Rural New England Health Study (Phase 2)

Description

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.

Conditions

Hepatitis C, Opioid Use Disorder, IV Drug Usage

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Study Overview

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Study Details

Study overview

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.

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

Rural New England Health Study (Phase 2)

Condition
Hepatitis C
Intervention / Treatment

-

Contacts and Locations

Keene

Mobile Study Van, Keene, New Hampshire, United States, 03431

Bennington

Mobile Study Van, Bennington, Vermont, United States, 05201

Brattleboro

Mobile Study Van, Brattleboro, Vermont, United States, 05301

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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:

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Baystate Medical Center,

Peter D Friedmann, MD, MPH, PRINCIPAL_INVESTIGATOR, Baystate Medical Center

Thomas J Stopka, PhD, MHS, PRINCIPAL_INVESTIGATOR, Tufts University

Study Record Dates

2024-07-31