Evaluation of Point Of Care Hepatitis C testing and subsequent treatment uptake in injecting drug users visiting a medically Supervised Injecting Room – a pilot study (EPOCH-SIR)

Gastroenterology Department, St Vincent's Hospital Melbourne0 个研究点目标入组 1,500 人开始时间: 2020年4月29日最近更新: 2023年9月18日

适应症

试验速览

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•Aged greater than or equal to 18 years;
•- Present to the medically supervised injecting room during the recruitment phase of the study;
•- Able to provide written informed consent;
•- Consent to provide full name, contact details and Medicare number;
•- Consent to multiple visits and to completion of questionnaires;
•- Consent to blood sample for storage at pre-specified time points during the study;
•- Not currently engaged in care for treatment of hepatitis C infection, hepatitis B or HIV;
•- Fulfills study criteria for hepatitis C diagnosis to initiate treatment.

•- Pregnant or breastfeeding at time of commencement of hepatitis C antiviral treatment;
•- Clinical evidence of decompensated cirrhosis;
•- Diagnosed and/or undergoing treatment for hepatocellular carcinoma;
•- Awaiting liver transplantation;
•- Currently engaged in care for treatment of hepatitis C infection, hepatitis B infection or HIV;
•- Unable or unwilling to present to pick up ongoing DAA supply for treatment (four weekly basis);
•- Receiving medications which are contra-indicated to co-administration of direct acting antiviral's or at risk of significant drug-drug interactions;
•- Clients who are first time presenters or users of the medically supervised injecting room
•- Clients who receive a clinical intervention for overdose whilst using the supervised injecting drug room after initially consenting to participate;
•- Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study’s results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant.

发起方

Gastroenterology Department, St Vincent's Hospital Melbourne