CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
Usual care plus peer-mentors +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02402218
NCT02402218N/ACompleted

CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

Johns Hopkins University·interventional·Posted Mar 30, 2015·Updated Apr 14, 2020

In Brief

A clinical study evaluating Usual care plus peer-mentors, Usual care plus incentives, and 1 other intervention for Hepatitis C Virus Infection, Response to Therapy of and Human Immunodeficiency Virus. Completed, enrolled 144 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 30, 2015
Enrollment StartAug 1, 2015
Primary CompletionJan 4, 2017
Study CompletionJun 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.3 years ago

Interventions

Usual care plus peer-mentorsother

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

Usual care plus incentivesother

Participants are given incentives after completing treatment goals.

Usual Careother

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