Not Yet RecruitingPhase 4

Combating Related Epidemics in HCV

1,280 participantsStarted 2026-08-01

Plain-language summary

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.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. Can provide written informed consent or assent
✓. Minimum of 16 years of age
✓. Willing to undergo HIV, HCV, HBV testing
✓. Willing to undergo treatment for HCV and complete study activities

Exclusion criteria

✕. History of HCV treatment for current infection
✕. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, or clinical evidence per the site PI
✕. Contraindication for treatment with sofosbuvir/velpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
✕. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
✕. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.
✕. Completion of sofosbuvir/velpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 \& CTP score available within 90-days of retreatment initiation.
✕. Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA \<LLOQ/D (TD or TND) during and/or at end of treatment followed by HCV RNA \>LLOQ/D or target detected based on qualitative POC test at any time point from end of treatment to 12 weeks after end of treatment OR Re-infection, defined as meeting the primary outcome criteria for SVR4+ followed by HCV RNA \>LLOQ/D or target detected based on qualitative POC test at any time point beyond meeting SVR4+ OR Post-treatment virologic failure, defined as HCV RNA \>LLOQ/D at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection
✕. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, clinical evidence per the site PI, or by CTP score ≥7.

What they're measuring

Proportion 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.

Timeframe: 24 weeks from study enrollment

Trial details

NCT IDNCT07560046

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-11-30

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