An interventional study of 'One-stop-shop' hepatitis clinic in Hepatitis C, sponsored by Kirby Institute. Completed at 1 site in Australia. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-14.
Sponsored by Kirby Institute · Not applicable, Interventional, and Health services research
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-acting antiviral (DAA) prescription, and linkage to hepatitis care (a 'one-stop-shop' intervention), on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 541 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion criteria
For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
The first group (n=240) of participants enrolled in the study will be assigned to the control period to receive the standard of care.
Following the control period, the second group (n=300) of participants enrolled in the study will be assigned to the intervention period to receive the 'one-stop-shop' intervention.
Other: 'One-stop-shop' hepatitis clinic
Establishment of a 'one-stop-shop' hepatitis clinic, integrating point-of-care HCV RNA testing, followed by clinical assessment, non-invasive liver fibrosis assessment by fibro-elastography (Fibroscan), and early DAA prescription (for those with chronic HCV) followed by linkage to ongoing hepatitis care, all in the same 60-minute visit.
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
Time frame: 12 weeks from enrolment
The proportion of people tested for HCV infection at 12 weeks from enrolment
Time frame: 12 weeks from enrolment
The proportion of participants who complete DAA therapy in prison
Time frame: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an end of treatment response
Time frame: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an HCV treatment response (sustained virological response)
Time frame: Sustained virological response at 12 weeks post treatment completion
The time taken from testing to each step in the care cascade
Time frame: Varying, up to 9 months post-enrolment.
The proportion of people lost to follow-up
Time frame: Varying, up to end of study (estimated to be 12 months from study commencement)
The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)
Time frame: Varying, up to end of subject enrolment (estimated to be 12 months from study commencement)
The proportion of people reinfected at SVR12
Time frame: Varying, up to 9 months post-enrolment.
The proportion of people reporting injecting risk behaviours (at ETR and SVR12)
Time frame: Varying, up to 9 months post-enrolment.
The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)
Time frame: End of study (estimated to be 12 months from study commencement)
Plan to share: Yes — Data may be available immediately following publication for 7 years, no end date determined, upon request to the researchers. Data may be available to researchers on a case-by-case basis at the discretion of Principal Investigator. Data may be available to researchers upon request for conducting IPD meta-analyses (separate ethics approval required). Access to data is subject to approvals by Principal Investigator (a.lloyd@unsw.edu.au)
Supporting information: Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kirby Institute