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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05016609




Registration number
NCT05016609
Ethics application status
Date submitted
16/08/2021
Date registered
23/08/2021

Titles & IDs
Public title
Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
Scientific title
Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)
Secondary ID [1] 0 0
HREC/64731/Alfred-2020-217547
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 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
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OraQuick HCV Antibody test (OraSure Technologies, Inc)
Treatment: Devices - Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
Treatment: Drugs - Sofosbuvir/Velpatasvir (Gilead)

Experimental: POC HCV antibody group (Arm A) - This group will receive POC HCV antibody testing via fingerprick using the OraQuick HCV antibody test (OraSure) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire.

Experimental: POC HCV RNA group (Arm B) - This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will receive POC HCV viral load testing via fingerstick using the Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire.

Experimental: Test and treat group (ArmC) - This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will be provided a starter pack of HCV treatment (epclusa). POC tests results will be confirmed through standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. HCV RNA positive participants will continue treatment. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire.

No intervention: Control - This group will receive the standard of care for HCV testing and treatment. Participants in this group will fill out a short behavioural questionnaire and a clinical questionnaire.


Treatment: Devices: OraQuick HCV Antibody test (OraSure Technologies, Inc)
The OraQuick HCV test is a point of care antibody test for detecting HCV antibodies in fingerstick blood. The test takes 20 minutes to provide a result. Appropriate pre- and post-test counselling will be provided to participants.

Treatment: Devices: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
Xpert® HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Only participants who return a reactive OraQuick HCV Antibody test will be offered the Xpert® HCV VL Fingerstick test. Appropriate pre- and post-test counselling will be provided to participants.

Treatment: Drugs: Sofosbuvir/Velpatasvir (Gilead)
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HCV treatment
Timepoint [1] 0 0
Within 12 weeks of enrolment
Primary outcome [2] 0 0
HCV cure
Timepoint [2] 0 0
HCV cure will be measured between 4 and 20 weeks post treatment completion.

Eligibility
Key inclusion criteria
* current or former PWID (i.e., injected drugs at least once)
* aged 18 years or over
* attending a participating PHC for any reason
* no previous treatment with DAAs for HCV
* failed interferon based treatment for HCV in the past (i.e., did not achieve cure)
* Medicare eligible
* able to speak and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* women known to be currently pregnant or who are breastfeeding
* individuals self-reporting to be currently engaged in treatment for HCV
* unable to provide informed consent
* tested for HCV in the past 3 months

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Mediclinic Australia - Clayton South
Recruitment hospital [2] 0 0
Innerspace - Collingwood
Recruitment hospital [3] 0 0
Corio Community Health Centre - Corio
Recruitment hospital [4] 0 0
Cohealth Fitzroy - Fitzroy
Recruitment hospital [5] 0 0
Homeless Healthcare - Highgate
Recruitment hospital [6] 0 0
Cockburn Wellbeing - Success
Recruitment postcode(s) [1] 0 0
3168 - Clayton South
Recruitment postcode(s) [2] 0 0
3066 - Collingwood
Recruitment postcode(s) [3] 0 0
3214 - Corio
Recruitment postcode(s) [4] 0 0
3065. - Fitzroy
Recruitment postcode(s) [5] 0 0
6003 - Highgate
Recruitment postcode(s) [6] 0 0
6164 - Success

Funding & Sponsors
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Joseph Doyle, MBBS, PhD
Address 0 0
Burnet Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Caitlin Douglass, BHSc(Hons)
Address 0 0
Country 0 0
Phone 0 0
+61404707275
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Requests for data sharing can be made to the principal investigator; further approval by the Human Research Ethics Committee may be necessary given the sensitive behaviour and risk information collected in the context of a trial of people who use drugs and hepatitis C testing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05016609