Australian Hepatitis and Risk Survey in Prisons (AusHep)

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: Recruiting
• Conditions: HIV Infections; Hepatitis B; Hepatitis C
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Anticipated): 2400

Contacts and Locations

• Study Contact: Name: Andrew Lloyd; Phone Number: 02 9385 2534; Email: a.lloyd@unsw.edu.au
• Study Contact Backup: Name: Yumi Sheehan; Phone Number: 02 9385 0375; Email: ysheehan@kirby.unsw.edu.au

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	1 Year
The prevalance of HBV in Australian prisons	This is estimated by performing the HBV surface antigen test on a respresentative prison population	1 year
The prevalance of HIV in Australian prisons	This is estimated by performing the HIV antibody test on a respresentative prison population.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 Year
The factors associated with HCV and HBV infection investigated by the bio-behavioural survey.		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.		1 Year

Collaborators and Investigators

• Sponsor: Kirby Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Surveillance; Prisons; Blood-borne viruses
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis C; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; HIV Antibodies; Hepatitis C Antibodies
• Other Study ID 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