Combating Related Epidemics in HCV

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)

Interventions

DEVICE

Cepheid GeneXpert HCV Test

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.

DEVICE

Abbott Determine HIV - 1/2 Ag/Ab

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.

DEVICE

Abbott Determine HbsAg 2

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.

DRUG

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

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.

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• West Virginia University

  collaborator OTHER

• University of San Diego

  collaborator OTHER

• Cepheid

  collaborator INDUSTRY

• Gilead Sciences

  collaborator INDUSTRY

• Abbott

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Flinders University International Centre for Point-of-care Testing

  collaborator UNKNOWN

• Kirby Institute

  collaborator OTHER_GOV

• Duke University

  lead OTHER

Principal Investigators

• Susanna Naggie, MD, MHS · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2030-11-30

Completion

2030-12-30

FDA Drug

Yes

FDA Device

Yes