Clinical Trial

Rapid HCV RNA Testing and LInkage to Care

Study Description

Rapid HCV RNA Testing and LInkage to Care

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

HCV RNA screening

The Cepheid Xpert testing requires a fingerstick to obtain blood spots which are then tested for HCV RNA. Results available within one to two hours, facilitating counseling for patients to link to care.

Additional Information

Official Study Title

Rapid HCV RNA Testing and LInkage to Care

Clinical Trial ID

NCT04302948

ParticipAid ID

aM80Pe