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Rural New England Health Study (Phase 2) (DISCERNNE)

Primary Purpose

Hepatitis C, Opioid Use Disorder, IV Drug Usage

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mobile Tele-HCV Care

Enhanced Usual Care

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Current or past history of drug injection;
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)
Lives in one of the 10 study counties in NH and VT, and plans to remain in the study region for the next 12 months;
Age 18 years or older;
Speaks English;
Capacity to voluntarily provide informed consent;
Will accept randomized assignment, and participate in follow-up over 12 months;
Will provide releases to access community medical records;
Will provide names and contact information of at least 3 persons for re-contact purposes;
Not previously treated for HCV;
Not pregnant or trying to conceive;
HCV antibody positive on point-of-care rapid test.

Exclusion Criteria:

Unable to obtain venous blood sample for mandatory laboratory testing
HCV viral load undetectable
Hepatitis B surface antigen (HBsAg) positive;
Significant renal failure (eGFR 30 mL/min/1.73m2 or less, or end-stage renal disease requiring dialysis);
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.

Sites / Locations

Mobile Study VanRecruiting
Mobile Study VanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Tele-HCV Care

Enhanced Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment initiation

Proportion of participants who initiate DAA treatment

Sustained virologic response

Proportion of participants who achieve sustained virologic response at 12 weeks post-treatment

Syringe sharing

Proportion of participants who report no syringe sharing in the prior 30 days at follow-up

Secondary Outcome Measures

Full Information

NCT ID

NCT05466331

First Posted

June 13, 2022

Last Updated

July 18, 2022

Sponsor

Baystate Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05466331

Brief Title

Rural New England Health Study (Phase 2)

Acronym

DISCERNNE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 18, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baystate Medical Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Opioid Use Disorder, IV Drug Usage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mobile Tele-HCV Care

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced Usual Care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Mobile Tele-HCV Care

Intervention Description

Study participants receive HCV care via telemedicine. Telemedicine appointments are performed on a mobile van.

Intervention Type

Other

Intervention Name(s)

Enhanced Usual Care

Intervention Description

Study participants are referred to a clinician in their area for HCV care.

Primary Outcome Measure Information:

Title

Treatment initiation

Description

Proportion of participants who initiate DAA treatment

Time Frame

16 weeks post-enrollment

Title

Sustained virologic response

Description

Proportion of participants who achieve sustained virologic response at 12 weeks post-treatment

Time Frame

12 weeks post-treatment

Title

Syringe sharing

Description

Proportion of participants who report no syringe sharing in the prior 30 days at follow-up

Time Frame

24 weeks post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current or past history of drug injection; 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) Lives in one of the 10 study counties in NH and VT, and plans to remain in the study region for the next 12 months; Age 18 years or older; Speaks English; Capacity to voluntarily provide informed consent; Will accept randomized assignment, and participate in follow-up over 12 months; Will provide releases to access community medical records; Will provide names and contact information of at least 3 persons for re-contact purposes; Not previously treated for HCV; Not pregnant or trying to conceive; HCV antibody positive on point-of-care rapid test. Exclusion Criteria: Unable to obtain venous blood sample for mandatory laboratory testing HCV viral load undetectable Hepatitis B surface antigen (HBsAg) positive; Significant renal failure (eGFR 30 mL/min/1.73m2 or less, or end-stage renal disease requiring dialysis); 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Randall A Hoskinson

Phone

413-794-7034

randall.hoskinson@baystatehealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Lizbeth Del Toro-Mejias

Phone

787-462-1262

lizbeth.deltoro-mejias@baystatehealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter D Friedmann, MD, MPH

Organizational Affiliation

Baystate Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas J Stopka, PhD, MHS

Organizational Affiliation

Tufts University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mobile Study Van

City

Keene

State/Province

New Hampshire

ZIP/Postal Code

03431

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Randall A Hoskinson

Phone

413-794-7034

ruralnehealthstudy@baystatehealth.org

First Name & Middle Initial & Last Name & Degree

Lizbeth Del Toro-Mejias

Phone

413-794-4041.

ruralnehealthstudy@baystatehealth.org

Facility Name

Mobile Study Van

City

Brattleboro

State/Province

Vermont

ZIP/Postal Code

05301

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Randall Hoskinson

Phone

413-794-7034

ruralNEhealthstudy@bhs.org

First Name & Middle Initial & Last Name & Degree

Lizbeth Del Toro-Mejias

Phone

413-794-4041

ruralNEhealthstudy@bhs.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Rural New England Health Study (Phase 2)

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