NCT03706742

STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12,386 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 53 Years – 74 Years
• Healthy volunteers: Accepted

Summary

Aim 1: The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among baby-boomers (i.e. persons born between 1945-1965): inreach with electronic medical record alerts and provider education vs. combination of inreach and provider education plus mailed outreach and patient navigation. Aim 2: The investigators will evaluate patient navigation strategies to promote follow-up testing and treatment evaluation among non-baby boomer Parkland patients (i.e. born before 1945 or after 1965) who are either: a) HCV antibody positive but have not completed follow-up viral load testing or b) HCV viral load positive and who have not completed in-clinic treatment evaluation.

Conditions

• Hepatitis C
• HepatoCellular Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Mailed outreach	The investigators will randomize all baby boomer patients (\~12,000 patients) using a centrally maintained computer-generated list. Patients will be randomly assigned to one of two HCV screening strategies including: visit-based screening as part of usual care (Group 1) or mailed screening invitation outreach and centralized patient navigation (Group 2).

Timeline

• Start date: 2018-09-10
• Primary completion: 2019-08-18
• Completion: 2021-03-31
• First posted: 2018-10-16
• Last updated: 2021-04-20

Locations

1 site across 1 country: United States