HCV Test and Treat Utilizing Simplified HCV Patient Education

Part of paid clinical trials in Long Island City, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05582681
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Cepheid POC HCV Viremia (RNA) test — DIAGNOSTIC_TEST
    The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is a test designed for the quantitation (amount) of Hepatitis C Virus (HCV) DNA in human whole blood. The HCV RNA result will be compared to standardized laboratory assessment for HCV Viremia. The Cepheid test is for being conducted for research use only and will not be used for HCV diagnosis or treatment decisions.
  • HCV education from a health care provider — OTHER
    HCV education provided by health care provider. HCV Education will include HCV disease overview, HCV screening, treatment with G/P, and post treatment assessment and management
  • Glecaprevir and Pibrentasvir — DRUG
    G/P will be provided for 8 weeks.

Study Details

The study hypothesis is that the test and treat model utilizing video-based patient education will have higher rates of hepatitis C virus (HCV) treatment initiation and treatment completion.

Key Dates

Start date
Nov 11, 2022
Status verified
Feb 2025
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: HCV Education
    The intervention of HCV education will be performed at the addiction care setting for video- based patient education. Health care provide delivered patient education is the standard of care referral approach. HCV Education will include HCV disease overview, HCV screening, taking Glecaprevir/Pibrentasivir (G/P), and post study drug assessment and management. Participants may be randomized to either the video-based patient education or the HCV delivered patient education.
  • Experimental: Point of Care (POC) HCV Viremia (RNA) testing
    All participants will have standardized laboratory assessments for HCV Viremia (RNA testing) as well as Cepheid POC HCV Viremia (RNA) test. The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is a test designed for the quantitation (amount) of Hepatitis C Virus (HCV) DNA in human whole blood. The HCV RNA result will be compared to standardized laboratory assessment for HCV Viremia. The Cepheid test is being conducted for research use only and will not be used for HCV diagnosis or treatment decisions.

Primary Outcome Measure

Number of subjects who initiated treatment within 8-week window from enrollment. [ Time Frame: Up to 8 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Phoenix HouseLong Island CityNew York11101-
ColumbiaDoctors MidtownNew YorkNew York10019-
Weill Cornell Medicine Midtown Center for Treatment and ResearchNew YorkNew York10036-

Find similar trials in Long Island City, NY

By research site
Phoenix House· Long Island City, NYColumbiaDoctors Midtown· New York, NYWeill Cornell Medicine Midtown Center for Treatment and Research· New York, NY

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