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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Other: 'One-stop-shop' hepatitis clinic

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kempsey, New South Wales, Australia, 2441
      • Mid North Coast Correctional Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria

1. has provided written, informed consent to participate;
2. is male and ≥18 years of age on enrolment;
3. has been incarcerated within the last six weeks;
4. is HCV DAA treatment naïve;

5. is able and willing to provide informed consent and abide by the requirements of the study.

   For HCV RNA positive participants commencing treatment:

6. 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:

1. untreated HIV co-infection;
2. chronic HBV co-infection;
3. 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;
4. is unable to gain an accurate reading on the fibroscan or the result is invalid;
5. known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (> 12.5 Kpa).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment	12 weeks from enrolment

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: Justice Health & Forensic Mental Health Network NSW Australia
• Investigators: Principal Investigator: Andrew Lloyd, Prof, Kirby Institute, University NSW

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2019
• Primary Completion (ACTUAL): April 23, 2021
• Study Completion (ACTUAL): September 10, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (ACTUAL): March 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Hepatitis C; Public Health; Prisons; Health Service
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: VISP0105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No