VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C

Study Overview
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Brief Summary
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This study implement a values-based motivational interviewing (VBMI) intervention to promote treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30 Veterans with substance use disorder (SUD) and treatment naïve genotype 1 chronic hepatitis C virus (HCV) infection.

Detailed Description
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The investigators will conduct a prospective study of 30 Veterans with treatment-naive genotype 1 chronic hepatitis C infection admitted to the Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) at the G.V. (Sonny) Montgomery VA Medical Center. Enrolled veterans will be treated MK-5172/MI-8742 while receiving a 12 week values based motivational intervention to promote completion of HCV treatment. MK-5172/MK-8742 will be prescribed in accordance with the package insert.

Official Title
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Evaluating Values-based Motivational Interviewing to Increase Treatment Completion With Fixed Dose Combination MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders and Treatment-naïve Genotype 1 Chronic Hepatitis C

Conditions
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Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders

Intervention / Treatment
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* Behavioral: VBMI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who are genotype 1a must have baseline NS5a resistance testing Current resident of the SARRTP program Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days post-discharge. Willing to attend coordinated HCV treatment clinic visits and substance abuse aftercare visits every 2 weeks upon SARRTP discharge Exclusion Criteria: Contraindications for therapy with FDC MK-5172/MK-8742 Unable to provide written informed consent Hepatocellular carcinoma or other medical condition precluding HCV treatment Acute HCV infection Prior treatment for chronic HCV History of decompensated cirrhosis Platelet count < 75 K/cmm and/or albumin < 3 grams/dL Females and male sex partners of females who are pregnant, nursing and/or unwilling to use contraception Patients infected with genotype 1a who have not undergone baseline NS5a resistance testing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VBMI intervention group<br>All patients will receive a 12 week VBMI intervention to promote treatment completion | Behavioral: VBMI<br>* 12 week values based motivational interviewing intervention with a licensed psychologist<br>* Other names: Values Based Motivational Interviewing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Completion | Number of participants who completed treatment | 12 weeks after initiation treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response | Number of participants who achieved SVR | an average of 3 months after treatment completion |