The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

PHASE4CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

October 30, 2022

Study Completion Date

December 29, 2022

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Epclusa (SOF/VEL)

a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.

DRUG

Standard of care

Standard of HCV care provided by medical care provider

DEVICE

Fibroscan® 430 Mini Plus

"Trained research staff will measure participants liver stiffness using liver ultrasonographic elastography. Research staff place ultrasound gel directly on participant's skin on the area of the torso. Research staff will position the participant's body on the exam table to assure the liver can be located, placing the small probe on the body's surface (skin with gel) and begin recording images of the participant's liver.~The procedure will take 15-30 minutes, depending on the ease with which the research staff is able to accurately locate the participant's liver.~Results from the FibroScan will be discussed with a trained provider."

Trial Locations (1)

94153

University of California, San Francisco, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

University of California, San Francisco

OTHER

NCT03987503 - The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study | Biotech Hunter | Biotech Hunter