Clinical trial NCT05466331: Rural New England Health Study (Phase 2)
Official title: Drug Injection Surveillance and Care Enhancement for Rural Northern New England (UH3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C
Opioid Use Disorder
IV Drug Usage
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: Tufts University
name: University of New Hampshire
name: University of Vermont
name: Dartmouth-Hitchcock Medical Center
name: Better Life Partners Inc
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-07-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment initiation
timeFrame: 16 weeks post-enrollment
measure: Sustained virologic response
timeFrame: 12 weeks post-treatment
measure: Syringe sharing
timeFrame: 24 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Keene
country: United States
facility: Mobile Study Van
state: New Hampshire
city: Bennington
country: United States
facility: Mobile Study Van
state: Vermont
city: Brattleboro
country: United States
facility: Mobile Study Van
state: Vermont
Study officials:
affiliation: Baystate Medical Center
name: Peter D Friedmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts University
name: Thomas J Stopka, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
References: