Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05839522




Registration number
NCT05839522
Ethics application status
Date submitted
6/03/2023
Date registered
3/05/2023
Date last updated
3/05/2023

Titles & IDs
Public title
Australian Hepatitis and Risk Survey in Prisons
Scientific title
Australian Hepatitis and Risk Survey in Prisons
Secondary ID [1] 0 0
VISP1901
Universal Trial Number (UTN)
Trial acronym
AusHep
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Hepatitis B 0 0
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Point-of-care hepatitis C antibody test
Diagnosis / Prognosis - Point-of-care hepatitis C RNA test
Diagnosis / Prognosis - Point-of-care hepatitis B surface antibody test
Diagnosis / Prognosis - Point-of-care hepatitis B surface antigen test
Diagnosis / Prognosis - Point-of-care HIV antibody test
BEHAVIORAL - Interview-style survey

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.


Diagnosis / Prognosis: Point-of-care hepatitis C antibody test
Qualitative point-of-care test for hepatitis C antibodies (saliva sample)

Diagnosis / Prognosis: Point-of-care hepatitis C RNA test
Hepatitis C Viral Load point-of-care test (fingerstick wholeblood sample)

Diagnosis / Prognosis: Point-of-care hepatitis B surface antibody test
Qualitative hepatitis B surface antibody point-of-care test (fingerstick wholeblood sample)

Diagnosis / Prognosis: Point-of-care hepatitis B surface antigen test
Qualitative hepatitis B surface antigen point-of-care test (fingerstick wholeblood sample)

Diagnosis / Prognosis: 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
Intervention code [1] 0 0
Diagnosis / Prognosis
Intervention code [2] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The prevalence of HCV in Australian prisons
Timepoint [1] 0 0
1 Year
Primary outcome [2] 0 0
The prevalance of HBV in Australian prisons
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
The prevalance of HIV in Australian prisons
Timepoint [3] 0 0
1 year
Secondary outcome [1] 0 0
The proportion of individuals who are engaged in each step of HBV and HCV care cascades
Timepoint [1] 0 0
1 Year
Secondary outcome [2] 0 0
The prevalence of risk behaviours and harm reduction access
Timepoint [2] 0 0
1 Year
Secondary outcome [3] 0 0
The factors associated with HCV and HBV infection investigated by the bio-behavioural survey.
Timepoint [3] 0 0
1 Year
Secondary outcome [4] 0 0
The factors associated with engaging in each step of HCV and HBV care cascades and HBV vaccination investigated by the bio-behavioural survey.
Timepoint [4] 0 0
1 Year

Eligibility
Key inclusion criteria
* Any remandee or sentenced prisoner who has provided informed consent is eligible to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
2400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA
Recruitment hospital [1] 0 0
Alexander Maconochie Centre - Hume
Recruitment hospital [2] 0 0
Bathurst Correctional Complex - Bathurst
Recruitment hospital [3] 0 0
John Morony Correctional Complex - Berkshire Park
Recruitment hospital [4] 0 0
Cessnock Correctional Centre - Cessnock
Recruitment hospital [5] 0 0
Mid North Coast Correctional Centre - Kempsey
Recruitment hospital [6] 0 0
South Coast Correctional Centre - Nowra
Recruitment hospital [7] 0 0
Silverwater Women's Correctional Centre - Silverwater
Recruitment hospital [8] 0 0
Wellington Correctional Centre - Wuuluman
Recruitment hospital [9] 0 0
Alice Springs Correctional Centre - Alice Springs
Recruitment hospital [10] 0 0
Darwin Correctional Centre - Howard Springs
Recruitment hospital [11] 0 0
Borallon Training and Correctional Centre - Ironbark
Recruitment hospital [12] 0 0
Brisbane Women's Correctional Centre - Ironbark
Recruitment hospital [13] 0 0
Wolston Correctional Centre - Ironbark
Recruitment hospital [14] 0 0
Townsville Correctional Centre - Townsville
Recruitment hospital [15] 0 0
Mobilong Prison - Murray Bridge
Recruitment hospital [16] 0 0
Adelaide Women's Prison - Northfield
Recruitment hospital [17] 0 0
Yatala Labour Prison - Northfield
Recruitment hospital [18] 0 0
Mary Hutchinson Women's Prison - Risdon Vale
Recruitment hospital [19] 0 0
Risdon Maximum Prison - Risdon Vale
Recruitment hospital [20] 0 0
Ron Barwick Minimum Security Prison - Risdon Vale
Recruitment hospital [21] 0 0
Bunbury Regional Prison - Bunbury
Recruitment hospital [22] 0 0
Casuarina Prison - Casuarina
Recruitment hospital [23] 0 0
Roebourne Regional Prison - Roebourne
Recruitment hospital [24] 0 0
Bandyup Women's Prison - West Swan
Recruitment postcode(s) [1] 0 0
2620 - Hume
Recruitment postcode(s) [2] 0 0
2795 - Bathurst
Recruitment postcode(s) [3] 0 0
2756 - Berkshire Park
Recruitment postcode(s) [4] 0 0
2325 - Cessnock
Recruitment postcode(s) [5] 0 0
2440 - Kempsey
Recruitment postcode(s) [6] 0 0
2541 - Nowra
Recruitment postcode(s) [7] 0 0
2128 - Silverwater
Recruitment postcode(s) [8] 0 0
2820 - Wuuluman
Recruitment postcode(s) [9] 0 0
0872 - Alice Springs
Recruitment postcode(s) [10] 0 0
0828 - Howard Springs
Recruitment postcode(s) [11] 0 0
4306 - Ironbark
Recruitment postcode(s) [12] 0 0
4811 - Townsville
Recruitment postcode(s) [13] 0 0
5253 - Murray Bridge
Recruitment postcode(s) [14] 0 0
5085 - Northfield
Recruitment postcode(s) [15] 0 0
7016 - Risdon Vale
Recruitment postcode(s) [16] 0 0
6230 - Bunbury
Recruitment postcode(s) [17] 0 0
6167 - Casuarina
Recruitment postcode(s) [18] 0 0
6718 - Roebourne
Recruitment postcode(s) [19] 0 0
6055 - West Swan

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05839522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Lloyd
Address 0 0
Country 0 0
Phone 0 0
02 9385 2534
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05839522