CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

Study Overview
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Brief Summary
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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: Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team. 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. 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.

Detailed Description
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Recent advances in Hepatitis C Virus (HCV) treatment represent a paradigm shift for the treatment of HCV-infected persons with Human Immunodeficiency Virus (HIV) coinfection. With potent antiviral activity, excellent safety/tolerability, few drug interactions and once daily, oral dosing, Sofosbuvir (SOF)/Ledipasvir (LDV) have had excellent efficacy in randomized controlled trials and offer great promise for the treatment of hepatitis C in HIV/HCV coinfected patients who are at high risk for progressive liver disease and HCV-related mortality. While the availability of SOF/LDV has great promise for the treatment of patients, the experience with antiretroviral therapy (ART) for the treatment of HIV infection indicates that interferon-free oral therapy is necessary but not sufficient to cure HCV in the real world. While removal of Interferon increases the proportion of coinfected persons who use drugs (PWUD) eligible for treatment, multiple barriers will remain (e.g., medical/psychiatric illness, substance abuse, and social constraints). Effective ART in coinfected PWUDs provides a strategic framework for the delivery of curative HCV treatment; novel and effective strategies for delivering this care for HCV must be evaluated, including incentives and peer-mentoring. Financial incentives. One method for increasing delivery of care is the contingent administration of monetary incentives; such reinforcements have improved health outcomes related to drug/alcohol abstinence, smoking cessation, childhood vaccination, tuberculosis care and HIV treatment. Contingent reinforcement has also been successfully used to link HIV-infected patients to care and improve adherence to ART. Curative HCV treatments are given for a finite duration (12 weeks) which offers an ideal paradigm for incentive interventions by reducing the overall cost and removing concerns of loss of adherence if incentives are stopped. Peer support. A second method for improving delivery of care is the use of peers or laypersons with the same illness. By matching on cultural competencies and establishing trust, peers may be particularly effective in some settings. In one study, African American veterans with poorly controlled diabetes assigned to peer-support had better glucose control than those assigned financial incentives. Coinfected patients may benefit from peer support. The investigators will test two innovative strategies to improve HCV treatment outcomes in HIV/HCV coinfected patients through the delivery of SOF/LDV for 12 weeks as part of a randomized controlled trial. HIV-infected patients will receive SOF/LDV under one of three randomly assigned conditions: usual care (clinic-based nursing model), incentive care (IC) or peer-mentor care (PMC).

Official Title
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CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS

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

Intervention / Treatment
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* Other: Usual care plus peer-mentors
* Other: Usual care plus incentives
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or greater Hepatitis C genotype 1 infection for at least 6 months No evidence of Hepatocellular Carcinoma or End-Stage Liver Disease (e.g., history of ascites, bleeding varices, and/or encephalopathy) Cluster of Differentiation 4 (CD4) cell count > 100 cells/mm3 for more than 3 months HIV RNA positive for more than 3 months Ability to communicate effectively with key study personnel Willing to give written informed consent and comply with the study requirements Life expectancy > 2 year Exclusion Criteria: Currently receiving Hepatitis C treatment Renal insufficiency - estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: <30 mL/min/1.73 m2 Antiretroviral therapy inclusive of STRIBILD or APTIVUS Inability or unwillingness to avoid pregnancy for woman of child-bearing potential and/or to father children during treatment and for a period of 3 months following completion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Participants receive standard of care for Hepatitis C in the clinic. | Other: Usual Care<br>* Participants receive standard of care in the clinic from their health care team.<br>|
| Experimental: Usual care plus peer-mentors<br>In addition to receiving standard of care for HCV in the clinic, 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. | Other: Usual care plus peer-mentors<br>* Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.<br>|
| Experimental: Usual care plus incentives<br>In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study. | Other: Usual care plus incentives<br>* Participants are given incentives after completing treatment goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Initiated HCV Therapy by Intervention Group | The percentage of participants who initiated HCV therapy [Ledipasvir/Sofosbuvir (LDV/SOF)] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC). | at week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) Following Treatment by Intervention Group | The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen | at post-treatment week 12 | 
| Number of Participants With Adverse Events During HCV Treatment by Intervention Group | Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group | at post-treatment week 12 | 
| Change in Alcohol Use by Blood Test During HCV Treatment | Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6 | Pre-treatment and at treatment week 6 | 
| Change in Illicit Drug Use During HCV Treatment | Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6 | Pre-treatment and at treatment week 6 | 
| Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group | Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus. | at post-treatment week 12 |