Australian Hepatitis and Risk Survey in Prisons

NCT ID: NCT05839522

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-27

Study Completion Date

2023-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Hepatitis B HIV Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Point-of-care hepatitis C antibody test

Intervention Type DIAGNOSTIC_TEST

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

Point-of-care hepatitis C RNA test

Intervention Type DIAGNOSTIC_TEST

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

Point-of-care hepatitis B surface antibody test

Intervention Type DIAGNOSTIC_TEST

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

Point-of-care hepatitis B surface antigen test

Intervention Type DIAGNOSTIC_TEST

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

Point-of-care HIV antibody test

Intervention Type DIAGNOSTIC_TEST

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

Interview-style survey

Intervention Type BEHAVIORAL

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

Interventions

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Point-of-care hepatitis C antibody test

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

Intervention Type DIAGNOSTIC_TEST

Point-of-care hepatitis C RNA test

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

Intervention Type DIAGNOSTIC_TEST

Point-of-care hepatitis B surface antibody test

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

Intervention Type DIAGNOSTIC_TEST

Point-of-care hepatitis B surface antigen test

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

Intervention Type DIAGNOSTIC_TEST

Point-of-care HIV antibody test

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

Intervention Type DIAGNOSTIC_TEST

Interview-style survey

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

Intervention Type BEHAVIORAL

Other Intervention Names

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OraQuick HCV Rapid Antibody Test Xpert HCV VL Fingerstick QuickProfile HBsAb Fingerstick test Alere Determine 2 HBsAg Fingerstick Test OraQuick Rapid ADVANCE HIV 1/2 Antibody Test

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alexander Maconochie Centre

Hume, Australian Capital Territory, Australia

Site Status NOT_YET_RECRUITING

Bathurst Correctional Complex

Bathurst, New South Wales, Australia

Site Status COMPLETED

John Morony Correctional Complex

Berkshire Park, New South Wales, Australia

Site Status COMPLETED

Cessnock Correctional Centre

Cessnock, New South Wales, Australia

Site Status COMPLETED

Mid North Coast Correctional Centre

Kempsey, New South Wales, Australia

Site Status COMPLETED

South Coast Correctional Centre

Nowra, New South Wales, Australia

Site Status COMPLETED

Silverwater Women's Correctional Centre

Silverwater, New South Wales, Australia

Site Status COMPLETED

Wellington Correctional Centre

Wuuluman, New South Wales, Australia

Site Status COMPLETED

Alice Springs Correctional Centre

Alice Springs, Northern Territory, Australia

Site Status NOT_YET_RECRUITING

Darwin Correctional Centre

Howard Springs, Northern Territory, Australia

Site Status NOT_YET_RECRUITING

Borallon Training and Correctional Centre

Ironbark, Queensland, Australia

Site Status RECRUITING

Brisbane Women's Correctional Centre

Ironbark, Queensland, Australia

Site Status COMPLETED

Wolston Correctional Centre

Ironbark, Queensland, Australia

Site Status COMPLETED

Townsville Correctional Centre

Townsville, Queensland, Australia

Site Status COMPLETED

Mobilong Prison

Murray Bridge, South Australia, Australia

Site Status COMPLETED

Adelaide Women's Prison

Northfield, South Australia, Australia

Site Status COMPLETED

Yatala Labour Prison

Northfield, South Australia, Australia

Site Status COMPLETED

Mary Hutchinson Women's Prison

Risdon Vale, Tasmania, Australia

Site Status COMPLETED

Risdon Maximum Prison

Risdon Vale, Tasmania, Australia

Site Status COMPLETED

Ron Barwick Minimum Security Prison

Risdon Vale, Tasmania, Australia

Site Status COMPLETED

Bunbury Regional Prison

Bunbury, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Casuarina Prison

Casuarina, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Roebourne Regional Prison

Roebourne, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Bandyup Women's Prison

West Swan, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Countries

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Australia

Central Contacts

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Andrew Lloyd

Role: CONTACT

02 9385 2534

Yumi Sheehan

Role: CONTACT

02 9385 0375

Other Identifiers

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VISP1901

Identifier Type: -

Identifier Source: org_study_id

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