The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with
      chronic HCV infection. For marginalized communities, linkage to care services often aren't
      enough to overcome barriers to accessing the medical system. For difficult to link
      populations, offering treatment at the same non-clinical community space may improve uptake
      and reduce loss-to-follow-up. The purpose of this 2 year study is to assess the feasibility,
      acceptability and effectiveness of accelerated initiation of commercially available DAA
      therapy targeting socially marginalized communities (e.g., medically underserved, homeless,
      people actively injecting drugs). The study will be carried out at two community sites that
      perform HCV testing: (a) fixed community site and (b) community mobile site via clinical
      research van. Participants (n=150) who test anti-HCV positive and HCV RNA positive (chronic
      infection) are invited to enroll into the no one waits (NOW) Study and begin HCV treatment at
      point of diagnosis. All evaluation, medication dissemination, and follow-up care will take
      place at the project site. The investigators will estimate the effect of on-site
      point-of-diagnosis (POD) treatment on (1) time from HCV testing to treatment initiation, (2)
      completing treatment, and (3) attaining (sustained virologic response) SVR-12; overall and by
      study site. A secondary product will be a lesson learned guide of recommendations for
      implementing a POD on-site test and treat program for dissemination beyond San Francisco.
    

Detailed description: 
      This study is a non-randomized interventional study.

      NOW is an open-label study evaluating the feasibility, acceptability, and effectiveness of an
      accelerated community-based treatment program of SOF/VEL x 12 weeks started at time of
      chronic HCV diagnosis (intervention).

      The purpose of the proposed study is to assess the feasibility, acceptability and
      effectiveness of accelerated initiation of commercially available direct-acting antiviral
      (DAA) therapy targeting socially marginalized communities (e.g., medically underserved,
      homeless, people actively injecting drugs). The proposed study will be carried out at two
      community sites that perform HCV testing: (a) fixed community site and (b) community mobile
      site. The fixed site is located in the Tenderloin Neighborhood of San Francisco: The Quaker
      Meeting House (QMH). The QMH is the current location for an established drop-in center for
      young adult (< 30 years old) people who inject drugs, a group at highest risk for acquiring
      new HCV infection but representing a group with the lowest engagement in HCV treatment. The
      QMH site is complete with two phlebotomy stations, centrifuge, clinical exam station,
      interview rooms, and office space. The QMH research site will prioritize study enrollment for
      young adult people who inject drugs (PWID). The community mobile site (DeLIVER Van) is
      situated in a mobile van; a 145 sqft space equipped with a phlebotomy station, clinical exam
      table, centrifuge, and portable Fibroscan® 430 Mini Plus. The DeLIVER Van will serve two
      neighborhoods in San Francisco with high HCV burden but few community-based medical service
      organizations: the Bayview neighborhood and Outer Mission neighborhood.

      The investigators will (1) implement new tools, notably FIBROSCANS, to measure fibrosis in an
      at-risk group (HCV positive patients); (2) implement a new standard of care, treatment
      on-demand in an at-risk group (HCV positive active drug users); (3) assess the feasibility
      and acceptability of expanding standard of care into non-clinical settings.

      At study entry, participants will undergo a combined eligibility screening/entry visit, which
      includes HCV testing (antibody and RNA), rapid anti-HIV test, and HBsAG (hepatitis B virus
      surface antigen) testing and consent for medical record linkage. If HCV RNA reactive,
      participants are offered enrollment into the treatment cohort and provided 2 week supply of
      SOF/VEL (provided by Gilead as part of the NOW Study) upon completion of a clinical
      evaluation, baseline survey, and venipuncture for baseline labs. If the participant is
      actively insured, the study investigators will obtain insurance-authorized SOF/VEL to
      complete the remainder of the 12 week treatment course. If the participant is not actively
      insured, the study team will assist with insurance acquisition and subsequently obtain
      insurance-authorized SOF/VEL to complete the remainder of the 12 week treatment course. For
      any participants, if insurance-authorized SOF/VEL is delayed beyond the initial 2 week
      study-provided SOF/VEL, additional supplies of SOF/VEL as needed to ensure an uninterrupted
      12 week treatment course. Participants will return every 2 weeks during treatment (12 week
      course) for medication dispensation and study visit activities. And for two post-treatment
      visits for clinical monitoring (e.g., HCV RNA testing) and research activities.

      Study participants in the intervention study (cohort): Chronic HCV (anti-HCV positive and HCV
      RNA positive) men and women ages ≥18 years newly diagnosed or re-engaged in care at a fixed
      or mobile community-based site. Participants should be HBsAg negative, have no known history
      of decompensated cirrhosis or end stage renal disease, not be pregnant or breastfeeding, and
      not be taking medications that are contraindicated with SOF/VEL.
    

Intervention name(s): Epclusa (SOF/VEL); Standard of care; Fibroscan® 430 Mini Plus
Intervention type(s): Drug; Drug; Device
Intervention description(s): 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.; Standard of HCV care provided by medical care provider; 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.
Other intervention name(s): Fibroscan
Intervention MeSH terms: Sofosbuvir-velpatasvir drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: People who inject drugs; Homeless; Community-based testing and treatment