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Combating Related Epidemics in HCV

Study acronym: CREST
StatusNot Yet Recruiting
PhasePhase 4
Started2026-08-01
View on ClinicalTrials.gov ↗

Amendment history

2026-04-30
Study Status, Outcome Measures v1
Primary endpoint(s) modified1 entry, revised
WasProportion of participants who complete the HCV care cascade within 24 weeks of study entry in intervention versus SOC arm.
NowProportion of participants who complete the Hepatitis C Virus (HCV) care cascade within 24 weeks of study entry in intervention versus Standard of Care (SOC) arm.
Secondary endpoints20 entries, revised
Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only) Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry Proportion of participants achieving sustained virologic response (SVR4+) within 60 weeks of entry Cumulative incidence of HCV reinfection following sustained viro [...] [...]
2026-04-23
Original filing
Duke University
455 trials monitored
See 53 trials at risk
This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.
Trial Details
NCT Number NCT07560046
Lead Sponsor Duke University
Collaborators: Yale University, West Virginia University, University of San Diego, Cepheid, Gilead Sciences, Abbott, National Institute of Allergy and Infectious Diseases (NIAID), Flinders University International Centre for Point-of-care Testing, Kirby Institute
Conditions HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV), HEPATITIS C (HCV)
Enrollment 1,280 participants
Start Date 2026-08-01
Primary Completion 2030-11-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-05