Clinical trial NCT03949764: The Kentucky Viral Hepatitis Treatment Study
Official title: Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hepatitis C
Opioid-Related Disorders
Injection Drug Use
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Cancer Institute (NCI)
name: Gilead Sciences
name: University of Kentucky
name: Icahn School of Medicine at Mount Sinai
name: University of Bristol
First posted: 2019-05-14
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Treatment Uptake
timeFrame: Visits 1-5, 1 to 12 weeks post-baseline
measure: Treatment Completion
timeFrame: Visit 6, 24 weeks post-baseline
measure: Sustained Virologic Response (SVR)
timeFrame: Visit 7, 50 weeks post-baseline
measure: Re-infection
timeFrame: Visit 8, 102 weeks post-baseline
Secondary outcomes:
measure: Prevalence of HCV
timeFrame: Visit 8, 102 weeks post-baseline
measure: Incidence of HCV
timeFrame: Visit 8, 102 weeks post-baseline
Other outcomes:
Locations:
city: Hazard
country: United States
facility: ARH Medical Mall
state: Kentucky
Study officials:
affiliation: University of Kentucky Ctr on Drug & Alcohol Rsrch
name: Jennifer Havens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Havens JR, Schaninger T, Fraser H, Lofwall M, Staton M, Young AM, Hoven A, Walsh SL, Vickerman P. Eliminating hepatitis C in a rural Appalachian county: protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C. BMJ Open. 2021 Jul 5;11(7):e041490. doi: 10.1136/bmjopen-2020-041490.