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CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

NCT02402218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2020-04-14

Study results available
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Summary

This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks. The study population is persons living with HIV and hepatitis C virus (HCV) coinfection who also use drugs. Participants will be randomized into one of three treatment groups:

1. Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team.
2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
3. Usual care plus incentives. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain treatment goals during the course of the study.

HCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.

Conditions

  • Hepatitis C Virus Infection, Response to Therapy of
  • Human Immunodeficiency Virus

Interventions

OTHER

Usual care plus peer-mentors

Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.

OTHER

Usual care plus incentives

Participants are given incentives after completing treatment goals.

OTHER

Usual Care

Participants receive standard of care in the clinic from their health care team.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Mark Sulkowski, MD · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-01-04
Completion
2017-06-21

Countries

  • United States

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 NCT02402218 on ClinicalTrials.gov