DBS TaT in Peer-assisted Telemedicine for Hepatitis C

Hepatitis C Clinical Trial

Official title:

Dried Blood Spot Testing in Peer-assisted Telemedicine for Hepatitis C Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409169
• Other study ID #: STUDY00026983
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Oregon Health and Science University
• Contact: Hunter Spencer, DO
• Phone: 503-681-4233
• Email: spencerh[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 183
• Est. completion date: May 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active hepatitis C infection

• Willing to engaged with the PATHS program for clinical care

Exclusion Criteria:

• Previous treatment with direct acting antivirals for hepatitis C

• Chronic hepatitis B virus (HBV) infection

• HIV infection

• Currently pregnant

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Other:
• 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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV Treatment Initiation	Rate of hepatitis C (HCV) treatment initiation in sites utilizing DBS TaT versus sites utilizing usual care tested within 24 weeks of treatment initiation.	12 weeks after diagnosis of HCV
Secondary	HCV Cure	Rate of hepatitis C (HCV) cure in sites utilizing DBS TaT versus sites utilizing usual care tested within 24 weeks of treatment initiation.	24 weeks after treatment completion
Secondary	Time from HCV Diagnosis to Treatment Initiation	Time from diagnosis of HCV to HCV treatment initiation	12 weeks