Recruiting

Observational Study

Sponsor:

Baystate Medical Center

Code:

NCT05466331

Conditions

Hepatitis C

Opioid Use Disorder

IV Drug Usage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mobile Tele-HCV Care

Enhanced Usual Care

Study Details

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.

Conditions

Hepatitis C

Opioid Use Disorder

IV Drug Usage

Study ID

NCT05466331

Start date

May 18, 2022

Status verified date

Nov, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mobile Tele-HCV Care

Direct Acting Antiviral (DAA) treatment for HCV on a mobile van via telemedicine

active comparator: Enhanced Usual Care

Referral with care navigation to a local or regional HCV treatment provider

Interventions

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.

Primary outcome measure

  • Treatment initiation [ Time Frame: 16 weeks post-enrollment ]
  • Sustained virologic response [ Time Frame: 12 weeks post-treatment ]
  • Syringe sharing [ Time Frame: 24 weeks post-treatment ]

Central Contacts and Locations

Locations

Mobile Study Van

Recruiting

Keene, New Hampshire, United States, 03431

Contacts

Mobile Study Van

Recruiting

Bennington, Vermont, United States, 05201

Contacts

Mobile Study Van

Recruiting

Brattleboro, Vermont, United States, 05301

Contacts

More Information

Sponsor

Baystate Medical Center

Last update posted

Dec 1, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2023-12-01.