Hepatitis CPIVOTNCT04809246
Prisons Evaluation of a One-stop-shop InterVentiOn
A study testing 'One-stop-shop' hepatitis clinic in people with Hepatitis C, run by Kirby Institute at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- 'One-stop-shop' hepatitis clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Oct 2019to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- has provided written, informed consent to participate;
- is male and ≥18 years of age on enrolment;
- has been incarcerated within the last six weeks;
- is HCV DAA treatment naïve;
- is able and willing to provide informed consent and abide by the requirements of the study.
- For HCV RNA positive participants commencing treatment:
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- if HIV-1 infected must also meet the following criteria:
- 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
- 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/ )
Who cannot join
- For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
- untreated HIV co-infection;
- chronic HBV co-infection;
- 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;
- is unable to gain an accurate reading on the fibroscan or the result is invalid;
- known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (> 12.5 Kpa).
Trial locations and contacts
1 site in 1 country.
Australia1 site
Mid North Coast Correctional Centre
Kempsey, New South Wales, 2441
About this study
Official title: Prisons Evaluation of a One-stop-shop InterVentiOn to Scale-up Hepatitis C Testing and Treatment (PIVOT)
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.
- Conditions
- Hepatitis C
- Being tested
- 'One-stop-shop' hepatitis clinic
- Keywords
- Hepatitis C, Public Health, Health Service, Prisons
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'One-stop-shop' hepatitis clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | 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 | 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. Receives: Other: 'One-stop-shop' hepatitis clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
Measured: 12 weeks from enrolment
Secondary outcomes (10)
The proportion of people tested for HCV infection at 12 weeks from enrolment
Measured: 12 weeks from enrolment
The proportion of participants who complete DAA therapy in prison
Measured: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an end of treatment response
Measured: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an HCV treatment response (sustained virological response)
Measured: Sustained virological response at 12 weeks post treatment completion
The time taken from testing to each step in the care cascade
Measured: Varying, up to 9 months post-enrolment.
The proportion of people lost to follow-up
Measured: Varying, up to end of study (estimated to be 12 months from study commencement)
The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)
Measured: Varying, up to end of subject enrolment (estimated to be 12 months from study commencement)
The proportion of people reinfected at SVR12
Measured: Varying, up to 9 months post-enrolment.
The proportion of people reporting injecting risk behaviours (at ETR and SVR12)
Measured: Varying, up to 9 months post-enrolment.
The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)
Measured: End of study (estimated to be 12 months from study commencement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start31 Oct 2019
- Primary completion23 Apr 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Justice Health & Forensic Mental Health Network NSW Australia
- Responsible party
- Sponsor
- Investigators
- Andrew Lloyd, Prof, Principal investigator, Kirby Institute, University NSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809246
- Sponsor's protocol ID
- VISP0105
- Acronym
- PIVOT
- Status last verified
- Jan 2022
- First submitted
- 2 Feb 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
Sheehan Y, Cunningham EB, Cochrane A, Byrne M, Brown T, McGrath C, Lafferty L, Tedla N, Dore GJ, Lloyd AR, Grebely J. A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study. J Hepatol. 2023 Sep;79(3):635-644. doi: 10.1016/j.jhep.2023.04.019. Epub 2023 Apr 26.
PubMed 37116714Lafferty L, Sheehan Y, Cochrane A, Grebely J, Lloyd AR, Treloar C. Reducing barriers to the hepatitis C care cascade in prison via point-of-care RNA testing: a qualitative exploration of men in prison using an integrated framework. Addiction. 2023 Jun;118(6):1153-1160. doi: 10.1111/add.16137. Epub 2023 Feb 12.
PubMed 36683132
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prisons Evaluation of a One-stop-shop InterVentiOn to Scale-up Hepatitis C Testing and Treatment (PIVOT)
- ClinicalTrials.gov ID
- NCT04809246
- Acronym / sponsor ID
- PIVOT / VISP0105
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Public Health, Health Service, Prisons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Justice Health & Forensic Mental Health Network NSW Australia
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –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 | Other: 'One-stop-shop' hepatitis clinicFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- has provided written, informed consent to participate;
- is male and ≥18 years of age on enrolment;
- has been incarcerated within the last six weeks;
- is HCV DAA treatment naïve;
- is able and willing to provide informed consent and abide by the requirements of the study.
Key exclusion criteria (6 listed)
- For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
- untreated HIV co-infection;
- chronic HBV co-infection;
- 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;
- is unable to gain an accurate reading on the fibroscan or the result is invalid;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'One-stop-shop' hepatitis clinicEstablishment 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. | Other | 'One-stop-shop' intervention |
Primary outcome
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment
Time frame: 12 weeks from enrolment
10 secondary outcomes
The proportion of people tested for HCV infection at 12 weeks from enrolment
Time frame: 12 weeks from enrolment
The proportion of participants who complete DAA therapy in prison
Time frame: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an end of treatment response
Time frame: End of Treatment (8 weeks from treatment initiation)
The proportion of people who have an HCV treatment response (sustained virological response)
Time frame: Sustained virological response at 12 weeks post treatment completion
The time taken from testing to each step in the care cascade
Time frame: Varying, up to 9 months post-enrolment.
The proportion of people lost to follow-up
Time frame: Varying, up to end of study (estimated to be 12 months from study commencement)
The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)
Time frame: Varying, up to end of subject enrolment (estimated to be 12 months from study commencement)
The proportion of people reinfected at SVR12
Time frame: Varying, up to 9 months post-enrolment.
The proportion of people reporting injecting risk behaviours (at ETR and SVR12)
Time frame: Varying, up to 9 months post-enrolment.
The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)
Time frame: End of study (estimated to be 12 months from study commencement)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 37116714Sheehan Y, Cunningham EB, Cochrane A, Byrne M, Brown T, McGrath C, Lafferty L, Tedla N, Dore GJ, Lloyd AR, Grebely J. A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study. J Hepatol. 2023 Sep;79(3):635-644. doi: 10.1016/j.jhep.2023.04.019. Epub 2023 Apr 26.
- Derived from this study: PubMed 36683132Lafferty L, Sheehan Y, Cochrane A, Grebely J, Lloyd AR, Treloar C. Reducing barriers to the hepatitis C care cascade in prison via point-of-care RNA testing: a qualitative exploration of men in prison using an integrated framework. Addiction. 2023 Jun;118(6):1153-1160. doi: 10.1111/add.16137. Epub 2023 Feb 12.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Lloyd, Prof principal investigator
Kirby Institute, University NSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'One-stop-shop' hepatitis clinic in people with Hepatitis C, run by Kirby Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of people who have initiated DAA therapy within 12 weeks from enrolment (time frame: 12 weeks from enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809246, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.