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Rapid HCV Treatment Access for Persons Who Use Drugs

NCT04677153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2026-04-13

Study results available
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Summary

This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups:

1. Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection.
2. Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.

Conditions

  • Hepatitis C Virus Infection, Response to Therapy of

Interventions

OTHER

Test and treat plus peer mentors

Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.

OTHER

Usual care

Participants are referred to another location for HCV treatment.

Sponsors & Collaborators

Principal Investigators

  • Oluwaseun Falade-Nwulia, MBBS, MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2024-02-23
Completion
2024-09-23

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677153 on ClinicalTrials.gov