Rural New England Health Study (Phase 2) (DISCERNNE)

November 28, 2023 updated by: Baystate Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Tele-HCV Care
Direct Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine
Other: Mobile Tele-HCV Care
Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van.
Active Comparator: Enhanced Usual Care
Referral with care navigation to a local or regional HCV treatment provider
Other: Enhanced Usual Care
Study participants are referred to a clinician in their area for HCV care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment initiation
Time Frame: 16 weeks post-enrollment
Proportion of participants who initiate DAA treatment
16 weeks post-enrollment
Syringe sharing
Time Frame: 24 weeks post-treatment
Proportion of participants who report no syringe sharing in the prior 30 days at follow-up
24 weeks post-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.
12 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baystate Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)
Tufts University
Dartmouth-Hitchcock Medical Center
University of Vermont
University of New Hampshire
Better Life Partners Inc

Investigators

  • Principal Investigator: Peter D Friedmann, MD, MPH, Baystate Medical Center
  • Principal Investigator: Thomas J Stopka, PhD, MHS, Tufts University

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 Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH19-166
  • UH3DA044830 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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