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| Name | Class |
|---|---|
| Justice Health & Forensic Mental Health Network NSW Australia | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | The first group (n=240) of participants enrolled in the study will be assigned to the control period to receive the standard of care. | |
| 'One-stop-shop' intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'One-stop-shop' hepatitis clinic | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of people who have initiated DAA therapy within 12 weeks from enrolment | 12 weeks from enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of people tested for HCV infection at 12 weeks from enrolment | 12 weeks from enrolment | |
| The proportion of participants who complete DAA therapy in prison | End of Treatment (8 weeks from treatment initiation) |
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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:
Exclusion criteria
For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Lloyd, Prof | Kirby Institute, University NSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid North Coast Correctional Centre | Kempsey | New South Wales | 2441 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37116714 | Derived | Sheehan Y, Cunningham EB, Cochrane A, Byrne M, Brown T, McGrath C, Lafferty L, Tedla N, Dore GJ, Lloyd AR, Grebely J. A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study. J Hepatol. 2023 Sep;79(3):635-644. doi: 10.1016/j.jhep.2023.04.019. Epub 2023 Apr 26. | |
| 36683132 |
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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)
Data may be available immediately following publication for 7 years, no end date determined, upon request to the researchers.
Access to data is subject to approvals by Principal Investigator (a.lloyd@unsw.edu.au). A link to the report will be provided upon publication.
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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This study will be conducted as a prospective historically controlled study with a primary objective of assessing the effect of an intervention integrating point-of-care HCV RNA testing, non-invasive liver fibrosis assessment, fast-tracked DAA therapy, 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.
All people who are newly incarcerated (in the previous six weeks) will be offered participation. The first 240 individuals will be enrolled into a control period to receive HCV testing and treatment via the standard of care with the current health service model. After the control period, the next 300 individuals will be enrolled in the intervention period to receive HCV testing and treatment via the 'one-stop-shop' intervention.
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|
| The proportion of people who have an end of treatment response | End of Treatment (8 weeks from treatment initiation) |
| The proportion of people who have an HCV treatment response (sustained virological response) | Sustained virological response at 12 weeks post treatment completion |
| The time taken from testing to each step in the care cascade | Varying, up to 9 months post-enrolment. |
| The proportion of people lost to follow-up | 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) | Varying, up to end of subject enrolment (estimated to be 12 months from study commencement) |
| The proportion of people reinfected at SVR12 | Varying, up to 9 months post-enrolment. |
| The proportion of people reporting injecting risk behaviours (at ETR and SVR12) | 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) | End of study (estimated to be 12 months from study commencement) |
| Lafferty L, Sheehan Y, Cochrane A, Grebely J, Lloyd AR, Treloar C. Reducing barriers to the hepatitis C care cascade in prison via point-of-care RNA testing: a qualitative exploration of men in prison using an integrated framework. Addiction. 2023 Jun;118(6):1153-1160. doi: 10.1111/add.16137. Epub 2023 Feb 12. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |