Hepatitis CDISCERNNENCT05466331
Rural New England Health Study (Phase 2)
A study testing Mobile Tele-HCV Care in people with Hepatitis C and Opioid Use Disorder, run by Baystate Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Opioid Use Disorder, IV Drug Usage
- What is being tested?
- Mobile Tele-HCV Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 May 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
- 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:
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Mobile Study Van
Bennington, Vermont, 05201
Randall Hoskinson, 413-794-7034, ruralNEhealthstudy@baystatehealth.org
Lizbeth DelToro-Mejias, 413-794-4041, ruralNEhealthstudy@baystatehealth.org
- Recruiting
Mobile Study Van
Brattleboro, Vermont, 05301
Randall Hoskinson, 413-794-7034, ruralNEhealthstudy@bhs.org
Lizbeth Del Toro-Mejias, 413-794-4041, ruralNEhealthstudy@bhs.org
- Recruiting
Mobile Study Van
Keene, New Hampshire, 03431
Randall A Hoskinson, 413-794-7034, ruralNEhealthstudy@baystatehealth.org
Lizbeth Del Toro-Mejias, 413-794-4041., ruralNEhealthstudy@baystatehealth.org
About this study
Official title: Drug Injection Surveillance and Care Enhancement for Rural Northern New England (UH3)
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.
Read the detailed description
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.
- Conditions
- Hepatitis C, Opioid Use Disorder, IV Drug Usage
- Being tested
- Mobile Tele-HCV Care, Enhanced Usual Care
- Medical subject headings
- Hepatitis C, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Tele-HCV CareOther
Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van.
Enhanced Usual CareOther
Study participants are referred to a clinician in their area for HCV care.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Tele-HCV Care | Experimental | Direct Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine Receives: Other: Mobile Tele-HCV Care |
| Enhanced Usual Care | Active comparator | Referral with care navigation to a local or regional HCV treatment provider Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment initiation
Proportion of participants who initiate DAA treatment
Measured: 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.
Measured: 12 weeks post-treatment
Syringe sharing
Proportion of participants who report no syringe sharing in the prior 30 days at follow-up
Measured: 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start18 May 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University, University of New Hampshire, University of Vermont, Dartmouth-Hitchcock Medical Center, Better Life Partners Inc, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Peter D Friedmann, MD, MPH, Principal investigator, Baystate Medical CenterThomas J Stopka, PhD, MHS, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466331
- Sponsor's protocol ID
- BH19-166
- Other IDs
- UH3DA044830
- Acronym
- DISCERNNE
- Status last verified
- Nov 2023
- First submitted
- 13 Jun 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41742143Friedmann 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.
PubMed 41587029
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Injection Surveillance and Care Enhancement for Rural Northern New England (UH3)
- ClinicalTrials.gov ID
- NCT05466331
- Acronym / sponsor ID
- DISCERNNE / BH19-166
- Conditions
- Hepatitis C, Opioid Use Disorder, IV Drug Usage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Collaborators
- Tufts University, University of New Hampshire, University of Vermont, Dartmouth-Hitchcock Medical Center, Better Life Partners Inc, National Institute on Drug Abuse (NIDA)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Tele-HCV Care | Experimental | Other: Mobile Tele-HCV CareDirect Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareReferral with care navigation to a local or regional HCV treatment provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Tele-HCV CareStudy participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van. | Other | Mobile Tele-HCV Care |
| Enhanced Usual CareStudy participants are referred to a clinician in their area for HCV care. | Other | Enhanced Usual Care |
Primary outcome
Treatment initiation
Time frame: 16 weeks post-enrollment
Proportion of participants who initiate DAA treatment
Sustained virologic response
Time frame: 12 weeks post-treatment
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.
Syringe sharing
Time frame: 24 weeks post-treatment
Proportion of participants who report no syringe sharing in the prior 30 days at follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 41742143Nolte 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.
- Derived from this study: PubMed 41587029Friedmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter D Friedmann, MD, MPH principal investigator
Baystate Medical Center
Thomas J Stopka, PhD, MHS principal investigator
Tufts University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Tele-HCV Care in people with Hepatitis C and Opioid Use Disorder, run by Baystate Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randall A Hoskinson (413-794-7034, randall.hoskinson@baystatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment initiation (time frame: 16 weeks post-enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.