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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000524392
Ethics application status
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Approved
Date submitted
Help: Date submitted
13/01/2026
Date registered
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28/04/2026
Date last updated
Help: Date last updated
28/04/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/04/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Hepatitis C testing and treatment in people with serious mental illness: a cohort study of hospital inpatients and community outpatients (Reach Out)
Scientific title
Hepatitis C testing and treatment in people with serious mental illness: a cohort study of hospital inpatients and community outpatients (Reach Out)
Additional trial identifiers [1] 316248 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Hepatitis C 340279 0
Serious Mental Illness 340280 0
Condition category
Condition code
Mental Health 336477 336477 0 0
Addiction
Public Health 336478 336478 0 0
Health promotion/education
Infection 336479 336479 0 0
Other infectious diseases
Mental Health 336480 336480 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Offering people with serious mental illness (SMI) hepatitis C virus (HCV) testing may help achieve World Health Organization elimination targets by 2030 and enable this population to realise the benefits of hepatitis C cure.
In the Reach Out program, mental health nurses will offer point of care (POC) HCV antibody testing on a finger prick of blood, to community outpatients with SMI. The frequency of the HCV point of care antibody test is one time only. The test returns results within one minute and these results are provided to the participant immediately. Participants who test positive will be offered referral to the viral hepatitis service. Outcomes of referral will be analysed by review of the patient medical record.

In the the Reach In inpatient quality improvement activity, psychiatry resident and registrars will offer standard of care (SOC) HCV antibody testing on a routine blood test to hospital inpatients with serious mental illness. Participants who test positive will be offered treatment and linked to the viral hepatitis service within the hospital.

Patients with SMI and hepatitis C will be linked to SOC hepatitis C treatment via the Viral Hepatitis Service (VHS). The Viral Hepatitis Service at Barwon Health provides specialised care for individuals living with hepatitis B and C, offering comprehensive services including assessment, treatment, education, and support to patients across the Barwon South West region. The team consists of infectious diseases physicians, gastroenterologists and clinical nurses consultants, including an outreach nurse, working together to ensure holistic care. In addition to clinical care, the team are actively involved in viral hepatitis research, with a particular focus on improving models of care in regional and rural areas.
Intervention code [1] 332900 0
Early detection / Screening
Description of the comparator or control
We will compare the effect of the 24 week Reach Out Program (September 2025 - March 2026) in community outpatients 24-week period (March 2025 - August 2025) prior to Program implementation.
We will compare the effect of the 24 week Reach In Quality Improvement Activity (November 2025 - April 2026) to the retrospective group (September 2025 - December 2025) period prior (to Activity implementation. A shorter time period was chosen for comparison because of the large number of inpatients.
Historical hepatitis C testing data will be collected from the hospital medical record.
Control group
Historical

Outcomes
Primary outcome [1] 344067 0
To determine the proportion of people with SMI tested for hepatitis C antibody during the 24 week intervention/activity period, compared to the proportion of people with SMI tested for hepatitis C antibody during the pre-implementation periods (24 weeks for Reach Out Program, 12 weeks for Reach In inpatient quality improvement activity).
Timepoint [1] 344067 0
Measured at the end of the 24 week implementation period (compared to the 24 week period prior to implementation of the Reach Out program and the 12 week period prior to the Reach In inpatient quality improvement activity).
Primary outcome [2] 344068 0
To determine the proportion of people with SMI with a complete hepatitis C diagnosis during the 24 week intervention/activity period, compared to the proportion of people with SMI with a complete hepatitis C diagnosis during the pre-implementation period (24 weeks for Reach Out Program, 12 weeks for Reach In inpatient quality improvement activity).
Timepoint [2] 344068 0
Measured at the end of the 24 week implementation period (compared to the 24 week period prior to implementation for Reach Out Program and 12 week period prior to the Reach In inpatient quality improvement activity).
Primary outcome [3] 344069 0
To determine the prevalence of hepatitis C in people with SMI.
Timepoint [3] 344069 0
Measured after the 24 week period during implementation (compared to the 24 week period prior to implementation for Reach Out Program and 12 week period prior to the Reach In inpatient quality improvement activity).
Secondary outcome [1] 456623 0
To determine risk factors for HCV for people with SMI, for example, collecting behavioural data on injecting drug use, homelessness, incarceration, or unsterile tattoo or piercings.
Timepoint [1] 456623 0
The behavioural questionnaire will be measured at a single time point during the 24 week study period with each new recruit, with consent from the participant.
Secondary outcome [2] 456624 0
To determine the proportion of patients with SMI and hepatitis C who commenced treatment in the 24 weeks during the Reach Out program and Reach In inpatient quality improvement activity, compared to proportion of patients with SMI and hepatitis C who commenced treatment in the 24 weeks pre-Reach Out program and 12 weeks pre-Reach In inpatient quality improvement activity
Timepoint [2] 456624 0
measured after the 24 week implementation period

Eligibility
Key inclusion criteria
Reach Out Program Group - Inclusion criteria:
- Receiving case management from Barwon Mental Health
- Able to provide verbal consent for hepatitis C INSTI testing and/or questionnaire, audit of HCV care pathway.
- Age 18 years and over
- Eligible for Medicare

Reach Out retrospective (24 weeks pre-intervention* outpatient data set approx. 250 patients) group - Inclusion criteria for data applied for under waiver of consent:
- Receiving case management from Barwon Mental Health
- Age 18 years and over

Reach In Inpatient Quality Improvement group - Inclusion criteria
- Barwon Health inpatient under the Mental Health bed card:
- Able to provide verbal consent for questionnaire in English, HCV audit.
- Age 18 years and over

Reach In Inpatient retrospective group - Inclusion criteria for data applied for under waiver of consent:
- Barwon Health inpatient under the Mental Health bed card
- Age 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
N/A

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
We will compare the effect of the 24 week Reach Out Program in community outpatients 24-week period prior to Program implementation.
We will compare the effect of the 24 week Reach In Quality Improvement Activity to the 12 week period prior to Activity implementation. A shorter time period was chosen for comparison because of the large number of inpatients.
Historical hepatitis C testing data will be collected from the hospital medical record, etc.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to report baseline patient characteristics. For the Reach Out and Reach In groups, we will compare and inform the effect of the Program intervention to the 12-week (Reach In inpatient group) or 24-week (Reach Out Program) period prior to Program implementation.
A chi squared analysis will be performed to compare differences in the proportion tested, complete diagnoses and DAA treatments commenced. Logistic regression analyses will be used to identify predictors of hepatitis C infection and treatment uptake. The multivariate model for predictors of treatment uptake will explore factors that are significant at the 0.10 level in univariate analysis in a backwards stepwise model. Statistically significant differences will be assessed at the 0.05 level.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2025
Date of last participant enrolment
Anticipated
Actual
27/03/2026
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
50
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29177 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 45493 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 320852 0
Hospital
Name [1] 320852 0
Barwon Health, Business of Health Grant
Country [1] 320852 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Country
Australia
Secondary sponsor category [1] 323593 0
None
Name [1] 323593 0
Address [1] 323593 0
Country [1] 323593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319386 0
Barwon Health HREC
Ethics committee address [1] 319386 0
Ethics committee country [1] 319386 0
Australia
Date submitted for ethics approval [1] 319386 0
20/05/2025
Approval date [1] 319386 0
25/06/2025
Ethics approval number [1] 319386 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 147166 0
A/Prof Amanda Wade
Address 147166 0
Barwon Health, PO Box 281, Geelong VIC 3220
Country 147166 0
Australia
Phone 147166 0
+61 03 4215 0000
Fax 147166 0
Email 147166 0
[email protected]
Contact person for public queries
Name 147167 0
Tess Boocock
Address 147167 0
Barwon Health, PO Box 281, Geelong 3220
Country 147167 0
Australia
Phone 147167 0
+61 406564126
Fax 147167 0
Email 147167 0
[email protected]
Contact person for scientific queries
Name 147168 0
Amanda Wade
Address 147168 0
Barwon Health, PO Box 281, Geelong VIC 3220
Country 147168 0
Australia
Phone 147168 0
+61 03 4215 0000
Fax 147168 0
Email 147168 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.