Hepatitis CAusHepNCT05839522
Australian Hepatitis and Risk Survey in Prisons
An observational study of Hepatitis C and Hepatitis B, run by Kirby Institute at 24 sites in Australia.
Trial summary
The Australian Hepatitis and risk survey in prisons (AusHep) is a national prison-based blood-borne virus (BBV) surveillance study. This biobehavioural survey involves point-of-care testing for hepatitis C (HCV) antibodies and RNA (if antibody positive), hepatitis B surface antigens, hepatitis B surface antibodies… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hepatitis B, HIV Infections
- What is being tested?
- Point-of-care hepatitis C antibody test, Point-of-care hepatitis C RNA test and Point-of-care hepatitis B surface antibody test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,400 participants
- Where
- 24 sitesAustralia
- Study dates
- 27 Apr 2022to 1 May 2023
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the selected correctional centre(s) in each jurisdiction. All prisoners, including remandees and sentenced prisoners at the selected site(s) will be randomly selected to participate.
Who may be able to join
- Any remandee or sentenced prisoner who has provided informed consent is eligible to participate in the study.
Who cannot join
- Individuals who are unable or unwilling to provide consent or abide by the requirements of the study, as assessed by the trained nurses. Some individuals may be considered unable to provide consent or abide by the requirements of the study if they are:
- Too mentally unwell to provide consent
- Profoundly intellectually impaired
- Unable to speak English and comprehend the survey.
- Those excluded from participating in the study will be referred to the local prison clinic service for standard of care.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Australia24 sites, 8 recruiting
- Not yet recruiting
Alice Springs Correctional Centre
Alice Springs, Northern Territory, 0872
- Completed
Bathurst Correctional Complex
Bathurst, New South Wales, 2795
- Completed
John Morony Correctional Complex
Berkshire Park, New South Wales, 2756
- Not yet recruiting
Bunbury Regional Prison
Bunbury, Western Australia, 6230
- Not yet recruiting
Casuarina Prison
Casuarina, Western Australia, 6167
- Completed
Cessnock Correctional Centre
Cessnock, New South Wales, 2325
- Not yet recruiting
Darwin Correctional Centre
Howard Springs, Northern Territory, 0828
- Not yet recruiting
Alexander Maconochie Centre
Hume, Australian Capital Territory, 2620
- Recruiting
Borallon Training and Correctional Centre
Ironbark, Queensland, 4306
- Completed
Brisbane Women's Correctional Centre
Ironbark, Queensland, 4306
- Completed
Wolston Correctional Centre
Ironbark, Queensland, 4306
- Completed
Mid North Coast Correctional Centre
Kempsey, New South Wales, 2440
- Completed
Mobilong Prison
Murray Bridge, South Australia, 5253
- Completed
Adelaide Women's Prison
Northfield, South Australia, 5085
- Completed
Yatala Labour Prison
Northfield, South Australia, 5085
- Completed
South Coast Correctional Centre
Nowra, New South Wales, 2541
- Completed
Mary Hutchinson Women's Prison
Risdon Vale, Tasmania, 7016
- Completed
Risdon Maximum Prison
Risdon Vale, Tasmania, 7016
- Completed
Ron Barwick Minimum Security Prison
Risdon Vale, Tasmania, 7016
- Not yet recruiting
Roebourne Regional Prison
Roebourne, Western Australia, 6718
- Completed
Silverwater Women's Correctional Centre
Silverwater, New South Wales, 2128
- Completed
Townsville Correctional Centre
Townsville, Queensland, 4811
- Not yet recruiting
Bandyup Women's Prison
West Swan, Western Australia, 6055
- Completed
Wellington Correctional Centre
Wuuluman, New South Wales, 2820
About this study
The Australian Hepatitis and risk survey in prisons (AusHep) is a national prison-based blood-borne virus (BBV) surveillance study. This biobehavioural survey involves point-of-care testing for hepatitis C (HCV) antibodies and RNA (if antibody positive), hepatitis B surface antigens, hepatitis B surface antibodies, and HIV surface antibodies, and an interview-style survey on prior testing and treatment history and engagement in risk behaviours. The study will recruit approximately 2400 prisoner participants from 25 representative prisons across Australia, annually.
- Conditions
- Hepatitis C, Hepatitis B, HIV Infections
- Being tested
- Point-of-care hepatitis C antibody test, Point-of-care hepatitis C RNA test, Point-of-care hepatitis B surface antibody test, Point-of-care hepatitis B surface antigen test, Point-of-care HIV antibody test
- Keywords
- Blood-borne viruses, Prisons, Surveillance
- Medical subject headings
- Hepatitis C, Hepatitis B, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care hepatitis C antibody testDiagnostic test
Also called OraQuick HCV Rapid Antibody Test
Qualitative point-of-care test for hepatitis C antibodies (saliva sample)
Point-of-care hepatitis C RNA testDiagnostic test
Also called Xpert HCV VL Fingerstick
Hepatitis C Viral Load point-of-care test (fingerstick wholeblood sample)
Point-of-care hepatitis B surface antibody testDiagnostic test
Also called QuickProfile HBsAb Fingerstick test
Qualitative hepatitis B surface antibody point-of-care test (fingerstick wholeblood sample)
Point-of-care hepatitis B surface antigen testDiagnostic test
Also called Alere Determine 2 HBsAg Fingerstick Test
Qualitative hepatitis B surface antigen point-of-care test (fingerstick wholeblood sample)
Point-of-care HIV antibody testDiagnostic test
Also called OraQuick Rapid ADVANCE HIV 1/2 Antibody Test
Qualitative HIV antibody point-of-care test (saliva sample)
Interview-style surveyBehavioural
Interview-style survey regarding demographics, risk behaviours, BBV testing and treatment history, and point-of-care testing acceptability
| Study group | Role | What they receive |
|---|---|---|
| Persons in custody in Australia | Representative sample of 2400 people in prison from 25 representative prisons in Australia will participate in a biobehavioural survey involving point-of-care testing for HCV antibodies and RNA (if antibody positive), HBV surface antigens and antibodies, and HIV antibodies, and an interview-style survey. Receives: Diagnostic Test: Point-of-care hepatitis C antibody test; Diagnostic Test: Point-of-care hepatitis C RNA test; Diagnostic Test: Point-of-care hepatitis B surface antibody test; Diagnostic Test: Point-of-care hepatitis B surface antigen test; Diagnostic Test: Point-of-care HIV antibody test; Behavioral: Interview-style survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of HCV in Australian prisons
This is estiamted by perfroming the HCV antibody test and HCV RNA viral load test on a representative prison population.
Measured: 1 Year
The prevalance of HBV in Australian prisons
This is estimated by performing the HBV surface antigen test on a respresentative prison population
Measured: 1 year
The prevalance of HIV in Australian prisons
This is estimated by performing the HIV antibody test on a respresentative prison population.
Measured: 1 year
Secondary outcomes (4)
The proportion of individuals who are engaged in each step of HBV and HCV care cascades
This is estimated by conducting the bio-behavioural survey.
Measured: 1 Year
The prevalence of risk behaviours and harm reduction access
The risk behavrious and harm reduction measures include injecting and non-injecting drug use, high risk injecting practices, sexual risk behaviours, tattooing; and bleach or opioid substitution therapy (OST) uptake. This is estimated by conducting the bio-behavioural survey.
Measured: 1 Year
The factors associated with HCV and HBV infection investigated by the bio-behavioural survey.
Measured: 1 Year
The factors associated with engaging in each step of HCV and HBV care cascades and HBV vaccination investigated by the bio-behavioural survey.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start27 Apr 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839522
- Sponsor's protocol ID
- VISP1901
- Acronym
- AusHep
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Australian Hepatitis and Risk Survey in Prisons
- ClinicalTrials.gov ID
- NCT05839522
- Acronym / sponsor ID
- AusHep / VISP1901
- Conditions
- Hepatitis C, Hepatitis B, HIV Infections
- Keywords
- Blood-borne viruses, Prisons, Surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 May 2023 (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.
The Australian Hepatitis and risk survey in prisons (AusHep) is a national prison-based blood-borne virus (BBV) surveillance study. This biobehavioural survey involves point-of-care testing for hepatitis C (HCV) antibodies and RNA (if antibody positive), hepatitis B surface antigens, hepatitis B surface antibodies, and HIV surface antibodies, and an interview-style survey on prior testing and treatment history and engagement in risk behaviours. The study will recruit approximately 2400 prisoner participants from 25 representative prisons across Australia, annually.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons in custody in Australia | – | Diagnostic Test: Point-of-care hepatitis C antibody test, Diagnostic Test: Point-of-care hepatitis C RNA test, Diagnostic Test: Point-of-care hepatitis B surface antibody test, Diagnostic Test: Point-of-care hepatitis B surface antigen test, Diagnostic Test: Point-of-care HIV antibody test, Behavioral: Interview-style surveyRepresentative sample of 2400 people in prison from 25 representative prisons in Australia will participate in a biobehavioural survey involving point-of-care testing for HCV antibodies and RNA (if antibody positive), HBV surface antigens and antibodies, and HIV antibodies, and an interview-style survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the selected correctional centre(s) in each jurisdiction. All prisoners, including remandees and sentenced prisoners at the selected site(s) will be randomly selected to participate.
Key inclusion criteria (1 listed)
- Any remandee or sentenced prisoner who has provided informed consent is eligible to participate in the study.
Key exclusion criteria (5 listed)
- Individuals who are unable or unwilling to provide consent or abide by the requirements of the study, as assessed by the trained nurses. Some individuals may be considered unable to provide consent or abide by the requirements of the study if they are:
- Those excluded from participating in the study will be referred to the local prison clinic service for standard of care.
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 |
|---|---|---|
| Point-of-care hepatitis C antibody testAlso: OraQuick HCV Rapid Antibody TestQualitative point-of-care test for hepatitis C antibodies (saliva sample) | Diagnostic test | Persons in custody in Australia |
| Point-of-care hepatitis C RNA testAlso: Xpert HCV VL FingerstickHepatitis C Viral Load point-of-care test (fingerstick wholeblood sample) | Diagnostic test | Persons in custody in Australia |
| Point-of-care hepatitis B surface antibody testAlso: QuickProfile HBsAb Fingerstick testQualitative hepatitis B surface antibody point-of-care test (fingerstick wholeblood sample) | Diagnostic test | Persons in custody in Australia |
| Point-of-care hepatitis B surface antigen testAlso: Alere Determine 2 HBsAg Fingerstick TestQualitative hepatitis B surface antigen point-of-care test (fingerstick wholeblood sample) | Diagnostic test | Persons in custody in Australia |
| Point-of-care HIV antibody testAlso: OraQuick Rapid ADVANCE HIV 1/2 Antibody TestQualitative HIV antibody point-of-care test (saliva sample) | Diagnostic test | Persons in custody in Australia |
| Interview-style surveyInterview-style survey regarding demographics, risk behaviours, BBV testing and treatment history, and point-of-care testing acceptability | Behavioural | Persons in custody in Australia |
Primary outcome
The prevalence of HCV in Australian prisons
Time frame: 1 Year
This is estiamted by perfroming the HCV antibody test and HCV RNA viral load test on a representative prison population.
The prevalance of HBV in Australian prisons
Time frame: 1 year
This is estimated by performing the HBV surface antigen test on a respresentative prison population
The prevalance of HIV in Australian prisons
Time frame: 1 year
This is estimated by performing the HIV antibody test on a respresentative prison population.
4 secondary outcomes
The proportion of individuals who are engaged in each step of HBV and HCV care cascades
Time frame: 1 Year
The prevalence of risk behaviours and harm reduction access
Time frame: 1 Year
The factors associated with HCV and HBV infection investigated by the bio-behavioural survey.
Time frame: 1 Year
The factors associated with engaging in each step of HCV and HBV care cascades and HBV vaccination investigated by the bio-behavioural survey.
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hepatitis B, run by Kirby Institute at 24 sites 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Lloyd (02 9385 2534, a.lloyd@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of HCV in Australian prisons (time frame: 1 Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.