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HCV Seek, Test and Rapid Treatment for Young PWID | Clinical Trials | Clareo Health

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HCV Seek, Test and Rapid Treatment for Young PWID

A Randomized Study of a Rapid HCV Treatment Initiation Strategy (HCV Seek, Test and Rapid Treatment) Compared to Standard Care in Young People Who Inject Drugs

NCT03627546•Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

The purpose of this randomized study is to determine whether a community-based test and treat model of hepatitis C (HCV) care delivery will be superior to the usual care practice of referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between ages 18 and 29 who are naïve to HCV treatment

Detailed Description

ST\&RT is a randomized open-label clinical trial in which 54 HCV infected PWID between ages 18 and 29 will be randomized to either receive the same-day treatment initiation of the FDA-approved fixed dose combination of sofosbuvir 400mg and velpatasvir 100mg (SOF/VEL) with follow up and medical monitoring at a community site (Intervention arm) or to receive referral to an HCV treatment provider's office (Usual Care Arm).

Eligibility

Age

18 - 29 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Persons are eligible for study inclusion if they: (a) are HCV antibody positive, (b) are 18 to 29 years of age, (c) have injected drugs in the past 30 days, (d) are HCV treatment naïve, (e) are English speaking

Exclusion Criteria

•Persons excluded from the study will be (a) HIV coinfected persons (b) pregnant women, or women planning on becoming pregnant (c) participants with end-stage renal disease (d) participants with decompensated cirrhosis (c) participants on medications with treatment limiting interactions with sofosbuvir/velpatasvir

Locations (1)

Lower East Side Harm Reduction Center

New York, New York, United States

Key Dates

Start Date

September 18, 2018

Primary Completion Date

June 30, 2021

Completion Date

June 30, 2021

Last Updated

April 29, 2024

Enrollment

ACTUAL participants

Conditions

Hepatitis CDrug Use

Interventions

Rapid Treatment strategy

OTHER

Usual Care (facilitated referral)

OTHER

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

NCT07199335

HIVSubstance Use Disorder (SUD)+1 more

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RECRUITINGPHASE4

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HCV Seek, Test and Rapid Treatment for Young PWID

Inclusion Criteria

Exclusion Criteria

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

Effectiveness of ACT for Problematic Chemsex

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use