- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949764
The Kentucky Viral Hepatitis Treatment Study (KeY Treat)
July 14, 2023 updated by: Jennifer Havens
Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase access to treatment for the hepatitis C virus (HCV) in a rural Appalachian community in the midst of the opioid/HCV syndemic.
This study seeks to examine whether removing barriers associated with accessing direct-acting antivirals (DAAs) for the treatment of HCV (high out-of-pocket costs, insurance restrictions requiring a specialist, abstinence, and significant liver damage) will significantly reduce the burden of HCV in Perry County, Kentucky.
The proposed study is made possible by a significant drug donation from Gilead Sciences for sofosbuvir/velpatasvir, a 12-week, once per day, pan-genotypic DAA.
KeY Treat proposes a multi-pronged approach to treating HCV using a mid-level provider model.
In addition to DAA treatment, participants will be offered access to subsidized medication-assisted treatment, syringe services, and case management.
Existing resources in the target community (public health, jail, hospital) will be leveraged, as well as ongoing projects dedicated to increasing access to HCV care in affected communities (ECHO, FOCUS) to answer whether removing the major barriers to HCV treatment affect access, and what barriers remain.
All RNA-positive residents of Perry County, Kentucky will be eligible/recruited for study participation (N≈900), and the following specific aims will be addressed: 1) determination of HCV treatment uptake among rural residents with chronic HCV; 2) examination of the predictors of treatment completion among those enrolled in KeY Treat; 3) examination of the characteristics of participants achieving sustained virologic response (SVR, or cure); 4) establishment of long-term re-infection rates among those achieving SVR; 5) examination of 5-year reductions in incidence and prevalence of HCV in the intervention community compared with a control county in rural Kentucky; and 6) evaluate the impact and cost-effectiveness of KeY Treat using mathematical modeling.
The proposed research has tremendous potential to impact public health in the rural United States.
The majority of counties identified in CDC's recent HCV/HIV hotspot analysis were rural, and there is a real need to improve access to DAAs in order to prevent further HCV transmission, reduce the burden of advanced liver disease, and hepatocellular carcinoma in generations to come.
Data from KeY Treat will inform policies around Medicaid/insurance restrictions for DAAs, and will deliver a much needed blueprint for the provision of HCV treatment in resource-deprived rural areas.
Study Type
Interventional
Enrollment (Actual)
374
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Havens, PhD
- Phone Number: (859) 323-6553
- Email: jennifer.havens@uky.edu
Study Contact Backup
- Name: Madelyn McDonald, MPH
- Phone Number: 8595622291
- Email: madelyn.mcdonald@uky.edu
Study Locations
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Kentucky
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Hazard, Kentucky, United States, 41701
- ARH Medical Mall
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HCV Positive Study Participants
Study participants will be administered a standard 12-week course of sofosbuvir/velpatasvir (Epclusa®).
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The protocol is intended to follow best practices/standard of care for the treatment of HCV, with additional allowances for the investigators to apply rigorous scientific practices for the research aspects of the study.
While the treatment of HCV is fairly straightforward, less is known about treating active drug users and RNA-positive individuals in rural areas.
We propose eight visits, including intake, four treatment-related visits, and three visits to determine re-infection (6- and 12-months post-SVR).
Because determination of medication adherence and long-term reinfection rates are not part of standard clinical practice, the rural protocol developed at the conclusion of KeY Treat will be streamlined based on findings, consisting of five or fewer clinical contacts.
The drug used for treatment is Epclusa®, a 12-week, once per day, pan-genotypic DAA with a favorable side effect profile.
Vosevi® will also be available in cases where participants are non-responsive or are re-infected.
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No Intervention: Control (Pike County)
After completion of the study, we will compare HCV incidence and prevalence rates in Perry County (intervention) and Pike County (control).
This will be measured through data provided by the local health departments of each county.
Confidential Hepatitis C screening will be conducted in some cases, and resources will be provided to those testing positive but they will not receive treatment as part of this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Uptake
Time Frame: Visits 1-5, 1 to 12 weeks post-baseline
|
Defined as receiving the first dose of medication, to be measured by number of pills left and viral load.
|
Visits 1-5, 1 to 12 weeks post-baseline
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Treatment Completion
Time Frame: Visit 6, 24 weeks post-baseline
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Defined as receiving all doses of medication, to be measured by number of pills left and viral load.
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Visit 6, 24 weeks post-baseline
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Sustained Virologic Response (SVR)
Time Frame: Visit 7, 50 weeks post-baseline
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Defined as undetectable viral RNA at the 12-week post-completion blood draw (SVR-12).
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Visit 7, 50 weeks post-baseline
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Re-infection
Time Frame: Visit 8, 102 weeks post-baseline
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Defined as the presence of viral RNA at either the 6- or 12-month follow-up after achieving SVR.
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Visit 8, 102 weeks post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of HCV
Time Frame: Visit 8, 102 weeks post-baseline
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Prevalence of HCV in study population, measured by viral load.
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Visit 8, 102 weeks post-baseline
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Incidence of HCV
Time Frame: Visit 8, 102 weeks post-baseline
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Incidence of HCV in study population, measured by viral load and new cases.
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Visit 8, 102 weeks post-baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Havens, PhD, University of Kentucky Ctr on Drug & Alcohol Rsrch
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2019
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
May 13, 2019
First Posted (Actual)
May 14, 2019
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Narcotic-Related Disorders
- Hepatitis
- Hepatitis A
- Hepatitis C
- Opioid-Related Disorders
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Sofosbuvir-velpatasvir drug combination
- Velpatasvir
Other Study ID Numbers
- 47239
- R01DA047952 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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