Clinical trial NCT04809246: Prisons Evaluation of a One-stop-shop InterVentiOn
Official title: Prisons Evaluation of a One-stop-shop InterVentiOn to Scale-up Hepatitis C Testing and Treatment (PIVOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Hepatitis C
Public Health
Health Service
Prisons
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: Justice Health & Forensic Mental Health Network NSW Australia
First posted: 2021-03-22
Enrollment: 541
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
timeFrame: 12 weeks from enrolment
Secondary outcomes:
measure: The proportion of people tested for HCV infection at 12 weeks from enrolment
timeFrame: 12 weeks from enrolment
measure: The proportion of participants who complete DAA therapy in prison
timeFrame: End of Treatment (8 weeks from treatment initiation)
measure: The proportion of people who have an end of treatment response
timeFrame: End of Treatment (8 weeks from treatment initiation)
measure: The proportion of people who have an HCV treatment response (sustained virological response)
timeFrame: Sustained virological response at 12 weeks post treatment completion
measure: The time taken from testing to each step in the care cascade
timeFrame: Varying, up to 9 months post-enrolment.
measure: The proportion of people lost to follow-up
timeFrame: Varying, up to end of study (estimated to be 12 months from study commencement)
measure: The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)
timeFrame: Varying, up to end of subject enrolment (estimated to be 12 months from study commencement)
measure: The proportion of people reinfected at SVR12
timeFrame: Varying, up to 9 months post-enrolment.
measure: The proportion of people reporting injecting risk behaviours (at ETR and SVR12)
timeFrame: Varying, up to 9 months post-enrolment.
measure: The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)
timeFrame: End of study (estimated to be 12 months from study commencement)
Other outcomes:
Locations:
city: Kempsey
country: Australia
facility: Mid North Coast Correctional Centre
state: New South Wales
Study officials:
affiliation: Kirby Institute, University NSW
name: Andrew Lloyd, Prof
role: PRINCIPAL_INVESTIGATOR
References: