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The Kentucky Viral Hepatitis Treatment Study (KeY Treat)

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ClinicalTrials.gov Identifier: NCT03949764
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
Gilead Sciences
University of Kentucky
Icahn School of Medicine at Mount Sinai
University of Bristol
Information provided by (Responsible Party):
Jennifer Havens, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Opioid-Related Disorders Injection Drug Use Drug: Sofosbuvir/velpatasvir (Epclusa®)

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.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort Intervention/treatment
HCV Positive Study Participants
Study participants will be administered a standard 12-week course of sofosbuvir/velpatasvir (Epclusa®).
Drug: Sofosbuvir/velpatasvir (Epclusa®)
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.

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.



Primary Outcome Measures :
  1. 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.

  2. Treatment Completion [ Time Frame: Visit 6, 24 weeks post-baseline ]
    Defined as receiving all doses of medication, to be measured by number of pills left and viral load.

  3. Sustained Virologic Response (SVR) [ Time Frame: Visit 7, 50 weeks post-baseline ]
    Defined as undetectable viral RNA at the 12-week post-completion blood draw (SVR-12).

  4. Re-infection [ Time Frame: Visit 8, 102 weeks post-baseline ]
    Defined as the presence of viral RNA at either the 6- or 12-month follow-up after achieving SVR.


Secondary Outcome Measures :
  1. Prevalence of HCV [ Time Frame: Visit 8, 102 weeks post-baseline ]
    Prevalence of HCV in study population, measured by viral load.

  2. Incidence of HCV [ Time Frame: Visit 8, 102 weeks post-baseline ]
    Incidence of HCV in study population, measured by viral load and new cases.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for KeY Treat includes Perry County residents who are chronically/acutely infected with HCV. The potential sample size of approximately 900 RNA-positive residents was estimated using data from our NIDA-funded longitudinal cohort study of high-risk drug users (SNAP, 2008-2018), the Focus Opt-out Testing Project in the Appalachian Regional Hospital emergency room (ARH, ongoing) and a NIDA-funded study of incarcerated female drug users (WISH, 2012-2017). Approximately 792 RNA-positive residents are RNA-positive, and therefore eligible for study participation (see Eligibility Criteria below). We will likely identify an additional 100 participants in addition to the estimate below through the screening activities outlined in Eligibility Criteria.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949764


Contacts
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Contact: Jennifer Havens, PhD (859) 323-6553 jennifer.havens@uky.edu
Contact: Madelyn McDonald, MPH 8595622291 madelyn.mcdonald@uky.edu

Locations
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United States, Kentucky
ARH Medical Mall Not yet recruiting
Hazard, Kentucky, United States, 41701
Contact: Britteny Williams, MBA    606-439-0326      
Sponsors and Collaborators
Jennifer Havens
National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
Gilead Sciences
University of Kentucky
Icahn School of Medicine at Mount Sinai
University of Bristol
Investigators
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Principal Investigator: Jennifer Havens, PhD University of Kentucky Ctr on Drug & Alcohol Rsrch

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Responsible Party: Jennifer Havens, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03949764     History of Changes
Other Study ID Numbers: 47239
R01DA047952 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents