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Future Destinations: Journeys Towards Citizenship

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ClinicalTrials.gov Identifier: NCT04159545
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
John Dillon, University of Dundee

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.


Condition or disease Intervention/treatment
Hepatitis C Drug Use Other: Qualitative and quantitative interviews

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Journeys Towards Citizenship: How People Cured of Hepatitis C (HCV) Using Direct-Acting Antiviral (DAA) Drugs Progress in a New HCV-free World. Future Destinations
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Qualitative semi-structured interviews and quantitative questionnaires

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
Qualitative semi-structured interviews and quantitative questionnaires




Primary Outcome Measures :
  1. Non-clinical future destinations achieved [ Time Frame: 2 years ]
    The views, meaning and value of cure for individuals cured of HCV with DAA's and the non-clinical future destinations achieved.


Secondary Outcome Measures :
  1. Measurement in drug taking behaviours of drugs used and frequency [ Time Frame: 2 years ]
    WHO ASSIST 3.0 Q2 questionnaire

  2. 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. [ Time Frame: 2 years ]
    Social Identity mapping - Ascertaining Identity Resources (SIM-AIRing)

  3. Measure, understand and communicate the economic and social value of the non-clinical outcomes of potential changes of those cured of HCV with DAAs [ Time Frame: 2 years ]
    Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) and financial inclusion, household income and employment patient demographic capture form



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159545


Contacts
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Contact: Sarah R Donaldson, MPharmS 07967323195 sarahrdonaldson@nhs.net
Contact: Andrew Radley, MPhil 01382 425681 andrew.radley@nhs.net

Locations
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United Kingdom
Cairn Centre Recruiting
Dundee, Tayside, United Kingdom, DD1 1NA
Contact: Sarah R Donaldson, MRPharm(s)    07709357176    sarahrdonaldson@nhs.net   
Principal Investigator: Sarah R Donaldson, MRPharm(s)         
Sponsors and Collaborators
University of Dundee
NHS Tayside
Investigators
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Principal Investigator: Sarah R Donaldson, MPharmS University of Dundee
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Responsible Party: John Dillon, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT04159545    
Other Study ID Numbers: 2-39-19
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections