The Kentucky Viral Hepatitis Treatment Study (KeY Treat)
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|ClinicalTrials.gov Identifier: NCT03949764|
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Opioid-Related Disorders Injection Drug Use||Drug: Sofosbuvir/velpatasvir (Epclusa®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Increasing Access to Hepatitis C Treatment in Opioid Endemic Rural Areas: The Kentucky Viral Hepatitis Treatment (KeY Treat) Study|
|Actual Study Start Date :||September 23, 2019|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: 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.
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.
- 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.
- 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.
- 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).
- 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.
- Prevalence of HCV [ Time Frame: Visit 8, 102 weeks post-baseline ]Prevalence of HCV in study population, measured by viral load.
- Incidence of HCV [ Time Frame: Visit 8, 102 weeks post-baseline ]Incidence of HCV in study population, measured by viral load and new cases.
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
|Contact: Jennifer Havens, PhD||(859) email@example.com|
|Contact: Madelyn McDonald, MPHfirstname.lastname@example.org|
|United States, Kentucky|
|ARH Medical Mall||Recruiting|
|Hazard, Kentucky, United States, 41701|
|Contact: Britteny Williams, MBA 606-439-0326|
|Principal Investigator:||Jennifer Havens, PhD||University of Kentucky Ctr on Drug & Alcohol Rsrch|