Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2022-05-18
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mobile Tele-HCV Care
Direct Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine
Mobile Tele-HCV Care
Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van.
Enhanced Usual Care
Referral with care navigation to a local or regional HCV treatment provider
Enhanced Usual Care
Study participants are referred to a clinician in their area for HCV care.
Interventions
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Mobile Tele-HCV Care
Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van.
Enhanced Usual Care
Study participants are referred to a clinician in their area for HCV care.
Eligibility Criteria
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Inclusion Criteria
2. Health insurance that will cover HCV medications (study staff will work with those who are eligible but have not signed up for insurance prior to study enrollment)
3. Lives in one of the study counties in NH and VT, and plans to remain in the study region for the next 12 months;
4. Age 18 years or older;
5. Speaks English;
6. Capacity to voluntarily provide informed consent;
7. Will accept randomized assignment, and participate in follow-up over 12 months;
8. Will provide releases to access community medical records;
9. Will provide names and contact information of at least 3 persons for re-contact purposes;
10. Not previously treated for HCV;
11. Not pregnant or trying to conceive;
12. HCV antibody positive on point-of-care rapid test.
Exclusion Criteria
2. HCV viral load undetectable
3. Hepatitis B surface antigen (HBsAg) positive;
4. Significant renal failure (eGFR 30 mL/min/1.73m2 or less, or end-stage renal disease requiring dialysis);
5. Decompensated cirrhosis, as manifested by liver fibrosis on elastography (FibroScan) and/or Fibrosure blood test plus at least one of the following symptoms:
i. Observed jaundice (yellowing of the eyes and skin) ii. Self-reported increasing abdominal size (ascites) and leg edema iii. Observed periods of confusion consistent with encephalopathy iv. Self-reported history of gastrointestinal bleeding.
18 Years
ALL
Yes
Sponsors
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Tufts University
OTHER
University of New Hampshire
OTHER
University of Vermont
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Better Life Partners Inc
UNKNOWN
National Institute on Drug Abuse (NIDA)
NIH
Baystate Medical Center
OTHER
Responsible Party
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Principal Investigators
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Peter D Friedmann, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Baystate Medical Center
Thomas J Stopka, PhD, MHS
Role: PRINCIPAL_INVESTIGATOR
Tufts University
Locations
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Mobile Study Van
Keene, New Hampshire, United States
Mobile Study Van
Bennington, Vermont, United States
Mobile Study Van
Brattleboro, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Randall A Hoskinson
Role: primary
Lizbeth Del Toro-Mejias
Role: backup
Randall Hoskinson
Role: primary
Lizbeth DelToro-Mejias
Role: backup
Randall Hoskinson
Role: primary
Lizbeth Del Toro-Mejias
Role: backup
Other Identifiers
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BH19-166
Identifier Type: -
Identifier Source: org_study_id