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Trial registered on ANZCTR


Registration number
ACTRN12619001489189
Ethics application status
Approved
Date submitted
11/10/2019
Date registered
29/10/2019
Date last updated
29/10/2019
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prisons evaluation of a one-stop-shop InterVentiOn to scale-up hepatitis C testing and Treatment: the PIVOT study
Scientific title
Prisons evaluation of a one-stop-shop InterVentiOn to scale-up hepatitis C testing and Treatment: the PIVOT study
Secondary ID [1] 297126 0
UNSW VISP0105
Universal Trial Number (UTN)
Trial acronym
PIVOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 311146 0
Condition category
Condition code
Public Health 309774 309774 0 0
Health service research
Infection 313325 313325 0 0
Other infectious diseases
Oral and Gastrointestinal 313326 313326 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
An interventional cohort study will be used to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, linkage to hepatitis care, non-invasive liver fibrosis assessment, and same-visit direct-acting antiviral (DAA) prescription, on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.

During the initial control period, all people who are newly incarcerated (in the previous six weeks) will be offered participation and will receive the standard of care with the current health service model. The control period will allow observation of throughput in the current health service model, which includes an initial reception interview for medical, psychiatric and substance abuse concerns (conducted within 24 hours of incarceration), which may be followed by referral for HCV screening by the Clinical Nurse Specialists. The Clinical Nurse Specialists are located in each prison and conduct risk assessments for blood borne virus infection, followed by laboratory testing, and then subsequent provision of results, and for those with chronic HCV an offer of referral for further assessment for DAA treatment. This referral is made to the Hepatitis Clinical Nurse Consultants who undertake structured clinical assessments (utilising structured proformas including a review of possible medication interactions with DAAs), further laboratory investigations, followed by fibro-elastography, and then case review with a specialist physician for DAA prescription. This model is associated with an estimated mean of 3-4 months between initial testing and engagement with the Hepatitis Service, and subsequent commencement of DAA therapy.

After a control period of approximately 12 weeks (dependent on recruitment rate) to enrol n=240 individuals, all people who are newly incarcerated (in the previous six weeks) will be offered participation in the intervention period which will continue for approximately 24 weeks (dependent on recruitment rate) to enrol n=480 individuals.

The intervention period will be based on establishment of a 'one-stop-shop' hepatitis clinic. During the intervention period participants will undertake an initial screening which includes study consent and questionnaire, followed by point-of-care HCV RNA testing, point-of-care hepatitis B surface antigen (HBsAg) testing, followed by clinical assessment, non-invasive liver fibrosis assessment by fibro-elastography, and early DAA prescription followed by linkage to ongoing hepatitis care, all in the same 60-minute visit. A dedicated research nurse will perform all assessments and procedures in the 'one-stop-shop', followed by initiation of antiviral therapy for those eligible, and routine monitoring with point-of-care HCV RNA testing at end of treatment (ETR) and 12 weeks post treatment (SVR12).
Intervention code [1] 314102 0
Diagnosis / Prognosis
Intervention code [2] 315918 0
Treatment: Other
Intervention code [3] 315919 0
Behaviour
Comparator / control treatment
Current throughput of the standard of care through the existing health service model: Justice Health & Forensic Mental Health Network (JH&FMHN) Hepatitis Service.
Control group
Active

Outcomes
Primary outcome [1] 319635 0
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment, as assessed by electronic health record review.
Timepoint [1] 319635 0
12 weeks from enrolment
Secondary outcome [1] 369935 0
The proportion of people tested for HCV infection at 12 weeks from enrolment
Timepoint [1] 369935 0
12 weeks from enrolment
Secondary outcome [2] 369936 0
The proportion of participants who complete DAA therapy in prison, as assessed by electronic health record review.
Timepoint [2] 369936 0
End of Treatment (8 weeks from treatment initiation)
Secondary outcome [3] 369937 0
The proportion of people who have an end of treatment response, as assessed by electronic health record review.
Timepoint [3] 369937 0
End of Treatment (8 weeks from treatment initiation)
Secondary outcome [4] 369938 0
The proportion of people who have an HCV treatment response (sustained virological response), as assessed by electronic health record review.
Timepoint [4] 369938 0
Sustained virological response at 12 weeks post treatment completion
Secondary outcome [5] 369939 0
The time taken from testing to each step in the care cascade, as assessed by electronic health record review
Timepoint [5] 369939 0
Varying, up to 9 months post-enrolment.
Secondary outcome [6] 372213 0
To conduct a cost-effectiveness analysis between the ‘one-stop-shop’ approach and the standard of care, as assessed by calculating difference between resource use and costs from electronic health record review
Timepoint [6] 372213 0
End of study (estimated to be 12 months from study commencement)

Eligibility
Key inclusion criteria
Potential participants will be eligible to participate in the trial if the subject:
1) has provided written, informed consent to participate;
2) is male and greater than or equal to 18 years of age on enrolment;
3) has been incarcerated within the last six weeks.
For HCV RNA positive participants commencing treatment:
4) is HCV DAA treatment naïve;
5) and if HIV-1 infected must also meet the following criteria:
a. 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
b. 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
Potential participants will be excluded from participating in the trial if the subject:
1) is unable or unwilling to provide informed consent or abide by the requirements of the study;
2) is unable to gain an accurate reading on the fibroscan or the result is invalid;
For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
3) previous HCV DAA treatment experience;
4) untreated HIV co-infection;
5) chronic HBV co-infection;
6) 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;
7) known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (> 12.5 Kpa).

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



Intervention assignment
Other
Other design features
The first group (n=240) of participants enrolled in the study will be assigned to the control period to receive the standard of care. After this, the second group (n=480) of participants enrolled in the study will be assigned to the intervention period to receive the 'one-stop-shop' intervention.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the control period, a total of n=240 individuals will be recruited, with 80 anticipated to be confirmed to have chronic HCV (30%) and 40 subsequently initiated on DAA treatment via the Hepatitis Service (50% of those eligible). During the intervention period, n=480 individuals recruited and screened in the on-site clinics with an anticipated n=160 who are HCV RNA positive (30%) and n=120 being initiated on DAA treatment (75%). This study has 96% power to detect a difference in the proportion initiating DAA treatment during the control and intervention periods (p<0.05). The study also has 82% power to detect an increase in DAA initiation from 50% in the control period to 70% in the intervention period.

Participant characteristics at baseline will be summarised by control and intervention time periods, but not formally compared (i.e. no p-values). The primary endpoint is treatment initiation, and the proportion of eligible participants who initiate DAA treatment in the control and intervention time periods will be compared using chi-square tests. If there appear to be important imbalances in baseline characteristics, control and intervention comparisons will be adjusted using logistic regression. The statistical analyses will be performed only when all participants have completed SVR12 and all participant data has been entered into the study database. Those released to freedom will be considered separately in the analysis. A detailed statistical analysis plan will be developed towards completion of the study, and prior to analyses being performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2019
Actual
Date of last participant enrolment
Anticipated
28/07/2020
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14946 0
Mid North Coast Correctional Centre - Aldavilla
Recruitment postcode(s) [1] 28231 0
2440 - Aldavilla

Funding & Sponsors
Funding source category [1] 301687 0
Commercial sector/Industry
Name [1] 301687 0
AbbVie Pty Ltd.
Country [1] 301687 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
The Kirby Institute
Wallace Wurth Building
UNSW Sydney
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 303197 0
None
Name [1] 303197 0
Address [1] 303197 0
Country [1] 303197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302407 0
Justice Health & Forensic Mental Health Network (JH&FMHN) Human Research Ethics Committee
Ethics committee address [1] 302407 0
Ethics committee country [1] 302407 0
Australia
Date submitted for ethics approval [1] 302407 0
25/10/2018
Approval date [1] 302407 0
18/04/2019
Ethics approval number [1] 302407 0
Ethics committee name [2] 303747 0
Aboriginal Health and Medical Research Council of NSW Human Research Ethics Committee
Ethics committee address [2] 303747 0
Ethics committee country [2] 303747 0
Australia
Date submitted for ethics approval [2] 303747 0
26/11/2018
Approval date [2] 303747 0
10/07/2019
Ethics approval number [2] 303747 0
Ethics committee name [3] 303748 0
Corrective Services New South Wales Ethics Committee
Ethics committee address [3] 303748 0
Ethics committee country [3] 303748 0
Australia
Date submitted for ethics approval [3] 303748 0
02/05/2019
Approval date [3] 303748 0
07/08/2019
Ethics approval number [3] 303748 0

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

Contacts
Principal investigator
Name 90134 0
Prof Andrew Lloyd
Address 90134 0
Viral Immunology Systems Program (VISP), The Kirby Institute
Level 5, Wallace Wurth Building
UNSW Sydney
Kensington NSW 2052
Country 90134 0
Australia
Phone 90134 0
+61 2 9385 2534
Fax 90134 0
Email 90134 0
a.lloyd@unsw.edu.au
Contact person for public queries
Name 90135 0
Yumi Sheehan
Address 90135 0
Viral Immunology Systems Program (VISP), The Kirby Institute
Level 5, Wallace Wurth Building
UNSW Sydney
Kensington NSW 2052
Country 90135 0
Australia
Phone 90135 0
+61 2 9385 0375
Fax 90135 0
Email 90135 0
ysheehan@kirby.unsw.edu.au
Contact person for scientific queries
Name 90136 0
Andrew Lloyd
Address 90136 0
Viral Immunology Systems Program (VISP), The Kirby Institute
Level 5, Wallace Wurth Building
UNSW Sydney
Kensington NSW 2052
Country 90136 0
Australia
Phone 90136 0
+61 2 9385 2534
Fax 90136 0
Email 90136 0
a.lloyd@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial may be shared, after de-identification, upon request to the researchers.
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?
Data may be available to researchers on a case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
Data may be available to researchers upon request for conducting IPD meta-analyses (separate ethics approval required).
How or where can data be obtained?
Access to data is subject to approvals by Principal Investigator (a.lloyd@unsw.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5283Clinical study report    A link to the report will be provided upon publica... [More Details]



Results publications and other study-related documents

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