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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 - ongoing
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anecdotal study results reported in a talk today on NYS webinar on Drug Users & HCV is the Xpert test aligns with other old methods of testing. The wait was reported to be 45 minutes for Xpert results so patients could wait for results & potentially HCV treatment could be provided that day. Many doctors feel this is a game changer.
KeY Treat is one of the first microelimination trials in the USA and is uniquely targeting high-risk rural PWUD/PWID and former PWUD for HCV treatment. Results from this study will inform treatment efforts in rural regions adversely affected by the opioid/HCV/methamphetamine syndemic as well as the 2030 HCV elimination goals set forth by the WHO.
The Xpert HCV Viral Load Fingerstick (Cepheid) assay is used to determine study eligibility.
Phase I of in-person screening involves consenting to the screening, rapid antibody testing for HCV and HIV, and a pregnancy test for women of childbearing age. If HCV antibody-positive, an additional fingerstick is conducted at the same visit to collect a small blood specimen for rapid RNA testing (Xpert HCV Viral Load Fingerstick assay; Cepheid).
During the screening visit, anti-HCV and anti-HIV tests are conducted using the OraQuick HCV Rapid Antibody Test and OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (OraSure, Bethlehem, PA, USA). In-house rapid RNA testing is conducted using the GeneXpert HCV VL test (Cepheid). Participants undergo VL testing at the initial visit and all subsequent visits. Urine pregnancy screening is conducted among women of childbearing age at every visit.
Additional services
All participants meet with the study social worker at the initial visit, if they are non-adherent to the study medications, or if the participants request a meeting. The social worker continuously compiles a list of resources and potential referral mechanisms. In addition, the social worker will aid in securing identification, post office boxes (for services requiring a physical address) and, if necessary, medical insurance. KeY Treat has contracted with a local opioid treatment programme to provide subsidised OUD treatment (buprenorphine or methadone) for any participant who is interested. The study will pay for medication treatment of OUD while actively enrolled in KeY Treat, regardless of insurance status (~18 months). KeY Treat also provides funding to the local SSP so that clean syringes and other works are available to those enrolled in the study. Hepatitis A and B vaccinations are offered free of charge to all participants without laboratory-demonstrated immunity.
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