Combating Related Epidemics in HCV Through Simplified Testing and Treatment. A Cluster Randomized Trial of Point-of-care Hepatitis C Testing and Treatment Among Key Populations
| Registry | NCT07560046, acronym CREST |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 1280 (Estimated) |
| Sponsor | Duke University (Other); 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) |
| Interventions | Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab, Abbott Determine HbsAg 2, Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] (Device, drug) |
| Dates | start 2027-01-20 (estimated), primary completion 2030-11-30 (estimated), completion 2030-12-30 (estimated), first posted 2026-04-30, last updated 2026-10-15 |
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All trials for HIV - Human Immunodeficiency Virus All trials for Hepatitis B Virus (HBV) All trials of Cepheid GeneXpert HCV Test All trials of Abbott Determine HIV - 1/2 Ag/Ab
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard of Care (control arm) | Active comparator | Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] | Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV. |
| Single-visit POC test & treat (intervention arm) | Experimental | Device: Cepheid GeneXpert HCV Test; Device: Abbott Determine HIV - 1/2 Ag/Ab; Device: Abbott Determine HbsAg 2; Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] | Sites randomized to the single-visit point-of-care test (POC) \& treat arm will undergo fingerstick POC HCV RNA, HIV antibody/antigen, and HBsAg and for those with detectable HCV RNA, HCV treatment will be initiated. |
Sex: All, ages: 16 Years to any
Inclusion Criteria: 1. Can provide written informed consent or assent 2. Minimum of 16 years of age 3. Willing to undergo HIV, HCV, HBV testing 4. Willing to undergo treatment for HCV and complete study activities Exclusion Criteria: 1. History of HCV treatment for current infection 2. 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 3. 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. 4. 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 5. 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. Retreatment Inclusion Criteria: 1. 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. 2. 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 Retreatment Exclusion Criteria: 1. 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. 2. Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir. 3. Contraindication for treatment with sofosbuvir/velpatasvir (reinfection) or sofosbuvir/velpatasvir/voxilaprevir (relapse or virologic failure) due to FDA package insert, allergy, or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry. 4. 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 5. 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.
NIH grants: U01AI195193