Trial Review

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 registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001040358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
12/01/2026
Date registered
Help: Date registered
24/08/2026
Date last updated
Help: Date last updated
24/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
FIDAA - Understanding the Experience of People Receiving Escalating Financial Incentives for the Testing and Uptake of Direct Acting Antivirals for Hepatitis C - A Feasibility Study.
Scientific title
Understanding the Experience of People Receiving Escalating Financial Incentives for the Testing and Uptake of Direct Acting Antivirals for Hepatitis C - A Feasibility Study.
Additional trial identifiers [1] 316294 0
None
Universal Trial Number (UTN)
Trial acronym
FIDAA
Related trial records

Health condition
Health condition(s) studied:
Hepatitis C 340339 0
Condition category
Condition code
Public Health 336539 336539 0 0
Health promotion/education
Infection 336931 336931 0 0
Other infectious diseases
Oral and Gastrointestinal 336932 336932 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants must complete the study hepatitis C point-of-care RNA test (HCV-POCT) and provide informed consent to participate. HCV-POCT is a rapid, on-site hepatitis C testing process in which a finger-prick blood sample is analysed using a portable device to detect HCV RNA, with results typically available within approximately 60 minutes. This enables participants to receive their results during the same visit and facilitates immediate linkage to care where required.
Participants who complete the study HCV-POCT and provide consent will receive a small reimbursement for completing a brief feedback survey and an incentive for collecting their HCV-POCT test results. The feedback survey is available in either paper or online format and takes approximately 5-10 minutes to complete. Participants who choose to remain on site to receive their test results (approximately 1 hour after testing) or telephone the service before close of business on the day of testing to obtain their results will receive an incentive for doing so.
Participants who complete HCV-POCT and test HCV RNA-positive are eligible for additional incentives for:
• attending a pre-treatment assessment;
• collecting direct-acting antiviral (DAA) medication; and
• completing follow-up testing to confirm cure (sustained virological response [SVR]).
For participants who test HCV RNA-negative, the intervention is completed on the day of testing.
For participants who test HCV RNA-positive, the intervention extends from the day of HCV-POCT through completion of follow-up testing to confirm cure. The minimum expected duration is approximately 8–12 weeks, depending on the prescribed DAA regimen and timely participant progression through each stage of care, including pre-treatment assessment, medication collection, treatment completion, and SVR assessment.
Intervention adherence and fidelity will be monitored through the maintenance of study records, including HCV-POCT testing logs, participant attendance records, and incentive distribution logs, to ensure that all intervention components are delivered consistently and in accordance with the study protocol.
Intervention code [1] 332941 0
Behaviour
Description of the comparator or control
Nil control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344050 0
Stage 1. Proportion of participants who, following consent to FIDAA, remain at the clinic or contact the service by close of business on the same day to receive their HCV point-of-care test (POCT) result.
Timepoint [1] 344050 0
Immediately following the HCV POCT visit, when the participant receives their POCT result, at latest by close of business.
Primary outcome [2] 344051 0
Stage 2. Proportion of HCV RNA-positive participants who complete the hepatitis C care pathway, defined as completion of pre-treatment assessment, collection of direct-acting antiviral (DAA) medication, and completion of sustained virological response (SVR) testing.
Timepoint [2] 344051 0
Assessed throughout Stage 2, with the primary timepoint at completion of SVR testing, undertaken 4–12 weeks after completion of DAA treatment in accordance with routine clinical practice.
Secondary outcome [1] 456572 0
Reasons for remaining at the clinic or not remaining to receive HCV POCT results.
Timepoint [1] 456572 0
Immediately following the HCV POCT visit, on the same day as HCV POCT testing and before or at collection of HCV POCT results.
Secondary outcome [2] 464328 0
Time from HCV POCT sample collection to receipt of HCV POCT results.
Timepoint [2] 464328 0
From HCV POCT sample collection until receipt of HCV POCT results on the same day or a later date.
Secondary outcome [3] 464329 0
Participant acceptability of contingency management (CM) incentives for treatment-related visits.
Timepoint [3] 464329 0
Immediately following the HCV POCT visit, on the same day as HCV POCT testing.
Secondary outcome [4] 464330 0
Participant acceptability of contingency management for collecting results and treatment of hepatitis C.
Timepoint [4] 464330 0
Assessed at Stage 1 prior to collection of results.
Secondary outcome [5] 466430 0
Barriers to achieving hepatitis C treatment milestones.
Timepoint [5] 466430 0
Assessed at Stage 1 prior to collection of results.
Secondary outcome [6] 466431 0
Enablers to achieving hepatitis C treatment milestones.
Timepoint [6] 466431 0
Assessed at Stage 1 prior to collection of results

Eligibility
Key inclusion criteria
Stage 1
> = 18 years of age.
Current Hunter New England Local Health District Drug and Alcohol Clinical Services client

Stage 2
Participants who receive a positive HCV-POCT RNA test at stage one
Participants who received HCV POCT RNA positive result within the 3 months prior to the commencement of FIDAA.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Stage 1 -
Unwilling to provide informed consent or abide by the requirements of the study.
People who have a negative HCV POCT antibody test result
People who have previously consented to participate in the FIDAA study within the past 3 months, unless the PI determines that re-enrolment is appropriate.

Stage 2 -
Unwilling to provide informed consent or abide by the requirements of the study.
Already engaged in HCV treatment
Enrolled in another HCV study with financial incentives

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/05/2026
Date of last participant enrolment
Anticipated
4/05/2027
Actual
Date of last data collection
Anticipated
27/07/2027
Actual
Sample size
Target
450
Accrual to date
111
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29049 0
Drug and Alcohol Clinical Services, Hunter New England Local Health District - Newcastle
Recruitment postcode(s) [1] 45331 0
2300 - Newcastle

Funding & Sponsors
Funding source category [1] 320891 0
Government body
Name [1] 320891 0
NHMRC 2024 Collaborations in Health Services Research Grant
Country [1] 320891 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Country
Australia
Secondary sponsor category [1] 323578 0
None
Name [1] 323578 0
Address [1] 323578 0
Country [1] 323578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319433 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 319433 0
Ethics committee country [1] 319433 0
Australia
Date submitted for ethics approval [1] 319433 0
28/11/2025
Approval date [1] 319433 0
15/12/2025
Ethics approval number [1] 319433 0
2025/ETH02595

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

Contacts
Principal investigator
Name 147310 0
Prof Adrian Dunlop
Address 147310 0
Drug and Alcohol Services, 670 Hunter St, Newcastle, NSW, 2302
Country 147310 0
Australia
Phone 147310 0
+61 02 4016 4664
Fax 147310 0
Email 147310 0
[email protected]
Contact person for public queries
Name 147311 0
Gillian Harris
Address 147311 0
Drug and Alcohol Services, 670 Hunter St, Newcastle, NSW, 2302
Country 147311 0
Australia
Phone 147311 0
+61 02 4016 4658
Fax 147311 0
Email 147311 0
[email protected]
Contact person for scientific queries
Name 147312 0
Adrian Dunlop
Address 147312 0
Drug and Alcohol Services, 670 Hunter St, Newcastle, NSW, 2302
Country 147312 0
Australia
Phone 147312 0
+61 02 4016 4658
Fax 147312 0
Email 147312 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    2025_ETH02595_ Application HREA - Approved - RE-ISSUED.pdf


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.