Status:
COMPLETED
Prisons Evaluation of a One-stop-shop InterVentiOn
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
Justice Health & Forensic Mental Health Network NSW Australia
Conditions:
Hepatitis C
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
A prospective historically controlled study to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, non-invasive liver fibrosis assessment, fast-tracked direct...
Eligibility Criteria
Inclusion
- Inclusion criteria
- has provided written, informed consent to participate;
- is male and ≥18 years of age on enrolment;
- has been incarcerated within the last six weeks;
- is HCV DAA treatment naïve;
- is able and willing to provide informed consent and abide by the requirements of the study.
- For HCV RNA positive participants commencing treatment:
- if HIV-1 infected must also meet the following criteria:
- HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load; and
- be on HIV antiretroviral therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the selected DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/ )
- Exclusion criteria
- For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
- untreated HIV co-infection;
- chronic HBV co-infection;
- any clinically significant condition, history or concomitant medication known to contraindicate DAA therapy or would not be suitable for management within a prison-based treatment setting;
- is unable to gain an accurate reading on the fibroscan or the result is invalid;
- known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (\> 12.5 Kpa).
Exclusion
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2021
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT04809246
Start Date
October 31 2019
End Date
September 10 2021
Last Update
January 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mid North Coast Correctional Centre
Kempsey, New South Wales, Australia, 2441