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

Hepatitis C, Chronic Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic

• NCT number: NCT03987503
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Completion date: December 29, 2022