Australian Hepatitis and Risk Survey in Prisons

Study Overview
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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.

Official Title
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Australian Hepatitis and Risk Survey in Prisons

Conditions
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Hepatitis C, Hepatitis B, HIV Infections

Intervention / Treatment
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* 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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons in custody in Australia<br>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<br>* Qualitative point-of-care test for hepatitis C antibodies (saliva sample)<br>* Other names: OraQuick HCV Rapid Antibody Test;Diagnostic Test: Point-of-care hepatitis C RNA test<br>* Hepatitis C Viral Load point-of-care test (fingerstick wholeblood sample)<br>* Other names: Xpert HCV VL Fingerstick;Diagnostic Test: Point-of-care hepatitis B surface antibody test<br>* Qualitative hepatitis B surface antibody point-of-care test (fingerstick wholeblood sample)<br>* Other names: QuickProfile HBsAb Fingerstick test;Diagnostic Test: Point-of-care hepatitis B surface antigen test<br>* Qualitative hepatitis B surface antigen point-of-care test (fingerstick wholeblood sample)<br>* Other names: Alere Determine 2 HBsAg Fingerstick Test;Diagnostic Test: Point-of-care HIV antibody test<br>* Qualitative HIV antibody point-of-care test (saliva sample)<br>* Other names: OraQuick Rapid ADVANCE HIV 1/2 Antibody Test;Behavioral: Interview-style survey<br>* Interview-style survey regarding demographics, risk behaviours, BBV testing and treatment history, and point-of-care testing acceptability<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prisons, Blood-borne viruses, Surveillance