CompletedPhase 4

The Kentucky Viral Hepatitis Treatment Study

United States374 participantsStarted 2019-09-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Treatment Uptake

Timeframe: Visits 1-5, 1 to 12 weeks post-baseline

Treatment Completion

Timeframe: Visit 6, 24 weeks post-baseline

Sustained Virologic Response (SVR)

Timeframe: Visit 7, 50 weeks post-baseline

Re-infection

Timeframe: Visit 8, 102 weeks post-baseline

Trial details

NCT IDNCT03949764

SponsorJennifer Havens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

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