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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04809246




Registration number
NCT04809246
Ethics application status
Date submitted
2/02/2021
Date registered
22/03/2021

Titles & IDs
Public title
Prisons Evaluation of a One-stop-shop InterVentiOn
Scientific title
Prisons Evaluation of a One-stop-shop InterVentiOn to Scale-up Hepatitis C Testing and Treatment (PIVOT)
Secondary ID [1] 0 0
VISP0105
Universal Trial Number (UTN)
Trial acronym
PIVOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 'One-stop-shop' hepatitis clinic

No intervention: 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.

Experimental: '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.


Other 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
Timepoint [1] 0 0
12 weeks from enrolment
Secondary outcome [1] 0 0
The proportion of people tested for HCV infection at 12 weeks from enrolment
Timepoint [1] 0 0
12 weeks from enrolment
Secondary outcome [2] 0 0
The proportion of participants who complete DAA therapy in prison
Timepoint [2] 0 0
End of Treatment (8 weeks from treatment initiation)
Secondary outcome [3] 0 0
The proportion of people who have an end of treatment response
Timepoint [3] 0 0
End of Treatment (8 weeks from treatment initiation)
Secondary outcome [4] 0 0
The proportion of people who have an HCV treatment response (sustained virological response)
Timepoint [4] 0 0
Sustained virological response at 12 weeks post treatment completion
Secondary outcome [5] 0 0
The time taken from testing to each step in the care cascade
Timepoint [5] 0 0
Varying, up to 9 months post-enrolment.
Secondary outcome [6] 0 0
The proportion of people lost to follow-up
Timepoint [6] 0 0
Varying, up to end of study (estimated to be 12 months from study commencement)
Secondary outcome [7] 0 0
The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)
Timepoint [7] 0 0
Varying, up to end of subject enrolment (estimated to be 12 months from study commencement)
Secondary outcome [8] 0 0
The proportion of people reinfected at SVR12
Timepoint [8] 0 0
Varying, up to 9 months post-enrolment.
Secondary outcome [9] 0 0
The proportion of people reporting injecting risk behaviours (at ETR and SVR12)
Timepoint [9] 0 0
Varying, up to 9 months post-enrolment.
Secondary outcome [10] 0 0
The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)
Timepoint [10] 0 0
End of study (estimated to be 12 months from study commencement)

Eligibility
Key inclusion 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/ )
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
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).

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/09/2021
Sample size
Target
Accrual to date
Final
541
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Mid North Coast Correctional Centre - Kempsey
Recruitment postcode(s) [1] 0 0
2441 - Kempsey

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Justice Health & Forensic Mental Health Network NSW Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Lloyd, Prof
Address 0 0
Kirby Institute, University NSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data may be available immediately following publication for 7 years, no end date determined, upon request to the researchers.

Data may be available to researchers on a case-by-case basis at the discretion of Principal Investigator. Data may be available to researchers upon request for conducting IPD meta-analyses (separate ethics approval required). Access to data is subject to approvals by Principal Investigator (a.lloyd@unsw.edu.au)

Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
Data may be available immediately following publication for 7 years, no end date determined, upon request to the researchers.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04809246