Hepatitis CSCALE-CNCT03776760
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
An observational study of Hepatitis C and Hepatitis, run by Kirby Institute at 4 sites in Australia.
Trial summary
A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hepatitis, Liver Diseases
- What is being tested?
- Fingerstick GeneXpert HCV RNA quantitative assay, sofosbuvir/velpatesvir and glecaprevir/pibrentasvir
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 4 sitesAustralia
- Study dates
- 28 May 2019to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People attending Aboriginal health services will be invited to receive HCV RNA testing using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection will be offered treatment with one of two pan-genotypic direct acting antiviral therapies available in Australia (SOF/VEL or G/P)
Who may be able to join
- 18 years of age or older;
- voluntarily signed the informed consent form.
Who cannot join
- Pregnant women.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites, 4 recruiting
- Recruiting
Jullums Lismore Aboriginal Medical Service
Lismore, New South Wales, 2480
Peter Silberberg, +612 6621 4366, peter@jullums.com
- Recruiting
Pangula Mannamurna Aboriginal Corporation
Mount Gambier, South Australia, 5290
Kellie Morello, +61 8 8724 7270, kellie.m@pangula.org.au
- Recruiting
Port Lincoln Aboriginal Health Service
Port Lincoln, South Australia, 5606
Sharon Bilney, +618 8683 0162, Sharon.Bilney@plahs.org.au
- Recruiting
Walhallow Aboriginal Corporation
Quirindi, New South Wales, 2343
Suruchi Amarasena, MBBS, +612 6746 2001, suruchiaaa@gmail.com
About this study
A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.
Read the detailed description
SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.
- Conditions
- Hepatitis C, Hepatitis, Liver Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Digestive System Diseases
- Being tested
- Fingerstick GeneXpert HCV RNA quantitative assay, sofosbuvir/velpatesvir, glecaprevir/pibrentasvir
- Medical subject headings
- Hepatitis C, Hepatitis, Liver Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerstick GeneXpert HCV RNA quantitative assayDevice
All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly
sofosbuvir/velpatesvirDrug
Also called Epclusa
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
glecaprevir/pibrentasvirDrug
Also called Maviret
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
| Study group | Role | What they receive |
|---|---|---|
| Fingerstick Point of Care GeneXpert HCV Test | Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay. Receives: Device: Fingerstick GeneXpert HCV RNA quantitative assay; Drug: sofosbuvir/velpatesvir; Drug: glecaprevir/pibrentasvir | |
| Treat - SOF/VEL | Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir Receives: Drug: sofosbuvir/velpatesvir | |
| Treat - G/P | Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir Receives: Drug: glecaprevir/pibrentasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hepatitis C prevalence
Change in the proportion of people with current HCV infection (HCV RNA positive)
Measured: Week 0 to week 144
Secondary outcomes (4)
Change in Hepatitis C incidence
Change in HCV incidence will be calculated using person-time of observation.
Measured: Week 0 to week 144
DAA uptake
Proportion with HCV infection initiating DAA therapy
Measured: To week 144
Treatment response rate (SVR12 rate)
Overall SVR12 rate in those who commence treatment
Measured: From week 0 to Week 144
HCV reinfection incidence post treatment
Participants will be assessed six monthly post end of treatment for HCV recurrence.
Measured: 6 monthly from end of treatment until week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start28 May 2019
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- South Australian Health and Medical Research Institute, Flinders University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776760
- Sponsor's protocol ID
- VHCRP1802
- Acronym
- SCALE-C
- Status last verified
- Apr 2022
- First submitted
- 21 Nov 2018
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hosseini-Hooshyar S, Valerio H, Flynn E, Sexton C, Barzi F, Amarasena S, De Koster L, Sellen D, Winterfield N, Grebely J, Matthews GV, Boyd MA, Applegate TL, Petoumenos K, Lafferty L, Dore GJ, Treloar C, Martinello M, Ward J. A point-of-care testing intervention to improve hepatitis C diagnosis and treatment uptake among people attending Aboriginal community controlled health services: the SCALE-C study. BMC Infect Dis. 2025 Nov 17;25(1):1604. doi: 10.1186/s12879-025-12004-z.
PubMed 41250046
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
- ClinicalTrials.gov ID
- NCT03776760
- Acronym / sponsor ID
- SCALE-C / VHCRP1802
- Conditions
- Hepatitis C, Hepatitis, Liver Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Digestive System Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- South Australian Health and Medical Research Institute, Flinders University
- Study start
- 28 May 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.
Detailed description
SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fingerstick Point of Care GeneXpert HCV Test | – | Device: Fingerstick GeneXpert HCV RNA quantitative assay, Drug: sofosbuvir/velpatesvir, Drug: glecaprevir/pibrentasvirParticipants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay. |
| Treat - SOF/VEL | – | Drug: sofosbuvir/velpatesvirParticipants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir |
| Treat - G/P | – | Drug: glecaprevir/pibrentasvirParticipants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People attending Aboriginal health services will be invited to receive HCV RNA testing using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection will be offered treatment with one of two pan-genotypic direct acting antiviral therapies available in Australia (SOF/VEL or G/P)
Key inclusion criteria (2 listed)
- 18 years of age or older;
- voluntarily signed the informed consent form.
Key exclusion criteria (1 listed)
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingerstick GeneXpert HCV RNA quantitative assayAll participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly | Device | Fingerstick Point of Care GeneXpert HCV Test |
| sofosbuvir/velpatesvirAlso: EpclusaParticipants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia | Drug | Fingerstick Point of Care GeneXpert HCV Test, Treat - SOF/VEL |
| glecaprevir/pibrentasvirAlso: MaviretParticipants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia | Drug | Fingerstick Point of Care GeneXpert HCV Test, Treat - G/P |
Primary outcome
Change in Hepatitis C prevalence
Time frame: Week 0 to week 144
Change in the proportion of people with current HCV infection (HCV RNA positive)
4 secondary outcomes
Change in Hepatitis C incidence
Time frame: Week 0 to week 144
DAA uptake
Time frame: To week 144
Treatment response rate (SVR12 rate)
Time frame: From week 0 to Week 144
HCV reinfection incidence post treatment
Time frame: 6 monthly from end of treatment until week 144
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 41250046Hosseini-Hooshyar S, Valerio H, Flynn E, Sexton C, Barzi F, Amarasena S, De Koster L, Sellen D, Winterfield N, Grebely J, Matthews GV, Boyd MA, Applegate TL, Petoumenos K, Lafferty L, Dore GJ, Treloar C, Martinello M, Ward J. A point-of-care testing intervention to improve hepatitis C diagnosis and treatment uptake among people attending Aboriginal community controlled health services: the SCALE-C study. BMC Infect Dis. 2025 Nov 17;25(1):1604. doi: 10.1186/s12879-025-12004-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hepatitis, run by Kirby Institute at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerard Estivill (+612 9385 0900, gestivill@kirby.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hepatitis C prevalence (time frame: Week 0 to week 144). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.