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

Kirby Institute

Status: Completed

Conditions: Hepatitis C

Treatments: Other: 'One-stop-shop' hepatitis clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT04809246

VISP0105

Details and patient eligibility

About

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.

Enrollment: 541 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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541 participants in 2 patient groups

Standard of care

No Intervention group

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.

'One-stop-shop' intervention

Experimental group

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.

Treatment:

Other: 'One-stop-shop' hepatitis clinic