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PROTECT - Preventing blood borne virus infection in people who inject drugs in the UK: intervention development and feasibility study

A psychosocial, gender-specific group intervention delivered by trained facilitators aimed at preventing the spread of blood borne virusus in people who inject drugs was developed and tested. The intervention was acceptable to both participants and facilitators, but the attendance rates indicate a full RCT would not be feasible.

Why did we do this research?

People who inject drugs (PWID) are at risk of blood borne viruses (BBV) such as Hepatitis B, Hepatitis C and HIV as a result of sharing injecting equipment (needles and syringes, water, spoons, cotton etc) and unsafe sex. Preventing PWID from getting or passing on these viruses is an important health issue. Interventions such as opiate substitution therapy (methadone or buprenorphine) and needle exchanges have reduced BBV in this population. There is however a potential to further prevent the spread of BBV through 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.

What did we do?

This was a mixed methods project with 6 complementary phases. Phases 1-3 gathered the information required to develop an evidence based intervention and Phase 4 was intervention development.

Phase 5 was a pragmatic, two-armed randomised controlled, open feasibility trial. Participants were randomised to either a three-session, manualised, psychosocial, gender-specific group intervention delivered by trained facilitators and BBV transmission information booklet plus treatment as usual (TAU), or information booklet plus TAU. The main outcome measures were recruitment, retention and follow-up rates for feasibility. Feedback questionnaires, focus groups with participants who attended at least one intervention session and facilitators assessed the intervention’s acceptability.

In Phase 6, the results have been presented to inform the design of future research. The Department of Health Sciences at the University of York was involved in Phases 1, 2, 5 and 6, including the cost-effectiveness component.

Who was involved?

Participants were current PWID, aged 18 years and over. They were recruited at NHS or third-sector drug treatment or needle exchanges in Glasgow, London, Wrexham and York.

Service users were Steering Group members and co-developed the intervention. Peer educators co-delivered the intervention in London.

What did we find?

Fifty-six per cent (99/176) of eligible PWID were randomised: 52 to the intervention group and 47 to the control group. Only 19% of participants attended all three intervention sessions and 47% were followed up 1 month post intervention. Variations were reported by location. The intervention was acceptable to both participants and facilitators. At 1 month post intervention, no increase in injecting in ‘risky’ sites (e.g. groin, neck) was reported by participants who attended at least one session. PWID who attended at least one session showed a trend towards greater reduction in injecting risk behaviours, a greater increase in withdrawal planning and were more confident about finding a vein. No adverse events were reported. Given the attendance rates, a future definitive randomised controlled trial of the intervention is not feasible. 

Publications

• Gilchrist G, Swan D, Shaw A, Keding A, Towers S, Craine N, et al. Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial. Health Technol Assess 2017;21(72) https://doi.org/10.3310/hta21720
• Gilchrist, G., Swan, D., Widyaratna, K. et al. A Systematic Review and Meta-analysis of Psychosocial Interventions to Reduce Drug and Sexual Blood Borne Virus Risk Behaviours Among People Who Inject Drugs. AIDS Behav 21, 1791–1811 (2017). https://doi.org/10.1007/s10461-017-1755-0 
• Gilchrist, G., Swan, D., Shaw, A. et al. The acceptability and feasibility of a brief psychosocial intervention to reduce blood-borne virus risk behaviours among people who inject drugs: a randomised control feasibility trial of a psychosocial intervention (the PROTECT study) versus treatment as usual. Harm Reduct J 14, 14 (2017). https://doi.org/10.1186/s12954-017-0142-5

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