RECRUITING

Rural New England Health Study (Phase 2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-18
Study Completion:2024-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05466331

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Current or past history of drug injection;
  2. 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. 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. 4. Age 18 years or older;
  5. 5. Speaks English;
  6. 6. Capacity to voluntarily provide informed consent;
  7. 7. Will accept randomized assignment, and participate in follow-up over 12 months;
  8. 8. Will provide releases to access community medical records;
  9. 9. Will provide names and contact information of at least 3 persons for re-contact purposes;
  10. 10. Not previously treated for HCV;
  11. 11. Not pregnant or trying to conceive;
  12. 12. HCV antibody positive on point-of-care rapid test.
  1. 1. Unable to obtain venous blood sample for mandatory laboratory testing
  2. 2. HCV viral load undetectable
  3. 3. Hepatitis B surface antigen (HBsAg) positive;
  4. 4. Significant renal failure (eGFR 30 mL/min/1.73m2 or less, or end-stage renal disease requiring dialysis);
  5. 5. Decompensated cirrhosis, as manifested by liver fibrosis on elastography (FibroScan) and/or Fibrosure blood test plus at least one of the following symptoms:

Contacts and Locations

Study Contact

Randall A Hoskinson
CONTACT
413-794-7034
randall.hoskinson@baystatehealth.org
Lizbeth Del Toro-Mejias
CONTACT
787-462-1262
lizbeth.deltoro-mejias@baystatehealth.org

Principal Investigator

Peter D Friedmann, MD, MPH
PRINCIPAL_INVESTIGATOR
Baystate Medical Center
Thomas J Stopka, PhD, MHS
PRINCIPAL_INVESTIGATOR
Tufts University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

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 Registration Dates

Study Start Date2022-05-18
Study Completion Date2024-07-31

Study Record Updates

Study Start Date2022-05-18
Study Completion Date2024-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hepatitis C
  • Opioid Use Disorder
  • IV Drug Usage