Extract

Background and study aims Hepatitis C virus (HCV) is a blood-borne infection that can seriously damage the liver. It mainly spreads through intravenous drug use particularly, sharing needles, and those that are already infected are at considerable risk of transmitting the virus to their sexual partners. There are good effective treatments for HCV. However treatment success is dependent on giving the correct treatment, intake of medicines regularly and with careful supervision. Active drug users are not currently offered HCV eradication treatment because they live a very chaotic lifestyle which makes it difficult for them to engage with services and to comply with the strict treatment routines and required safety follow up. This study aims to offer treatment to a group of drug users and to find out whether intensive support and regular follow up by dedicated research nurses plus giving various incentives has improved compliance with treatment and drug safety monitoring, thereby resulting in them clearing the HCV Who can participate? Active IV drug users, who have HCV testing that shows they are HCV positive will be asked to participate in this study. What does the study involve? A note of their medical history, drug use history, vital signs such as weight, blood pressure, pulse and injection sites will be recorded at the first screening visit. Depending on the strain of Hep C they are infected with they will enter one of two treatment regimes, which follows standard clinical practice, at the second visit. They will be issued with a mobile phone, asked to complete a short quality of life questionnaire, have safety blood tests done and have a urine drug screen. They may be prescribed methadone, and will be issued with a voucher for attending and some protein drinks. They will return weekly to see the study nurse for up to 24 weeks and will have urine drug screening, blood tests to check their liver and kidney function, their full blood count and viral load measured weekly for the first four weeks then fortnightly thereafter. It is to be noted that this is standard NHS clinical practice. Urine drug screening and assessment of any side effects will be noted weekly up to week 24, illicit drug use will be charted and they will be given weekly vouchers of between £5- £10, have their next weeks supply of drug therapy issued and be given a weeks supply of protein drinks. Questionnaires will be collected at their first drug administration and at weeks 6, 12 and 24. At 3 and 6 months post treatment, they will be seen by the nurse and checked for any side effects and be given their final lot of vouchers. They will complete questionnaires at 3, 6, 18, 30 and 42 month post treatment if still contactable. All participants will receive Naloxone (an anti dote to heroin) training 3 times in this study (twice more than routine practice). IV drug users normally inject in company and it is vitally important they have the skills to provide an antidote if one of their peers overdoses, prior to the arrival of paramedics, as there is a serious risk of death from overdosing on heroin. What are the possible benefits and risks of participating? Possible benefits are that participants will be monitored closely during the study and will be seen by a specialist nurse at each study visits. Accessing specialist services may be an encouragement to reduce their high risk behaviour. The study may not immediately benefit all participants but if the results of the study are positive this may change the practice of managing patients with Hepatitis C who continue to inject drugs and potentially will have a great impact on other such patients in the future. There are no known risks from taking part in the study though the risks of the standard care treatment regimes for HCV infection will be explained thoroughly by the study doctors. Where is the study run from? The study is run from the Needle Exchange Centres in Tayside, mainly from the Cairn Centre in Dundee, UK. When is the study starting and how long is it expected to run for? November 2012 to February 2017 Who is funding the study? Public Health Team, Department of Health, Scottish Government (UK) Who is the main contact? Steve McSwiggan [email protected]

Inclusion criteria

• Hepatitis C infection in active intravenous drug users

Links

• ictrp
• isrctn