Prisons Evaluation of a One-stop-shop InterVentiOn

Not Applicable

Completed

• Conditions: Hepatitis C
• Interventions: Other: 'One-stop-shop' hepatitis clinic

• Registration Number: NCT04809246
• Lead Sponsor: Kirby Institute

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-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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-31
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Primary Completion: 2021-04-23
• Study Completion: 2021-09-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 541

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'One-stop-shop' intervention	'One-stop-shop' hepatitis clinic	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.

Primary Outcome Measures

Name	Time	Method
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment	12 weeks from enrolment

Secondary Outcome Measures

Name	Time	Method
The proportion of people who have an end of treatment response	End of Treatment (8 weeks from treatment initiation)
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 lost to follow-up	Varying, up to end of study (estimated to be 12 months from study commencement)
The proportion of participants who complete DAA therapy in prison	End of Treatment (8 weeks from treatment initiation)
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)
The proportion of people tested for HCV infection at 12 weeks from enrolment	12 weeks from enrolment
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 reporting injecting risk behaviours (at ETR and SVR12)	Varying, up to 9 months post-enrolment.

Trial Locations

Locations (1)

Mid North Coast Correctional Centre; 🇦🇺 Kempsey, New South Wales, Australia