Mobile hepatitis C testing and treatment for rural opioid users

Drug Injection Surveillance and Care Enhancement for Rural Northern New England (UH3)

This study is testing whether a mobile service that offers hepatitis C testing and treatment can help rural opioid users get the care they need and reduce sharing of syringes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baystate Medical Center (other)
• Locations: 3 sites (Keene, New Hampshire and 2 other locations)
• Trial ID: NCT05466331 on ClinicalTrials.gov

What this trial studies

This study integrates mobile hepatitis C virus (HCV) testing and treatment with expanded syringe access to improve HCV testing uptake and reduce syringe sharing among rural opioid injectors in northern New England. Utilizing a randomized, parallel-group design, the study will assess the effectiveness of a mobile telemedicine service delivery model combined with harm reduction programming. Participants will receive HCV testing, treatment, and education through a mobile van, addressing service gaps in rural areas. The study also aims to validate the use of dried blood spot testing for HCV viral load as a solution for limited access to traditional blood sampling methods.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older with a current or past history of drug injection, living in specific counties in New Hampshire and Vermont, and who are HCV antibody positive.

Not a fit: Patients who have previously been treated for HCV or have undetectable HCV viral loads will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve access to HCV testing and treatment for rural opioid users, ultimately reducing HCV and HIV transmission rates.

How similar studies have performed: Previous studies have shown promise in mobile health interventions for HCV, but this specific approach integrating telemedicine with syringe services is relatively novel.

Eligibility criteria

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.

Where this trial is running

Keene, New Hampshire and 2 other locations

• Mobile Study Van — Keene, New Hampshire, United States (RECRUITING)
• Mobile Study Van — Bennington, Vermont, United States (RECRUITING)
• Mobile Study Van — Brattleboro, Vermont, United States (RECRUITING)

Study contacts

• Principal investigator: Peter D Friedmann, MD, MPH — Baystate Medical Center
• Study coordinator: Randall A Hoskinson

Conditions: Hepatitis C, Opioid Use Disorder, IV Drug Usage