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.
While opiate substitution therapy and injecting equipment provision (IEP) have reduced blood-borne viruses (BBV) among people who inject drugs (PWID), some PWID continue to share injecting equipment and acquire BBV. Psychosocial interventions that address risk behaviours could reduce BBV transmission among PWID.



A pragmatic, two-armed randomised controlled, open feasibility study of PWID attending drug treatment or IEP in four UK regions. Ninety-nine PWID were randomly allocated to receive a three-session manualised psychosocial group intervention and BBV transmission information booklet plus treatment as usual (TAU) (n = 52) or information booklet plus TAU (n = 47). The intervention was developed from evidence-based literature, qualitative interviews with PWID, key stakeholder consultations, and expert opinion. Recruitment rates, retention in treatment, follow-up completion rates and health economic data completion measured feasibility.



Fifty-six percent (99/176) of eligible PWID were recruited. More participants attended at least one intervention session in London (10/16; 63%) and North Wales (7/13; 54%) than in Glasgow (3/12; 25%) and York (0/11). Participants who attended no sessions (n = 32) compared to those attending at least one (n = 20) session were more likely to be homeless (56 vs 25%, p = 0.044), injected drugs for a greater number of days (median 25 vs 6.5, p = 0.019) and used a greater number of needles from an IEP in the last month (median 31 vs 20, p = 0.056). No adverse events were reported. 45.5% (45/99) were followed up 1 month post-intervention. Feedback forms confirmed that the intervention was acceptable to both intervention facilitators and participants who attended it. Follow-up attendance was associated with fewer days of injecting in the last month (median 14 vs 27, p = 0.030) and fewer injections of cocaine (13 vs 30%, p = 0.063). Analysis of the questionnaires identified several service use questionnaire categories that could be excluded from the assessment battery in a full-randomised controlled trial.



Findings should be interpreted with caution due to small sample sizes. A future definitive RCT of the psychosocial intervention is not feasible. The complex needs of some PWID may have limited their engagement in the intervention. More flexible delivery methods may have greater reach.



ISRCTN66453696.
Institute of Psychiatry, Psychology and Neuroscience, King's College London, Addictions Sciences Building, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, England, UK. gail.gilchrist@kcl.ac.uk.
Gail
G
Gilchrist
Institute of Psychiatry, Psychology and Neuroscience, King's College London, Addictions Sciences Building, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, England, UK.
Davina
D
Swan
School of Media, Culture & Society, University of the West of Scotland, Paisley Campus, High Street, Paisley, PA1 2BE, Scotland, UK.
April
A
Shaw
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, England, UK.
Ada
A
Keding
Betsi Cadwaladr University Hospital Trust, 10 Grove Road, Wrexham, LL11 1DY, Wales, UK.
Sarah
S
Towers
Public Health Wales, Microbiology Department, Ysbyty Gwynedd, Bangor, Gwynedd, LL57 2PW, Wales, UK.
Noel
N
Craine
School of Media, Culture & Society, University of the West of Scotland, Paisley Campus, High Street, Paisley, PA1 2BE, Scotland, UK.
Alison
A
Munro
School of Health and Human Sciences, University of Huddersfield, Queensgate, Huddersfield, West Yorkshire, HD1 3DH, England, UK.
Elizabeth
E
Hughes
Department of Health Sciences, University of York, Heslington, York, YO10 5DD, England, UK.
Steve
S
Parrott
Institute of Psychiatry, Psychology and Neuroscience, King's College London, Addictions Sciences Building, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, England, UK.
John
J
Strang
School of Media, Culture & Society, University of the West of Scotland, Paisley Campus, High Street, Paisley, PA1 2BE, Scotland, UK.
Avril
A
Taylor
York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, England, UK.
Judith
J
Watson
D000328:Adult; D017848:Blood-Borne Pathogens; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D040261:Harm Reduction; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D010353:Patient Education as Topic / Q000379:methods*; D011613:Psychotherapy / Q000379:methods*; D012309:Risk-Taking; D015819:Substance Abuse, Intravenous / Q000628:therapy*; D006113:United Kingdom; D014777:Virus Diseases / Q000517:prevention & control*; D055815:Young Adult
Blood-borne virus transmission; Feasibility randomised controlled trial; Focus group research; People who inject drugs; Psychosocial interventions