Prisons Evaluation of a One-stop-shop InterVentiOn

NCT ID: NCT04809246

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 541 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-09-10

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

'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.

Group Type: EXPERIMENTAL

'One-stop-shop' hepatitis clinic

Intervention Type: 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.

Interventions

'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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Justice Health & Forensic Mental Health Network NSW Australia

UNKNOWN

Sponsor Role: collaborator

Kirby Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Lloyd, Prof

Role: PRINCIPAL_INVESTIGATOR

Kirby Institute, University NSW

Locations

Mid North Coast Correctional Centre

Kempsey, New South Wales, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 37116714 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36683132 (View on PubMed)

Other Identifiers

VISP0105

Identifier Type: -

Identifier Source: org_study_id