Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04159545 |
| Other study ID # |
2-39-19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2019 |
| Est. completion date |
May 31, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
University of Dundee |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), if left untreated it
can lead to chronic liver disease, cirrhosis and cancer. HCV is a blood borne virus, the key
risk group for HCV infection are those who currently inject drugs, or have done in the past.
For many years the treatment of chronic HCV infection was based on therapies that had
significant side effects, long treatment period and were between 50-70% effective, this
impacted on patient acceptability and compliance. However, for those completing the treatment
and undergoing this "personal trial" literature describes the transformative experience of
HCV cure and how people took steps towards a "normal life" moving beyond substance use.
Recent advances in Direct-Acting Antiviral (DAA) medicines available to cure HCV have
transformed treatment with shorter treatment periods, few side effects, ease of
administration and improved efficacy. However, there is a potential paradox, in that the
DAA-based regimes provide a reliable cure, for a large majority of patients, with a
relatively small treatment burden, but may not be a "personal trial" and may have a lesser
impact on rehabilitation and recovery from substance use.
The success of attempts of the group cured of HCV with DAAs, to progress down a recovery
pathway and to resume activities thought of as being part of normal citizenship, are
therefore unclear.
This study will examine the types of activities that people cured of HCV undertake and the
success of their recovery pathway, post-treatment with DAAs over a two year follow-up period.
Description:
This study uses an ethnographic case study approach using mixed methods to describe the
journey towards citizenship of people cured of HCV with DAAs through their recovery from
substance use. Qualitative and quantitative data will be collected from participants in a
series of three interviews over the course of a two year period.
Qualitative data collated will describe the views and experiences of those in this specific
social situation and examine how this narrative evolves.
Quantitative data (Substance use (WHO ASSIST 3.0 Q2), Social Identity mapping, Short
Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS), Participant capture form data - financial
inclusion, household income and employment data) will be collected to demonstrate a physical
quantifiable change to allow for data triangulation to describe the phenomenon under study.
The ethnographic case study will be delivered through the immersion of a qualitative
researcher within the context of a community centre providing care for people who use drugs.
Case Setting
The Cairn Centre in Dundee is a partnership with Hillcrest, NHS Tayside, Dundee City Council
and other voluntary sector partners. The centre is placed at the heart of the community in
Dundee City and acts as an interface between people who inject drugs and the agencies that
are established to support them. The Cairn centre offers a drop-in recovery cafe run by
volunteers, providing a warm and welcoming environment for anyone interested in recovery. The
atmosphere allows informal support for people with their recovery and a chance to socialise
and meet other people in recovery. The centre also provides a backdrop for a variety of other
sources of support available including drug and alcohol treatment, Blood Borne Virus testing
and treatment, dentistry, ophthalmology, sexual health service, Keep Well Health checks,
welfare and legal advice, housing and homeless advice, families mutual aid, overdose
prevention training and naloxone as well as a variety of recovery groups helping people
develop new skills and interests.
The Cairn centre is Dundee's busiest injecting equipment provision (IEP) provider and
provides support and advice to active drug users as well as those in more advanced stages of
recovery.
This study will also utilise other locations to capture the views of others who may not visit
this setting. Utilising other locations adds to the validity of the study to capture the
universe of experiences of those with problematic substance use treated with direct-acting
antivirals and recognises that as people progress along a recovery journey their social
setting may change. Other locations include drop-in services, hubs and Recovery Cafes run by
third sector partners within Dundee, Angus and Perth & Kinross Health and Social Care
Partnerships. NHS Tayside locations that provide drug services and community pharmacy
contractors will also be utilised as locations.
Ethnographic case study Development of semi-structured interviews. An inductive approach will
be taken to develop semi-structured interviews. A cohort of participants will be interviewed
using broad, open interviews to explore the universe of experiences of this participant group
in relation to substance use, testing and/or treatment of hepatitis C with direct
acting-antivirals and life circumstances.
Themes will be explored until there is a consensus and no new emerging themes are identified.
Explicit and Implicit emergent themes from the inductive interviews will be explored and
evaluated by the researcher with triangulation within the research team alongside the
literature and evidence of the theoretical frameworks "Recovery Capital" and "Identity
Theories" to generate qualitative research questions. The qualitative research questions will
be further explored by developing semi-structured interviews around the themes identified.
Researcher observation field notes The researcher will record participant observations during
the interviews to provide rich verbatim descriptions of the specific situations, events and
behaviours of the participants.
Thematic Analysis Thematic analysis will be used to identify, analyse and report patterns
(themes) within the data using the computer assisted qualitative data analysis package NVivo.
The coding strategy will be open and emergent to allow new and emerging themes to be captured
accurately.
Researcher triangulation of themes and coding strategy will be used to validate themes and
minimise researcher bias. Cohen's Kappa coefficient will be reported at each stage to assess
interpreter agreement.
After each interview and observation stage themes identified by the research team will be
validated with participants to check the interpretation captured both implicit and explicit
meanings of the pervious interview. This will be carried out at the end of the interview to
minimise recall bias and influence of current interview stage answers.
The narrative and connecting analysis completed after the second interview stage will allow
for a theory to be generated describing an authentic and accurate narrative of the personal
value of cure of Hepatitis C. This theory will be tested at the final interview stage to
allow for causal validation using the approaches of modus operandi and searching for negative
cases.
Quantitative data collection Participant Capture Form Participant data will be collected at
baseline, 2nd visit and 3rd visit to record age, gender, ethnic background, financial
inclusion, household income and employment data, current and/or previous treatment for
problematic substance use and any previous history of hepatitis C infection. Baseline is
defined in this study as first visit after consent is given. Questions that cannot change
will only be asked at baseline, for example ethnic origin.
Participants will be asked questions to identify demographics to ensure participants are
purposively selected to describe the universe of themes and experiences.
The questions included are part of the Scottish Survey Core Questions and are recommended for
use in other surveys due to:
- Comparability across surveys is improved
- Thoroughly tested questions to provide confidence that participants understand what is
being asked
- Questions have been widely consulted on to reduce risk of offence when asking questions
about a sensitive subject The researcher will assist the participant to complete these
questions. Participants may decline to answer these questions if they find the subject
difficult or embarrassing, in this event this will be recorded.
World Health Organisation Alcohol, Smoking and Substance Involvement Screening Test (WHO
ASSIST 3.0) The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was
developed for the World Health Organization (WHO) to detect and manage substance use and
related problems in primary and general medical care settings. This study will utilise
Question 2 of the WHO ASSIST screening tool to provide a measure of substances used and
frequency within the last three months. The question uses a 5 point Likert scale to provide a
quantitative measure of substance use at that point in time. The participant will complete
this form with the assistance of the researcher if required.
Social Identity Map- Ascertaining identity resources (SIM - AIRing) The participants will be
asked to place their social networks on a mapping tool that will provide a graphic
representation of the social network at that point in time. The participants name will not be
recorded on the map, only the participant ID number. The map will demonstrate the number of
social contacts within the network, a measure of the relationship (inner circle, outer circle
and influence) and the substance use status of the members of the network. Participants will
be asked to assign pseudo identities for their social network members. The pseudo identity is
known only to the participant and will be insufficient for the researcher to identify an
actual person.
The participant will rate the importance of their social network members (indicated by
placing them in the inner or outer circle) and indicate their status as user, non-user or in
recovery. Social contact pseudo identities will be assigned coloured dots to indicate their
status: red for active user, green for non-user and blue for individuals in recovery. This
tool provides a quantitative measure of social network and will be mapped at each interview
stage so that longitudinal insights into the change in social influences may be clearly
described.
The researcher will assist the participant to complete this map.
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) Participants will be asked to
complete the self-reported short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) with
assistance from the researcher if required. The measure is a list of 7 positive mental health
statements with 5 response categories assigned scores and the total scores calculated.
Movements in the total wellbeing score have been valuated using the wellbeing valuation
method and represent the additional money the average individual would need to improve their
wellbeing, which is the same as the improvement in their SWEMWBS score. This measurement can
then be used to calculate a social value impact.
Data collection A baseline measure of patient demographics will be recorded at the first
interview stage and at each interview to describe any changes over time.
Participants will be followed over a 2 year interval with an aim of 3 contacts over that
period. Interviews at baseline and followed up between 6-18 months after baseline and at the
end point over a 2 year period. Qualitative and Quantitative data will be collected and
analysed at each interview stage.
A narrative of the final destinations achieved for those cured of HCV using DAAs will be
reported with a description of how this cure changes participant's perspectives on their
place in society, a personal value of a cure and changes in social network structures.
