Rapid HCV RNA Testing and LInkage to Care - Trial NCT04302948

Timeline & Enrollment

Primary Outcome

Percentage of participants in each study arm who are evaluated by a provider specifically for HCV infection after screening

Summary

The investigators propose to conduct a pilot randomized controlled trial comparing treatment
 as usual (TaU) for HCV screening (rapid anti-HCV screening and referral) to a intervention
 screening that includes TaU plus a rapid point-of-care HCV RNA test in persons experiencing
 homelessness. The primary outcome of interest is linkage-to-care. Linkage to care is defined
 as evaluation by a health care provider for HCV infection within 30 days of baseline
 screening and referral. We will compare the proportion of patients who are evaluated by a
 provider within the 30 day window in each study arm: (1) participants who screened positive
 with rapid anti-HCV and are referred for evaluation) and (2) Rapid HCV RNA plus TaU (those
 who tested positive with both rapid anti-HCV and confirmatory RNA and are also referred to a
 provider.) Secondarily, the investigators will also assess HCV RNA levels in both groups
 twelve weeks after treatment ends (24 to 36 weeks after anti-HCV screening) to determine the
 percent of individuals who achieved sustained virologic response (SVR12), which is a marker
 for cure.

ICD-10 Classifications