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| ID | Type | Description | Link |
|---|---|---|---|
| UH3DA044830 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Tufts University | OTHER |
| University of New Hampshire | OTHER |
| University of Vermont | OTHER |
| Dartmouth-Hitchcock Medical Center |
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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.
This study will employ a randomized, parallel-group design to determine the best strategy for mobile testing-and-treatment of rural opioid users for HCV. This Type 1 hybrid effectiveness-implementation study will examine the effectiveness of a model of mobile telemedicine service delivery integrated into rural harm reduction programming. The model aims to reach rural opioid injectors who are living with HCV and to fill service gaps identified in previous work around access to syringe services and HCV testing and treatment. Working closely with local harm reduction agencies, this study will employ a mobile van to expand antibody and viral load testing for HCV, distribute syringes in rural communities with poor access to brick-and-mortar syringe service providers, and provide HCV telemedicine treatment. The study will also replicate prior validation of the accuracy of dried blood spot (DBS) testing for HCV viral load as a potential strategy to address limited access to effective phlebotomy. All consenting volunteers with HCV antibody present will receive HCV viral load and liver elastography results, and, if current HCV carriers, initial vaccination for HBV and/or HAV. Participants with current HCV will be randomized to one of two intervention arms for HCV work-up and care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Tele-HCV Care | Experimental | Direct Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine |
|
| Enhanced Usual Care | Active Comparator | Referral with care navigation to a local or regional HCV treatment provider |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Tele-HCV Care | Other | Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Randall A Hoskinson | Contact | 413-794-7034 | randall.hoskinson@baystatehealth.org | |
| Lizbeth Del Toro-Mejias | Contact | 787-462-1262 | lizbeth.deltoro-mejias@baystatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Peter D Friedmann, MD, MPH | Baystate Medical Center | Principal Investigator |
| Thomas J Stopka, PhD, MHS | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Study Van | Recruiting | Keene | New Hampshire | 03431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41742143 | Derived | Nolte K, Del Toro-Mejias L, Bianchet E, Tarplin S, Hoskinson R, Friedmann PD, Stopka TJ. Convenience, rapport and skill: effective rural hepatitis C treatment, qualitative findings from a mobile harm reduction-informed tele-medicine intervention in Northern New England, 2022-2024. Harm Reduct J. 2026 Feb 25;23(1):68. doi: 10.1186/s12954-026-01421-1. | |
| 41587029 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 23, 2025 | |
| Reset | Nov 6, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 23, 2025 | Nov 6, 2025 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| OTHER |
| Better Life Partners Inc | UNKNOWN |
| National Institute on Drug Abuse (NIDA) | NIH |
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| Enhanced Usual Care | Other | Study participants are referred to a clinician in their area for HCV care. |
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| Mobile Study Van | Recruiting | Bennington | Vermont | 05201 | United States |
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| Mobile Study Van | Recruiting | Brattleboro | Vermont | 05301 | United States |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |