Combating Related Epidemics in HCV

NCT07560046 | Not Yet Recruiting Phase 4 DMC FDA Drug FDA Device

• 2 other identifiers: Pro001188631U01AI195193
• Study Type: interventional
• Target: 1,280
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV - Human Immunodeficiency Virus; Hepatitis B Virus (HBV); HEPATITIS C (HCV)

Keywords

Hepatitis C; Hepatitis B; HIV; CREST

Outcome Measures

Primary Outcomes (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.

  Proportion of participants in the primary analysis population (as defined as detectable HCV RNA on dried blood spot testing at screening) who complete the HCV care cascade within 24 weeks of study entry in intervention versus SOC arm. Completion of the care cascade will be defined as HCV RNA\<lower limit of quantification/detection (LLOQ/D) at a minimum of 4 weeks post-cessation of direct-acting antiviral (DAA) therapy sustained virologic response (SVR4+).

  24 weeks from study enrollment

Secondary Outcomes (20)

• Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only)

  Day 1

• Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry

  12 weeks

• Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry

  24

• Time from enrollment to treatment initiation

  up to 24 weeks

• Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry

  24 weeks

Other Outcomes (5)

• Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report

  12 and 24 weeks

• Health-related quality of life (EQ5D) and social functioning through week 60

  Week 60

• Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60

  from baseline to Week 24 and 60

Study Arms (2)

Standard of Care (control arm)

ACTIVE COMPARATOR

Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV.

Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Single-visit POC test & treat (intervention arm)

EXPERIMENTAL

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.

Device: Cepheid GeneXpert HCV Test; Device: Abbott Determine HIV - 1/2 Ag/Ab; Device: Abbott Determine HbsAg 2; Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Interventions

Cepheid GeneXpert HCV Test DEVICE

Cepheid Xpert HCV Test, performed on the GeneXpert Xpress system, in an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of Hep C (HCV) RNA in human fingerstick.

Single-visit POC test & treat (intervention arm)

Abbott Determine HIV - 1/2 Ag/Ab DEVICE

Abbott Determine HIV - 1/2 Ag/Ab combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus type-1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV type-1 and type-2 in fingerstick. Intended use is point-of-care test to aid in the diagnosis of infection.

Single-visit POC test & treat (intervention arm)

Abbott Determine HbsAg 2 DEVICE

Determine HBsAg 2 is an in vitro, visually read, qualitative immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human fingerstick. The test is intended as an aid to detect HBAg from infected individuals.

Single-visit POC test & treat (intervention arm)

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] DRUG

Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.

Also known as: Direct acting antiviral

Single-visit POC test & treat (intervention arm); Standard of Care (control arm)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir.
• 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.
• 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.

Sponsors & Collaborators

• Duke University: lead
• Yale University: collaborator
• West Virginia University: collaborator
• University of San Diego: collaborator
• Cepheid: collaborator
• Gilead Sciences: collaborator
• Abbott: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Flinders University International Centre for Point-of-care Testing: collaborator
• Kirby Institute: collaborator

Related Publications (28)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis B; Hepatitis C

Interventions

Sofosbuvir; velpatasvir; sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Susanna Naggie, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04