NCT05466331

Rural New England Health Study (Phase 2)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Baystate Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C
• Opioid Use Disorder
• IV Drug Usage

Interventions

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

Timeline

• Start date: 2022-05-18
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2022-07-20
• Last updated: 2023-12-01

Locations

3 sites across 1 country: United States