Australian Hepatitis and Risk Survey in Prisons

NCT05839522 | Unknown

• 1 other identifier: VISP1901
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 24

Brief 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, 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

Keywords

Blood-borne viruses; Prisons; Surveillance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• The proportion of individuals who are engaged in each step of HBV and HCV care cascades

  1 Year

• The prevalence of risk behaviours and harm reduction access

  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

Study Arms (1)

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; 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

Interventions

Point-of-care hepatitis C antibody test DIAGNOSTIC_TEST

Qualitative point-of-care test for hepatitis C antibodies (saliva sample)

Also known as: OraQuick HCV Rapid Antibody Test

Persons in custody in Australia

Point-of-care hepatitis C RNA test DIAGNOSTIC_TEST

Hepatitis C Viral Load point-of-care test (fingerstick wholeblood sample)

Also known as: Xpert HCV VL Fingerstick

Persons in custody in Australia

Point-of-care hepatitis B surface antibody test DIAGNOSTIC_TEST

Qualitative hepatitis B surface antibody point-of-care test (fingerstick wholeblood sample)

Also known as: QuickProfile HBsAb Fingerstick test

Persons in custody in Australia

Point-of-care hepatitis B surface antigen test DIAGNOSTIC_TEST

Qualitative hepatitis B surface antigen point-of-care test (fingerstick wholeblood sample)

Also known as: Alere Determine 2 HBsAg Fingerstick Test

Persons in custody in Australia

Point-of-care HIV antibody test DIAGNOSTIC_TEST

Qualitative HIV antibody point-of-care test (saliva sample)

Also known as: OraQuick Rapid ADVANCE HIV 1/2 Antibody Test

Persons in custody in Australia

Interview-style survey BEHAVIORAL

Interview-style survey regarding demographics, risk behaviours, BBV testing and treatment history, and point-of-care testing acceptability

Persons in custody in Australia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (24)

Alexander Maconochie Centre

Hume, Australian Capital Territory, 2620, Australia

NOT YET RECRUITING

Bathurst Correctional Complex

Bathurst, New South Wales, 2795, Australia

COMPLETED

John Morony Correctional Complex

Berkshire Park, New South Wales, 2756, Australia

COMPLETED

Cessnock Correctional Centre

Cessnock, New South Wales, 2325, Australia

COMPLETED

Mid North Coast Correctional Centre

Kempsey, New South Wales, 2440, Australia

COMPLETED

South Coast Correctional Centre

Nowra, New South Wales, 2541, Australia

COMPLETED

Silverwater Women's Correctional Centre

Silverwater, New South Wales, 2128, Australia

COMPLETED

Wellington Correctional Centre

Wuuluman, New South Wales, 2820, Australia

COMPLETED

Alice Springs Correctional Centre

Alice Springs, Northern Territory, 0872, Australia

NOT YET RECRUITING

Darwin Correctional Centre

Howard Springs, Northern Territory, 0828, Australia

NOT YET RECRUITING

Borallon Training and Correctional Centre

Ironbark, Queensland, 4306, Australia

RECRUITING

Brisbane Women's Correctional Centre

Ironbark, Queensland, 4306, Australia

COMPLETED

Wolston Correctional Centre

Ironbark, Queensland, 4306, Australia

COMPLETED

Townsville Correctional Centre

Townsville, Queensland, 4811, Australia

COMPLETED

Mobilong Prison

Murray Bridge, South Australia, 5253, Australia

COMPLETED

Adelaide Women's Prison

Northfield, South Australia, 5085, Australia

COMPLETED

Yatala Labour Prison

Northfield, South Australia, 5085, Australia

COMPLETED

Mary Hutchinson Women's Prison

Risdon Vale, Tasmania, 7016, Australia

COMPLETED

Risdon Maximum Prison

Risdon Vale, Tasmania, 7016, Australia

COMPLETED

Ron Barwick Minimum Security Prison

Risdon Vale, Tasmania, 7016, Australia

COMPLETED

Bunbury Regional Prison

Bunbury, Western Australia, 6230, Australia

NOT YET RECRUITING

Casuarina Prison

Casuarina, Western Australia, 6167, Australia

NOT YET RECRUITING

Roebourne Regional Prison

Roebourne, Western Australia, 6718, Australia

NOT YET RECRUITING

Bandyup Women's Prison

West Swan, Western Australia, 6055, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Hepatitis C; Hepatitis B; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Andrew Lloyd

CONTACT

02 9385 2534; a.lloyd@unsw.edu.au

Yumi Sheehan

CONTACT

02 9385 0375; ysheehan@kirby.unsw.edu.au

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 3, 2023
• Study Start: April 27, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (24)