Australian Hepatitis and Risk Survey in Prisons

HIV Infections Clinical Trial

— AusHep  

Official title:

Australian Hepatitis and Risk Survey in Prisons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839522
• Other study ID #: VISP1901
• Status: Recruiting
• Start date: April 27, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2023
• Source: Kirby Institute
• Contact: Andrew Lloyd
• Phone: 02 9385 2534
• Email: a.lloyd[@]unsw.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV Infections

Intervention

Diagnostic Test:
• Point-of-care hepatitis C antibody test
Qualitative point-of-care test for hepatitis C antibodies (saliva sample)
• Point-of-care hepatitis C RNA test
Hepatitis C Viral Load point-of-care test (fingerstick wholeblood sample)
• Point-of-care hepatitis B surface antibody test
Qualitative hepatitis B surface antibody point-of-care test (fingerstick wholeblood sample)
• Point-of-care hepatitis B surface antigen test
Qualitative hepatitis B surface antigen point-of-care test (fingerstick wholeblood sample)
• Point-of-care HIV antibody test
Qualitative HIV antibody point-of-care test (saliva sample)

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

Locations

Country	Name	City	State
Australia	Alice Springs Correctional Centre	Alice Springs	Northern Territory
Australia	Bathurst Correctional Complex	Bathurst	New South Wales
Australia	John Morony Correctional Complex	Berkshire Park	New South Wales
Australia	Bunbury Regional Prison	Bunbury	Western Australia
Australia	Casuarina Prison	Casuarina	Western Australia
Australia	Cessnock Correctional Centre	Cessnock	New South Wales
Australia	Darwin Correctional Centre	Howard Springs	Northern Territory
Australia	Alexander Maconochie Centre	Hume	Australian Capital Territory
Australia	Borallon Training and Correctional Centre	Ironbark	Queensland
Australia	Brisbane Women's Correctional Centre	Ironbark	Queensland
Australia	Wolston Correctional Centre	Ironbark	Queensland
Australia	Mid North Coast Correctional Centre	Kempsey	New South Wales
Australia	Mobilong Prison	Murray Bridge	South Australia
Australia	Adelaide Women's Prison	Northfield	South Australia
Australia	Yatala Labour Prison	Northfield	South Australia
Australia	South Coast Correctional Centre	Nowra	New South Wales
Australia	Mary Hutchinson Women's Prison	Risdon Vale	Tasmania
Australia	Risdon Maximum Prison	Risdon Vale	Tasmania
Australia	Ron Barwick Minimum Security Prison	Risdon Vale	Tasmania
Australia	Roebourne Regional Prison	Roebourne	Western Australia
Australia	Silverwater Women's Correctional Centre	Silverwater	New South Wales
Australia	Townsville Correctional Centre	Townsville	Queensland
Australia	Bandyup Women's Prison	West Swan	Western Australia
Australia	Wellington Correctional Centre	Wuuluman	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The prevalance of HBV in Australian prisons	This is estimated by performing the HBV surface antigen test on a respresentative prison population	1 year
Primary	The prevalance of HIV in Australian prisons	This is estimated by performing the HIV antibody test on a respresentative prison population.	1 year
Secondary	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
Secondary	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
Secondary	The factors associated with HCV and HBV infection investigated by the bio-behavioural survey.		1 Year
Secondary	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