Combating Related Epidemics in HCV (NCT07560046) | Clinical Trial Compass
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 range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
. 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.