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Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)

NCT05016609 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2023-11-13

No results posted yet for this study

Summary

The QuickStart study aims to assess the impact of three models of HCV care on HCV treatment uptake and cure among people who inject drugs. Rapid point-of-care (POC) HCV testing and test-and-treat strategies will be utilised in primary health care settings across Australia.

Conditions

  • Hepatitis C

Interventions

DEVICE

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.

DEVICE

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.

DRUG

Sofosbuvir/Velpatasvir (Gilead)

Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.

Sponsors & Collaborators

  • Macfarlane Burnet Institute for Medical Research and Public Health Ltd

    lead OTHER

Principal Investigators

  • Joseph Doyle, MBBS, PhD · Burnet Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2024-04-30
Completion
2024-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05016609 on ClinicalTrials.gov