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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Non-clinical future destinations achieved
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Non-clinical future destinations achieved
时间窗: 2 years
The views, meaning and value of cure for individuals cured of HCV with DAA's and the non-clinical future destinations achieved.
次要结局
- 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)
- Measurement in drug taking behaviours of drugs used and frequency(2 years)
研究者
John Dillon
Professor
University of Dundee