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

Timeline & Enrollment

Primary Outcome

SVR-12,SVR-12, by project site

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.

ICD-10 Classifications