NCT04302948

Rapid HCV RNA Testing and LInkage to Care

University of New Mexico·ClinicalTrials.gov·other
View on ClinicalTrials.gov
Study focus
Disease/Condition
Hepatitis C, Chronic
Drug/Device/Intervention
HCV RNA screening
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University of New Mexico
Location
Albuquerque,Albuquerque, United States of America
Timeline & enrollment
Phase
N/A
Start date
Mar 02, 2020
End date
Dec 01, 2020
Enrollment
210 participants
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
Chronic viral hepatitis CAcute hepatitis CChronic hepatitis, unspecifiedChronic viral hepatitisChronic viral hepatitis, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04302948
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04302948 through Pure Global AI's free database. This phase not specified trial is sponsored by University of New Mexico and is currently status unknown. The study focuses on Hepatitis C, Chronic. Target enrollment is 210 participants.

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