The Kentucky Viral Hepatitis Treatment Study (NCT03949764) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Uptake
Timeframe: Visits 1-5, 1 to 12 weeks post-baseline