Future Destinations: Journeys Towards Citizenship

NCT04159545 | Completed DMC

• 1 other identifier: 2-39-19
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C; Drug Use

Outcome Measures

Primary Outcomes (1)

• Non-clinical future destinations achieved

  The views, meaning and value of cure for individuals cured of HCV with DAA's and the non-clinical future destinations achieved.

  2 years

Secondary Outcomes (3)

• Measurement in drug taking behaviours of drugs used and frequency

  2 years

• Map of social network with a measure of individuals with problematic substance use, those in recovery and those with no history of problematic substance use. Measuring changes over the time frame.

  2 years

• Measure, understand and communicate the economic and social value of the non-clinical outcomes of potential changes of those cured of HCV with DAAs

  2 years

Study Arms (2)

Participants treated with DAAs

Participants identified through the standard pathway of care as receiving Direct-Acting Antiviral (DAA) drugs to treat chronic hepatitis C with a history of problematic substance use. Participants will be interviewed on 3 occasions over the course of 2 years. Participants views, meanings and value of cure will be explored through semi-structured interviews. Participants will also complete quantitative questionnaires to measure changes in drug taking behaviours of drugs used and frequency (WHO ASSIST 3.0 Q2), Map social networks (SIM-AIRing), Measure wellbeing in terms of economic and social value (Short Warwick- Edinburgh Mental Wellbeing Scale (SWEMWBS) and financial inclusion, household income and employment data).

Other: Qualitative and quantitative interviews

Control Group

Participants identified through the standard pathway of care as having HCV positive antibodies who spontaneously clear the infection. Participants will be interviewed on 3 occasions over the course of 2 years. Participants views, meanings and value of cure will be explored through semi-structured interviews. Participants will also complete quantitative questionnaires to measure changes in drug taking behaviours of drugs used and frequency (WHO ASSIST 3.0 Q2), Map social networks (SIM-AIRing), Measure wellbeing in terms of economic and social value (Short Warwick- Edinburgh Mental Wellbeing Scale (SWEMWBS) and financial inclusion, household income and employment data).

Other: Qualitative and quantitative interviews

Interventions

Qualitative and quantitative interviews OTHER

Qualitative semi-structured interviews and quantitative questionnaires

Control Group; Participants treated with DAAs

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with a history of problematic substance use and chronic hepatitis C infection prior or after treatment with DAAs or a control group with positive HCV antibodies who spontaneously clear the virus identified during standard pathway of care.

You may qualify if:

• Adults with a history of problematic substance use with chronic HCV infection who are or have been treated with DAAs.
• Adults who have a history of problematic substance use and positive HCV antibodies who spontaneously clear the infection (control group)
• People of any ethnic origin who are able to speak English and are willing to talk about and reflect on their experiences with the phenomenon under study.
• Participants willing to have the semi-structured interviews audio recorded.

You may not qualify if:

• Participants with no history of problematic substance use.
• Participants who are not willing to consent to the study
• Participants who do not speak English.
• Females who report being pregnant at the beginning if the study will be excluded.
• Females who become pregnant during the study period will be excluded, however data obtained prior to the pregnancy may still be included.

Sponsors & Collaborators

• University of Dundee: lead
• NHS Tayside: collaborator

Study Sites (1)

Cairn Centre

Dundee, Tayside, DD1 1NA, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Sarah R Donaldson, MPharmS

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: December 15, 2019
• Primary Completion: June 1, 2022
• Study Completion: May 31, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)