating in the project. Details of the research team can be found below:
King's College London
The University of York
The University of the West of Scotland
The University of Huddersfield