Rural New England Health Study (Phase 2)
DISCERNNE
Drug Injection Surveillance and Care Enhancement for Rural Northern New England (UH3)
2 other identifiers
interventional
220
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2022
CompletedFirst Submitted
Initial submission to the registry
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedDecember 1, 2023
November 1, 2023
2.2 years
June 13, 2022
November 28, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Treatment initiation
Proportion of participants who initiate DAA treatment
16 weeks post-enrollment
Sustained virologic response
Proportion of participants who achieve sustained virologic response at 12 weeks post-treatment. Sustained virologic response means that RNA from hepatitis C virus is not detectable in blood samples.
12 weeks post-treatment
Syringe sharing
Proportion of participants who report no syringe sharing in the prior 30 days at follow-up
24 weeks post-treatment
Study Arms (2)
Mobile Tele-HCV Care
EXPERIMENTALDirect Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine
Enhanced Usual Care
ACTIVE COMPARATORReferral with care navigation to a local or regional HCV treatment provider
Interventions
Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van.
Study participants are referred to a clinician in their area for HCV care.
Eligibility Criteria
You may qualify if:
- Current or past history of drug injection;
- 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)
- Lives in one of the study counties in NH and VT, and plans to remain in the study region for the next 12 months;
- Age 18 years or older;
- Speaks English;
- Capacity to voluntarily provide informed consent;
- Will accept randomized assignment, and participate in follow-up over 12 months;
- Will provide releases to access community medical records;
- Will provide names and contact information of at least 3 persons for re-contact purposes;
- Not previously treated for HCV;
- Not pregnant or trying to conceive;
- HCV antibody positive on point-of-care rapid test.
You may not qualify if:
- Unable to obtain venous blood sample for mandatory laboratory testing
- HCV viral load undetectable
- Hepatitis B surface antigen (HBsAg) positive;
- Significant renal failure (eGFR 30 mL/min/1.73m2 or less, or end-stage renal disease requiring dialysis);
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baystate Medical Centerlead
- Tufts Universitycollaborator
- University of New Hampshirecollaborator
- University of Vermontcollaborator
- Dartmouth-Hitchcock Medical Centercollaborator
- Better Life Partners Inccollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
Mobile Study Van
Keene, New Hampshire, 03431, United States
Mobile Study Van
Bennington, Vermont, 05201, United States
Mobile Study Van
Brattleboro, Vermont, 05301, United States
Related Publications (1)
Friedmann PD, Wilson D, de Gijsel D, Nolte K, Dejace J, Hoskinson R Jr, Del Toro-Mejias L, Bianchet E, Dowd P, Soares WE 3rd, Stopka TJ. Mobile Telemedicine for Treating Chronic Hepatitis C Among Rural People Who Inject Drugs: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2555125. doi: 10.1001/jamanetworkopen.2025.55125.
PMID: 41587029DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter D Friedmann, MD, MPH
Baystate Medical Center
- PRINCIPAL INVESTIGATOR
Thomas J Stopka, PhD, MHS
Tufts University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2022
First Posted
July 20, 2022
Study Start
May 18, 2022
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
December 1, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share