Prisons Evaluation of a One-stop-shop InterVentiOn

Hepatitis C Clinical Trial

— PIVOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809246
• Other study ID #: VISP0105
• Status: Completed
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: September 10, 2021

Study information

• Verified date: January 2022
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: September 10, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

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.

Locations

Country	Name	City	State
Australia	Mid North Coast Correctional Centre	Kempsey	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	Justice Health & Forensic Mental Health Network NSW Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of people who have initiated DAA therapy within 12 weeks from enrolment		12 weeks from enrolment
Secondary	The proportion of people tested for HCV infection at 12 weeks from enrolment		12 weeks from enrolment
Secondary	The proportion of participants who complete DAA therapy in prison		End of Treatment (8 weeks from treatment initiation)
Secondary	The proportion of people who have an end of treatment response		End of Treatment (8 weeks from treatment initiation)
Secondary	The proportion of people who have an HCV treatment response (sustained virological response)		Sustained virological response at 12 weeks post treatment completion
Secondary	The time taken from testing to each step in the care cascade		Varying, up to 9 months post-enrolment.
Secondary	The proportion of people lost to follow-up		Varying, up to end of study (estimated to be 12 months from study commencement)
Secondary	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)
Secondary	The proportion of people reinfected at SVR12		Varying, up to 9 months post-enrolment.
Secondary	The proportion of people reporting injecting risk behaviours (at ETR and SVR12)		Varying, up to 9 months post-enrolment.
Secondary	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)