The QuickStart Study

QuickStart is exploring strategies to increase hepatitis C testing and treatment through the use of rapid point-of-care tests and a same-day test and treat model in primary care settings.

Objective

Hepatitis C treatment uptake is declining in Australia. We want to reverse that. Without an increase in people tested and being treated, Australia will not meet its hepatitis C elimination targets.

The current model of hepatitis C care requires people to attend multiple visits to health services, resulting in a substantial drop-off between each visit. Studies have suggested that rapid point-of-care (POC) hepatitis C tests reduce barriers to diagnosis and consequently improve the hepatitis C care cascade.

However, few studies on POC testing to date report on linkage to care, and none have shown their utility in enhancing the coverage of treatment and rates of hepatitis C cure.

Through three different models of care, QuickStart explores the impact of using rapid point-of-care hepatitis C (antibody and RNA) tests and a same-day test and treat strategy on testing uptake, treatment initiation and cure.

QuickStart aims to simplify hepatitis C testing pathways which may lead to earlier complete diagnosis, and for those infected, treatment.

Approach

QuickStart is a cluster cross-over randomised controlled trial with three intervention arms (see below) that reflect the different models of care being explored in the study. Participating primary care services receive one intervention for three months and the standard of care for three months. Half the services have an intervention followed by standard of care and the other half standard of care first. Cluster randomisation is performed at the service level.

Arm A

HCV rapid antibody testing alone followed by standard community-based treatment.

Arm B

HCV rapid antibody and rapid RNA test followed by standard community-based treatment.

Arm C

Same-day HCV rapid antibody testing followed by treatment initiation model.

Control Arm

Standard of care HCV management that requires multiple diagnostic and prescribing visits.

Eligible participants for the study are individuals who are attending a participating primary care service who have injected drugs at least once, had no previous treatment with DAAs for HCV and are aged 18 years or over. The target recruitment at each service is 60 - 80 eligible participants per service (30-40 each in intervention and control arms).

Analysis will compare the number of participants who start HCV treatment and those who achieve HCV cure within a primary care setting using standard of care testing and treatment with those who undertake Arm A, Arm B or Arm C.

A qualitative component seeks to understand the implementation, causal mechanisms and the contextual factors which shape the outcomes of the trial through an evaluation exploring experiences and perspectives of both health service clients and health providers.

Community impact

QuickStart aims to improve the quality of life for people living with hepatitis C by simplifying testing and treatment pathways. For the population most impacted by HCV, people who inject drugs (PWID), deploying rapid POC testing and immediate treatment at the same visit could dramatically improve engagement in care and increase the number of people cured.

Increasing cure rates will improve the well-being of these individuals and also reduce burden on health care systems.