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.