Prisons Evaluation of a One-stop-shop InterVentiOn

NCT04809246 | Completed

• 1 other identifier: VISP0105
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; Public Health; Health Service; Prisons

Outcome Measures

Primary Outcomes (1)

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

  12 weeks from enrolment

Secondary Outcomes (10)

• 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.

Study Arms (2)

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.

Other: 'One-stop-shop' hepatitis clinic

Interventions

'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.

'One-stop-shop' intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/ )

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kirby Institute: lead
• Justice Health & Forensic Mental Health Network NSW Australia: collaborator

Study Sites (1)

Mid North Coast Correctional Centre

Kempsey, New South Wales, 2441, Australia

Location

Related Publications (2)

• 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.

  PMID: 37116714 DERIVED

• 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.

  PMID: 36683132 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Andrew Lloyd, Prof

  Kirby Institute, University NSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 22, 2021
• Study Start: October 31, 2019
• Primary Completion: April 23, 2021
• Study Completion: September 10, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data may be available immediately following publication for 7 years, no end date determined, upon request to the researchers.
• 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.

Locations

AU (1)