Australian Hepatitis and Risk Survey in Prisons (AusHep)

April 20, 2023 updated by: Kirby Institute
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Hume, Australian Capital Territory, Australia, 2620
        • Not yet recruiting
        • Alexander Maconochie Centre
    • New South Wales
      • Bathurst, New South Wales, Australia, 2795
        • Completed
        • Bathurst Correctional Complex
      • Berkshire Park, New South Wales, Australia, 2756
        • Completed
        • John Morony Correctional Complex
      • Cessnock, New South Wales, Australia, 2325
        • Completed
        • Cessnock Correctional Centre
      • Kempsey, New South Wales, Australia, 2440
        • Completed
        • Mid North Coast Correctional Centre
      • Nowra, New South Wales, Australia, 2541
        • Completed
        • South Coast Correctional Centre
      • Silverwater, New South Wales, Australia, 2128
        • Completed
        • Silverwater Women's Correctional Centre
      • Wuuluman, New South Wales, Australia, 2820
        • Completed
        • Wellington Correctional Centre
    • Northern Territory
      • Alice Springs, Northern Territory, Australia, 0872
        • Not yet recruiting
        • Alice Springs Correctional Centre
      • Howard Springs, Northern Territory, Australia, 0828
        • Not yet recruiting
        • Darwin Correctional Centre
    • Queensland
      • Ironbark, Queensland, Australia, 4306
        • Recruiting
        • Borallon Training and Correctional Centre
      • Ironbark, Queensland, Australia, 4306
        • Completed
        • Brisbane Women's Correctional Centre
      • Ironbark, Queensland, Australia, 4306
        • Completed
        • Wolston Correctional Centre
      • Townsville, Queensland, Australia, 4811
        • Completed
        • Townsville Correctional Centre
    • South Australia
      • Murray Bridge, South Australia, Australia, 5253
        • Completed
        • Mobilong Prison
      • Northfield, South Australia, Australia, 5085
        • Completed
        • Adelaide Women's Prison
      • Northfield, South Australia, Australia, 5085
        • Completed
        • Yatala Labour Prison
    • Tasmania
      • Risdon Vale, Tasmania, Australia, 7016
        • Completed
        • Mary Hutchinson Women's Prison
      • Risdon Vale, Tasmania, Australia, 7016
        • Completed
        • Risdon Maximum Prison
      • Risdon Vale, Tasmania, Australia, 7016
        • Completed
        • Ron Barwick Minimum Security Prison
    • Western Australia
      • Bunbury, Western Australia, Australia, 6230
        • Not yet recruiting
        • Bunbury Regional Prison
      • Casuarina, Western Australia, Australia, 6167
        • Not yet recruiting
        • Casuarina Prison
      • Roebourne, Western Australia, Australia, 6718
        • Not yet recruiting
        • Roebourne Regional Prison
      • West Swan, Western Australia, Australia, 6055
        • Not yet recruiting
        • Bandyup Women's Prison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Any remandee or sentenced prisoner who has provided informed consent is eligible to participate in the study.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Point-of-care hepatitis C antibody test
Qualitative point-of-care test for hepatitis C antibodies (saliva sample)
Other Names:
  • OraQuick HCV Rapid Antibody Test
Diagnostic test: Point-of-care hepatitis C RNA test
Hepatitis C Viral Load point-of-care test (fingerstick wholeblood sample)
Other Names:
  • Xpert HCV VL Fingerstick
Diagnostic test: Point-of-care hepatitis B surface antibody test
Qualitative hepatitis B surface antibody point-of-care test (fingerstick wholeblood sample)
Other Names:
  • QuickProfile HBsAb Fingerstick test
Diagnostic test: Point-of-care hepatitis B surface antigen test
Qualitative hepatitis B surface antigen point-of-care test (fingerstick wholeblood sample)
Other Names:
  • Alere Determine 2 HBsAg Fingerstick Test
Diagnostic test: Point-of-care HIV antibody test
Qualitative HIV antibody point-of-care test (saliva sample)
Other Names:
  • OraQuick Rapid ADVANCE HIV 1/2 Antibody Test
Behavioral: Interview-style survey
Interview-style survey regarding demographics, risk behaviours, BBV testing and treatment history, and point-of-care testing acceptability

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 Year
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
1 year
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of individuals who are engaged in each step of HBV and HCV care cascades
Time Frame: 1 Year
This is estimated by conducting the bio-behavioural survey.
1 Year
The prevalence of risk behaviours and harm reduction access
Time Frame: 1 Year
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.
1 Year
The factors associated with HCV and HBV infection investigated by the bio-behavioural survey.
Time Frame: 1 Year
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
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirby Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VISP1901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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