DBS TaT in Peer-assisted Telemedicine for Hepatitis C

NCT06409169 | Recruiting DMC

• 2 other identifiers: STUDY00026983KL2TR002370
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatitis C

Keywords

Hepatitis C; Substance Use

Outcome Measures

Primary Outcomes (1)

• HCV Treatment Initiation

  Rate of hepatitis C (HCV) treatment initiation in sites utilizing DBS TaT versus sites utilizing usual care.

  12 weeks after diagnosis of HCV

Secondary Outcomes (2)

• HCV Cure

  24 weeks after treatment completion

• Time from HCV Diagnosis to Treatment Initiation

  12 weeks

Study Arms (2)

DBS TaT

EXPERIMENTAL

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.

Other: DBS TaT

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

DBS TaT 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)

DBS TaT

Usual Care 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)

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Currently pregnant

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Oregon Clinical and Translational Research Institute: collaborator
• Collins Medical Trust: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hunter Spencer, DO

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hunter Spencer, DO

CONTACT

503-681-4233; spencerh@ohsu.edu

Tonhi Gailey

CONTACT

gailey@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: January 22, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)