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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Active hepatitis C infection

• Willing to engaged with the PATHS program for clinical care

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Contact Information
Primary
Hunter Spencer, DO
spencerh@ohsu.edu
503-681-4233
Backup
Tonhi Gailey
gailey@ohsu.edu
Time Frame
Start Date: 2025-01-22
Estimated Completion Date: 2026-05
Participants
Target number of participants: 141
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Oregon Clinical and Translational Research Institute, National Center for Advancing Translational Sciences (NCATS), Collins Medical Trust
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov