Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting (SHARP-P)
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|ClinicalTrials.gov Identifier: NCT03740906|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 21, 2019
SHARP-P is an observational cohort study investigating the effect of direct-acting antiviral (DAA) therapy and reinfection in people with chronic hepatitis C virus (HCV) and recent injecting drug use. A prospective, observational cohort design will be used to enrol patients from correctional centres in New South Wales, Australia.
Participants will be prescribed a direct-acting HCV medication as per the standard of care. The on treatment phase will vary dependent on the type of a direct-acting antiviral prescribed as per the standard of care. Once patients have completed their treatment course they will be followed up every 3 months for up to 3 years following the end of treatment phase.
The study will aim to evaluate the incidence of HCV reinfection following successful DAA treatment over the three years of follow up. The study will also evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) with direct-acting anti-viral HCV therapy.
|Condition or disease|
|Hepatitis C, Chronic|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting (The SHARP-P Study)|
|Actual Study Start Date :||September 6, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- To evaluate the incidence of HCV reinfection following successful DAA therapy among people with chronic HCV infection and recent injecting drug use in the prison setting. [ Time Frame: 3 years ]
- To evaluate the proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following DAA HCV therapy among PWID with chronic HCV infection and recent injecting drug use [ Time Frame: 2.5 years ]
- To evaluate the proportion of participants who complete treatment [ Time Frame: 3 years ]
- To evaluate the proportion of participants with undetectable HCV RNA at the end of treatment [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
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): NCT03740906
|Contact: Pip Marks||+61 2 9385 firstname.lastname@example.org|
|Contact: Andrew Lloydemail@example.com|
|Australia, New South Wales|
|NSW Correctional Centres||Recruiting|
|Sydney, New South Wales, Australia|
|Contact: Jodi Van Dyk firstname.lastname@example.org|
|Principal Investigator:||Andrew Lloyd||Kirby Institute|