Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-07
Brief Title:
DBS TaT in Peer-assisted Telemedicine for Hepatitis C
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Dried Blood Spot Testing in Peer-assisted Telemedicine for Hepatitis C Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None