DBS TaT in Peer-assisted Telemedicine for Hepatitis C

NCT ID: NCT06409169

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2026-05-31

Brief Summary

The purpose of this study is to compare the rate of treatment initiation achieved by peer-assisted telemedicine contingent on phlebotomy (usual care) versus that achieved with a new protocol, called Dried Blood Spot Test and Treat (DBS TaT). DBS TaT includes DBS testing to diagnose hepatitis C (HCV), utilizes a novel clinical decision aid that identifies patients who are low risk for hepatic (liver) fibrosis, and directs those patients to HCV treatment initiation prior to routine hepatic fibrosis assessment.

The investigators hypothesize that DBS TaT will increase the rate of HCV treatment initiation compared to peer-assisted telemedicine contingent on phlebotomy (usual care).

Detailed Description

Oregon has the fourth highest prevalence of hepatitis C (HCV) and third highest HCV-related mortality in the nation and it predominantly effects people who use drugs (PWUD). To respond to this, Peer Assisted Telemedicine for Hepatitis C (PATHS), a Substance Abuse and Mental Health Services Administration supported telemedicine-based HCV treatment program that serve PWUD in predominantly rural areas of Oregon was created. PATHS partners with "peers," people with lived experience of substance use, who work for community-based organizations serving PWUD in high-needs rural counties. Patients are referred to PATHS from opiate treatment programs and community-based organizations throughout the state, which are PATHS' "sites."

The leading barrier to HCV treatment initiation within PATHS is the requirement for participants to complete phlebotomy prior to treatment. To address this problem, PATHS is piloting the use of commercially available, laboratory-validated dried blood spot (DBS) tests to confirm active HCV, but patients who complete DBS must still undergo either phlebotomy or transient elastography (TEG) to complete guideline-recommended hepatic fibrosis staging before HCV treatment. Transient elastography is a validated, non-invasive, clinical standard of hepatic fibrosis assessment covered by Oregon Medicaid, but it is inconvenient to access in rural areas.

This study aims to determine the impact of Dried Blood Spot Test and Treat (DBS TaT) compared to phlebotomy-contingent treatment (usual care) in a cluster randomized controlled trial performed within Peer Assisted Telemedicine for Hepatitis C (PATHS). The primary outcome is the rate of treatment initiation in PATHS sites utilizing DBS TaT versus PATHS sites utilizing usual care. 18 PATHS sites are randomized to DBS TaT implementation or ongoing usual care. Within DBS TaT, participants with low risk for hepatic fibrosis will be offered HCV treatment without phlebotomy but will still undergo imaging-based hepatic fibrosis assessment to ensure safety.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DBS TaT

At DBS TaT sites, peers administer dried blood spot tests to all those interested in HCV screening or treatment. When HCV is diagnosed, peers coordinate a telemedicine visit with a PATHS provider and peer. At the time of the telemedicine visit, a questionnaire, Decompensated Cirrhosis in Hepatitis C Evaluation Questionnaire (DCHEQ), is used to determine risk level of liver fibrosis (liver scaring that is sometimes caused by hepatitis C). Those at low risk for liver fibrosis can start HCV treatment before completing the usual tests for liver fibrosis. Those at high risk for liver fibrosis will be directed to receive a confirmatory blood draw at a local laboratory prior to treatment initiation. Participants will complete transient elastography after treatment initiation.

Group Type: EXPERIMENTAL

DBS TaT

Intervention Type: OTHER

Dried Blood Spot (DBS) testing for HCV DCHEQ and Baseline Surveys If at high risk for liver fibrosis, blood draw prior to treatment initiation If low risk for liver fibrosis, Telemedicine visit with PATHS provider HCV treatment initiation Transient elastography (TEG)

Usual Care

At usual care sites, participants either self-report a known history of untreated HCV or undergo peer-performed point-of-care HCV antibody testing or DBS for HCV testing. Peers take those with positive results to local laboratories for a confirmatory blood draw prior to treatment initiation, the results of which are received and managed by PATHS providers. When active HCV is diagnosed, PATHS staff coordinate on-demand telemedicine visits with peers and participants, during which PATHS clinicians recommend treatment. Participants will complete transient elastography after treatment initiation.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Point-of-care or DBS testing for HCV Blood draw to test liver fibrosis DCHEQ and Baseline Surveys Telemedicine visit with PATHS provider HCV treatment initiation Transient elastography (TEG)

Interventions

DBS TaT

Dried Blood Spot (DBS) testing for HCV DCHEQ and Baseline Surveys If at high risk for liver fibrosis, blood draw prior to treatment initiation If low risk for liver fibrosis, Telemedicine visit with PATHS provider HCV treatment initiation Transient elastography (TEG)

Intervention Type: OTHER

Usual Care

Point-of-care or DBS testing for HCV Blood draw to test liver fibrosis DCHEQ and Baseline Surveys Telemedicine visit with PATHS provider HCV treatment initiation Transient elastography (TEG)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Active hepatitis C infection
• Willing to engaged with the PATHS program for clinical care

Exclusion Criteria

• Currently pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Oregon Clinical and Translational Research Institute

OTHER

Sponsor Role: collaborator

Collins Medical Trust

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Hunter Spencer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hunter Spencer, DO

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hunter Spencer, DO

Role: CONTACT

spencerh@ohsu.edu

503-681-4233

Tonhi Gailey

Role: CONTACT

gailey@ohsu.edu

Facility Contacts

Tonhi Gailey

Role: primary

gailey@ohsu.edu

503 494 8311

Other Identifiers

KL2TR002370

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00026983

Identifier Type: -

Identifier Source: org_study_id