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Clinical Trials/NCT05839522
NCT05839522RecruitingNot Applicable

Australian Hepatitis and Risk Survey in Prisons

Kirby Institute24 sites in 1 country2,400 target enrollmentStarted: April 27, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
2,400
Locations
24
Primary Endpoint
The prevalence of HCV in Australian prisons

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

The prevalence of HCV in Australian prisons

Time Frame: 1 Year

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

The prevalance of HBV in Australian prisons

Time Frame: 1 year

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

The prevalance of HIV in Australian prisons

Time Frame: 1 year

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

Secondary Outcomes

  • The factors associated with HCV and HBV infection investigated by the bio-behavioural survey.(1 Year)
  • The proportion of individuals who are engaged in each step of HBV and HCV care cascades(1 Year)
  • The prevalence of risk behaviours and harm reduction access(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)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (24)

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