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Comparison of OraQuick HCV Rapid Antibody Test and Standard Serologic Screening for Hepatitis C: Validity, Acceptability and Impact on Linkage to Care

NCT02084719 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-01-20

No results posted yet for this study

Summary

Rapid tests are increasingly used in medical practice, notably to screen for HIV. Their use has been associated with a faster linkage to care and lower rates of loss to follow up. Rapid tests are also well accepted by patients and clinicians.

No rapid test is currently approved in Canada for screening of hepatitis C. Hepatitis C diagnosis is done through based on blood testing and the screening algorithm may require up to 3 visits to clarify the hepatitis C status.

The Oraquick HCV test is a rapid test done on blood or saliva that can replace the first step of the regular screening algorithm. With this test the initial screening and the confirmation test can be done in one visit.

The primary endpoint of this pilot-project is to evaluate clinical characteristics of Oracquick HCV (sensitivity, specificity, positive and negative predictive values) and to compare them to those of the standard screening algorithm in a population of active or ex-users of injected drugs. The project also intend to evaluate if the rapid test can reduce the rates of loss to follow up and increase the linkage to hepatitis C specialized care. This last endpoint will be evaluated through phone call follow up 6 months after the screening.

One hundred and fifty patients will be included. Half will be tested with the standard algorithm and the Oraquick HCV test (group A) and half will be tested only with the standard algorithm.

Results of group A will be used to determine the clinical characteristics of Oraquick HCV. Results of groups A and B will be used to evaluate rates of loss to follow up, costs avoided by the use of the rapid test and linkage to care of infected patients.

Conditions

  • Active or Ex-injection Drug Users
  • Indication of Hepatitis C Screening

Interventions

DEVICE

Oraquick HCV Rapid Antibody Test

DEVICE

Standard algorithm

Sponsors & Collaborators

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Valérie Martel-Laferrière, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02084719 on ClinicalTrials.gov