The Kentucky Viral Hepatitis Treatment Study

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase hepatitis C virus (HCV) treatment access and delivery in a rural Appalachian community, which is in the midst of the opioid/hepatitis C (HCV) syndemic. KeY Treat is a clinical research study seeking to determine whether removing barriers (cost, insurance, specialist, abstinence) associated with accessing direct-acting antivirals (DAAs) for the treatment of HCV will impact health in Perry County, Kentucky.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Havens
• Collaborators: Gilead Sciences; Icahn School of Medicine at Mount Sinai; National Cancer Institute (NCI); National Institute on Drug Abuse (NIDA); University of Bristol; University of Kentucky
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Inclusion Criteria:

• RNA positive for HCV

• Perry County residency (verified via ID card showing local address, lease, utility bill, etc.)

• 18 years of age or older

Exclusion Criteria:

• Individuals who are unable to provide consent (to be determined by local study staff in conjunction with our psychiatrist, Dr. Lofwall, a Co-I on the study)

• Individuals under 18 years of age (study drugs not FDA-approved for those <18)

• Pregnant women (unable to participate during duration of pregnancy, but encouraged to return following delivery)