The World Health Organisation has set global elimination targets to reduce new hepatitis C virus (HCV) infections by 90% and decrease HCV-related deaths by 65% by the year 2030. Most countries are unlikely to meet these goals without new approaches to models of care to reduce transmissions and increase diagnoses. In the United States the current approach to HCV diagnosis and treatment is a multi-step process taking weeks to months that results in significant loss to care before treatment initiation.
Newly approved point-of-care tests for HCV RNA can compress the process from diagnosis to treatment initiation into a single visit. These test & treat approaches can be completed in non-specialist settings (e.g., community health centres, substance use disorder treatment programs, correctional facilities, and mobile units) to increase access for marginalised patients.
CREST is a two-arm cluster randomized controlled trial to compare a single-visit point-of-care (POC) test & treat bundle to the current standard-of-care to enhance HCV diagnosis and treatment uptake among people attending community-based clinical sites across the US.
Sites are randomised 1:1 to implement either the POC test & treat bundle or the standard-of-care approach to all eligible participants. The aim is to determine the proportion of participants with detectable HCV RNA at enrolment who have undetectable HCV RNA at 24 weeks after enrolment. Additionally, qualitative interviews will inform the development of widescale implementation and dissemination strategies, and mathematical modelling will assess the cost-effectiveness, population impact, and budgetary implications of a test & treat bundle.
Participants will be recruited from community-based clinical sites that provide services to key populations such as people who inject drugs or people with or at risk of HIV across the US. All participants will complete dried blood spot testing at enrolment and will receive either a POC test & treat bundle (consists of fingerstick tests for detection of HCV RNA, HIV antibody, and hepatitis B surface antigen) or referral to testing through recommended local clinical practice, depending on cluster randomization.
All participants with detectable HCV RNA will be offered HCV treatment, education and linkage to care for HIV treatment or prevention, and will complete follow-up visits at 3 months, 6 months and 1 year.
CREST leverages a US-Australian collaboration to conduct an innovative and urgently needed single-visit POC test & treat intervention trial for HCV within key populations. The study will have broad implications for implementation and public health policy in the US and more broadly. Applying mixed methods approaches and mathematical modelling to data collected from the trial will inform implementation of POC test & treat models of care and extend the accuracy and utility of mathematical modelling related to US and WHO HCV elimination targets.
- Duke University
- Flinders University International Centre for Point-of-care Testing
- PRISMA Health
- University of San Diego
- Yale University
- West Virginia University
CREST is funded by National Institute of Allergy and Infectious Diseases
(NIAID) Clinical Trial Implementation Cooperative Agreement. Additional research support has been provided by Gilead Sciences, Cepheid, and BioLytical Laboratories.
