AusHep: Australian Hepatitis and Risk Survey in Prisons

• Sponsor: Kirby Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05839522
• Collaborator: (none)
• Enrollment: 2,400
• Locations: 24
• Anticipated Duration (Months): 12.1
• Patients Per Site: 100
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C; Hepatitis B; HIV Infections	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 Design

• Study Type: Observational
• Anticipated Enrollment: 2400 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Australian Hepatitis and Risk Survey in Prisons
• Actual Study Start Date: Apr 27, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. The prevalence of HCV in Australian prisons [1 Year]

   This is estiamted by perfroming the HCV antibody test and HCV RNA viral load test on a representative prison population.

2. The prevalance of HBV in Australian prisons [1 year]

   This is estimated by performing the HBV surface antigen test on a respresentative prison population

3. The prevalance of HIV in Australian prisons [1 year]

   This is estimated by performing the HIV antibody test on a respresentative prison population.

Secondary Outcome Measures

1. The proportion of individuals who are engaged in each step of HBV and HCV care cascades [1 Year]

   This is estimated by conducting the bio-behavioural survey.

2. The prevalence of risk behaviours and harm reduction access [1 Year]

   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.

3. The factors associated with HCV and HBV infection investigated by the bio-behavioural survey. [1 Year]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexander Maconochie Centre	Hume	Australian Capital Territory	Australia	2620
2	Bathurst Correctional Complex	Bathurst	New South Wales	Australia	2795
3	John Morony Correctional Complex	Berkshire Park	New South Wales	Australia	2756
4	Cessnock Correctional Centre	Cessnock	New South Wales	Australia	2325
5	Mid North Coast Correctional Centre	Kempsey	New South Wales	Australia	2440
6	South Coast Correctional Centre	Nowra	New South Wales	Australia	2541
7	Silverwater Women's Correctional Centre	Silverwater	New South Wales	Australia	2128
8	Wellington Correctional Centre	Wuuluman	New South Wales	Australia	2820
9	Alice Springs Correctional Centre	Alice Springs	Northern Territory	Australia	0872
10	Darwin Correctional Centre	Howard Springs	Northern Territory	Australia	0828
11	Borallon Training and Correctional Centre	Ironbark	Queensland	Australia	4306
12	Brisbane Women's Correctional Centre	Ironbark	Queensland	Australia	4306
13	Wolston Correctional Centre	Ironbark	Queensland	Australia	4306
14	Townsville Correctional Centre	Townsville	Queensland	Australia	4811
15	Mobilong Prison	Murray Bridge	South Australia	Australia	5253
16	Adelaide Women's Prison	Northfield	South Australia	Australia	5085
17	Yatala Labour Prison	Northfield	South Australia	Australia	5085
18	Mary Hutchinson Women's Prison	Risdon Vale	Tasmania	Australia	7016
19	Risdon Maximum Prison	Risdon Vale	Tasmania	Australia	7016
20	Ron Barwick Minimum Security Prison	Risdon Vale	Tasmania	Australia	7016
21	Bunbury Regional Prison	Bunbury	Western Australia	Australia	6230
22	Casuarina Prison	Casuarina	Western Australia	Australia	6167
23	Roebourne Regional Prison	Roebourne	Western Australia	Australia	6718
24	Bandyup Women's Prison	West Swan	Western Australia	Australia	6055

Sponsors and Collaborators

• Kirby Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kirby Institute
• ClinicalTrials.gov Identifier: NCT05839522
• Other Study ID Numbers: VISP1901
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kirby Institute: Blood-borne viruses; Prisons; Surveillance
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Hepatitis; Antibodies; Immunoglobulins; HIV Antibodies; Hepatitis C Antibodies

Study Results

No Results Posted as of May 3, 2023