Plain English Summary
Background and study aims
In the UK, between 33%-56% of people who inject drugs (PWID) suffer from one or more of the blood borne viruses (BBV) Hepatitis C, HIV or Hepatitis B as a result of sharing injecting equipment (needles and syringes, water, spoons, cotton etc) and also unsafe sex. New injectors, those who are homeless, prostitutes and women are more likely to become infected. Preventing PWID from getting or passing on these viruses is an important health issue. Opiate substitution therapy (methadone or buprenorphine) and needle exchanges have reduced BBV infections but behavioural interventions (treatments) such as individual or group therapy sessions that teach PWID how to reduce their risk of becoming infected could further prevent the spread of BBV. Most studies looking at behavioural inventions to reduce the risk of BBV infection have been carried out in the USA. There is therefore a need to develop treatments that are relevant to UK PWID and the UK drug treatment system. We need to find out what kind of behavioural intervention PWID would find useful, whether they would attend the intervention and whether it would stop them from behaving in ways most likely to lead to BBV infection.
Who can participate?
PWID aged at least 18 attending drug treatment clinics and needle exchange programs.
What does the study involve?
The project has a number of phases. These include a literature review to find out what type of intervention may work in different settings, collecting the views of PWID on what sort of interventions they would find useful (and are most likely to attend) and also collecting the views of drug treatment centres and relevant policy makers on how to provide possible psychosocial interventions and how successful they may be. Altogether, these findings are used to develop a new psychosocial intervention. In the last stage (phase 5), a trial takes place to see whether the newly developed intervention is feasible and acceptable to PWID. All participants taking part in this trial are randomly allocated into one of two groups. Those in group 1 attend a small number (1-4) of psychosocial group sessions while still getting their usual treatment. It covers understanding BBV infection risks, motivation for change, and safer injecting and sexual practices. Those in group 2 (control group) are given an information leaflet on reducing the passing on (transmission) of BBVs as well as receive their usual treatment.
What are the possible benefits and risks of participating?
Possible benefits will be better knowledge on the transmission of BBVs
Where is the study run from?
King's College London (UK)
When is the study starting and how long is it expected to run for?
October 2015 to May 2016
Who is funding the study?
NIHR HTA (UK)
Who is the main contact?
Dr Gail Gilchrist
Gail.Gilchrist@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gail Gilchrist
ORCID ID
Contact details
National Addiction Centre
Addictions Department
Institute of Psychiatry
Kings College London
Addictions Sciences Building
4 Windsor Walk
Denmark Hill
London
SE5 8BB
United Kingdom
-
Gail.Gilchrist@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 13/17/04
Study information
Scientific title
Feasibility of psychosocial interventions for preventing blood borne virus infection in people who inject drugs: a feasibility randomised controlled trial
Acronym
Study hypothesis
The proposed project will develop an evidence based psychosocial intervention to reduce blood borne viruses (BBV) and increase BBV transmission knowledge among people who inject drugs (PWID), and conduct a feasibility trial, comparing the psychosocial intervention to an information leaflet, to inform the future parameters of a large multisite RCT. The hypothesis for the full trial is that the psychosocial intervention will be more effective in reducing BBV risk behaviours and increasing BBV transmission knowledge than an information leaflet.
More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/131704/#/
Protocol can be found at: https://njl-admin.nihr.ac.uk/document/download/2007288
Ethics approval
The Integrated Research Approval System will be used to gain ethical and R&D approval to conduct the study. This approval is not required till Phases 2 and 3 of the project (month 5 and 8 respectively) and for the feasibility trial in Phase 5 of the project (month 12); therefore, it is not possible to get ethical approval for the feasibility study until the intervention has been developed.
Study design
Feasibility randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Blood borne viruses among people who inject drugs
Intervention
All participants in the feasibility trial will receive treatment as usual in addition to the trial interventions. In community addiction treatment, treatment as usual in NHS/ 3rd sector Community Addiction treatment in the UK is fortnightly tier 3 key work/care planning (based on the National Treatment Agency models of care, 2006) delivered by a drug worker. In needle and syringe exchange programmes, injecting equipment and paraphernalia is supplied free of charge, and service users can exchange/ return used syringes. Injecting and harm reduction advice and physical health care (treatment of wounds etc) is provided as required. The HTA assesses the value of a health technology (i.e. the evidence based psychosocial intervention) compared to the best alternative (currently an information leaflet). Psychosocial interventions to reduce BBV risk behaviours and transmission are not standard practice in NHS and third sector treatment in the UK. Previous studies have compared psychosocial interventions to video and leaflet information sessions [e.g. 36,38], therefore we consider the proposed approach to be ethical.
1. Intervention arm:
A psychosocial intervention will be developed in Phase 4. Participants randomly allocated to the intervention arm will participate in a psychosocial group (brief) intervention (estimated 1-4 sessions) facilitated by a drugs worker. They will also receive treatment as usual from the service from which they are recruited. While the intervention to be used in the feasibility trial is not yet confirmed, we anticipate it will be brief (around 1-4 sessions) and will draw on the information motivation and behaviour skills model of health behaviour change:
1.1. Understanding BBV injecting and sexual transmission risks
1.2. Motivation for change
1.3. Skills building for safer injecting and sexual practices
1.4. Negotiating safer injecting and sexual practices
2. Control arm:
Participants randomly allocated to the control arm will be given an information leaflet on reducing the transmission of blood borne viruses by a drugs worker. They will also receive treatment as usual from the service from which they are recruited.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The proposed study will examine feasibility and is not powered to determine effect. Differences in number of risk events in past month will be assessed pre, end and 1 month post intervention using intention-to-treat analysis. The Blood Borne Virus Transmission Risk Assessment Questionnaire (TRAQ) will assess the frequency with which PWID have participated in specific injecting, sexual and other risk-practices in the previous month that may expose them to blood-borne viruses. The REDUCE questionnaire on Hepatitis C transmission knowledge and The brief HIV-Knowledge Questionnaire will measure transmission knowledge.
Secondary outcome measures
Quality of life will be measured using EQ-5D
Overall trial start date
01/10/2015
Overall trial end date
31/05/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. PWID are aged 18 and older attending NHS and third sector community addiction and harm reduction clinics and needle exchange programmes (static and mobile)
2. Who have injected drugs at least once in the past 4 weeks
3. Who plan to stay in the area for the next 3 months
4. Who are able to complete the assessment (alone or with help of researcher) and communicate in a group intervention in English.
PWID are not routinely screened for BBV at drug treatment services & therefore do not always know their BBV status. As the focus of the proposed psychosocial intervention will be to increase knowledge about transmission/ reinfection & promote motivation/skills for safer injecting & sex practices, the intervention content will be the same regardless of BBV status.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128 PWID for feasibility trial
Participant exclusion criteria
PWID who are too intoxicated or in withdrawal to give informed consent.
Recruitment start date
01/10/2015
Recruitment end date
31/05/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kings College London
London
SE5 8BB
United Kingdom
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28320406
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29208190