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Prisons Evaluation of a One-stop-shop InterVentiOn (PIVOT)

Primary Purpose

Hepatitis C

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

'One-stop-shop' hepatitis clinic

About this trial

This is an interventional health services research trial for Hepatitis C focused on measuring Hepatitis C, Public Health, Health Service, Prisons

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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:
1. 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
2. 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).

Sites / Locations

Mid North Coast Correctional Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

'One-stop-shop' intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The proportion of people tested for HCV infection at 12 weeks from enrolment

The proportion of participants who complete DAA therapy in prison

The proportion of people who have an end of treatment response

The proportion of people who have an HCV treatment response (sustained virological response)

The time taken from testing to each step in the care cascade

The proportion of people lost to follow-up

The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)

The proportion of people reinfected at SVR12

The proportion of people reporting injecting risk behaviours (at ETR and SVR12)

The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)

Full Information

NCT ID

NCT04809246

First Posted

February 2, 2021

Last Updated

January 12, 2022

Sponsor

Kirby Institute

Collaborators

Justice Health & Forensic Mental Health Network NSW Australia

1. Study Identification

Unique Protocol Identification Number

NCT04809246

Brief Title

Prisons Evaluation of a One-stop-shop InterVentiOn

Acronym

PIVOT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

October 31, 2019 (Actual)

Primary Completion Date

April 23, 2021 (Actual)

Study Completion Date

September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kirby Institute

Collaborators

Justice Health & Forensic Mental Health Network NSW Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C, Public Health, Health Service, Prisons

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

541 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

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

Arm Title

'One-stop-shop' intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

'One-stop-shop' hepatitis clinic

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks from enrolment

Secondary Outcome Measure Information:

Title

The proportion of people tested for HCV infection at 12 weeks from enrolment

Time Frame

12 weeks from enrolment

Title

The proportion of participants who complete DAA therapy in prison

Time Frame

End of Treatment (8 weeks from treatment initiation)

Title

The proportion of people who have an end of treatment response

Time Frame

End of Treatment (8 weeks from treatment initiation)

Title

The proportion of people who have an HCV treatment response (sustained virological response)

Time Frame

Sustained virological response at 12 weeks post treatment completion

Title

The time taken from testing to each step in the care cascade

Time Frame

Varying, up to 9 months post-enrolment.

Title

The proportion of people lost to follow-up

Time Frame

Varying, up to end of study (estimated to be 12 months from study commencement)

Title

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)

Title

The proportion of people reinfected at SVR12

Time Frame

Varying, up to 9 months post-enrolment.

Title

The proportion of people reporting injecting risk behaviours (at ETR and SVR12)

Time Frame

Varying, up to 9 months post-enrolment.

Title

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)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Lloyd, Prof

Organizational Affiliation

Kirby Institute, University NSW

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mid North Coast Correctional Centre

City

Kempsey

State/Province

New South Wales

ZIP/Postal Code

2441

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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)

IPD Sharing Time Frame

Data may be available immediately following publication for 7 years, no end date determined, upon request to the researchers.

IPD Sharing Access Criteria

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.

Learn more about this trial

Prisons Evaluation of a One-stop-shop InterVentiOn

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