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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBMI intervention group | Other | All patients will receive a 12 week VBMI intervention to promote treatment completion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBMI | Behavioral | 12 week values based motivational interviewing intervention with a licensed psychologist |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Completion | Number of participants who completed treatment | 12 weeks after initiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response | Number of participants who achieved SVR | an average of 3 months after treatment completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Burton, MD | G.V. (Sonny) Montgomery VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GV Sonny Montgomery VAMC | Jackson | Mississippi | 39216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38918869 | Derived | Burton MJ, Voluse AC, Patel AB. Supporting direct acting antiviral medication adherence and treatment completion in a sample of predominantly rural veterans with hepatitis C and substance use disorders. Addict Sci Clin Pract. 2024 Jun 25;19(1):51. doi: 10.1186/s13722-024-00480-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VBMI Intervention Group | All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2019 |
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open label
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VBMI Intervention Group | All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Completion | Number of participants who completed treatment | Posted | Count of Participants | Participants | 12 weeks after initiation treatment |
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| Secondary | Sustained Virologic Response | Number of participants who achieved SVR | Posted | Count of Participants | Participants | an average of 3 months after treatment completion |
|
|
Six months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VBMI Intervention Group | All patients will receive a 12 week VBMI intervention to promote treatment completion VBMI: 12 week values based motivational interviewing intervention with a licensed psychologist | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Jane Burton | GV Sonny Montgomery VAMC | 6013624471 | mary.burton2@va.gov |
| Dec 11, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D019698 | Hepatitis C, Chronic |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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