PIVOT: Prisons Evaluation of a One-stop-shop InterVentiOn

Sponsor

Kirby Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04809246

Collaborator

Justice Health & Forensic Mental Health Network NSW Australia (Other)

541

Enrollment

Location

Arms

22.3

Actual Duration (Months)

24.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Other: 'One-stop-shop' hepatitis clinic	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

541 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Prisons Evaluation of a One-stop-shop InterVentiOn to Scale-up Hepatitis C Testing and Treatment (PIVOT)

Actual Study Start Date :

Oct 31, 2019

Actual Primary Completion Date :

Apr 23, 2021

Actual Study Completion Date :

Sep 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of care The first group (n=240) of participants enrolled in the study will be assigned to the control period to receive the standard of care.
Experimental: 'One-stop-shop' intervention 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.

Arm

Intervention/Treatment

No Intervention: Standard of care

The first group (n=240) of participants enrolled in the study will be assigned to the control period to receive the standard of care.

Experimental: 'One-stop-shop' intervention

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.

Outcome Measures

Primary Outcome Measures

The proportion of people who have initiated DAA therapy within 12 weeks from enrolment [12 weeks from enrolment]

Secondary Outcome Measures

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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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).