Rural New England Health Study (Phase 2)

Hepatitis C Clinical Trial

— DISCERNNE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466331
• Other study ID #: BH19-166
• Secondary ID: UH3DA044830
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Baystate Medical Center
• Contact: Randall A Hoskinson
• Phone: 413-794-7034
• Email: randall.hoskinson[@]baystatehealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• IV Drug Usage
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• Mobile Tele-HCV Care
Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van.
• Enhanced Usual Care
Study participants are referred to a clinician in their area for HCV care.

Locations

Country	Name	City	State
United States	Mobile Study Van	Bennington	Vermont
United States	Mobile Study Van	Brattleboro	Vermont
United States	Mobile Study Van	Keene	New Hampshire

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

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