Rural New England Health Study (Phase 2)
This study will integrate mobile hepatitis C virus (HCV) testing and treatment with expanded syringe access in order to improve uptake of HCV testing and treatment, and reduce syringe sharing behavior in rural northern New England. The intervention aims to reach rural opioid injectors with HCV and to fill service gaps identified around access to syringe services and HCV testing and treatment, while limiting the burden on local partners. If effective, this mobile model of HCV telehealth integrated with syringe services will provide a promising approach for local public health authorities seeking to curb opioid injection, syringe sharing and HCV rates in rural America, and reduce the risk environment for HIV outbreaks in those communities.
Conditions:
🦠 Hepatitis C 🦠 Opioid Use Disorder 🦠 IV Drug Usage
🗓️ Study Start (Actual) 18 May 2022
🗓️ Primary Completion (Estimated) 31 July 2024
✅ Study Completion (Estimated) 31 July 2024
👥 Enrollment (Estimated) 220
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Keene, New Hampshire, United States
📍 Bennington, Vermont, United States
📍 Brattleboro, Vermont, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Current or past history of drug injection;
    • 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:

    • 1. Unable to obtain venous blood sample for mandatory laboratory testing
    • 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 June 2022
  • First Submitted that Met QC Criteria 18 July 2022
  • First Posted 20 July 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 November 2023
  • Last Update Posted 1 December 2023
  • Last Verified November 2023