Preliminary Evaluation of a Point-Of-Care Liver Function Test (DFA)
Primary Purpose
HIV, Tuberculosis, Drug-Induced Liver Injury
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Diagnostics for All liver function test (LFT)
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV
Eligibility Criteria
Inclusion Criteria:
- Adult (>18 years old) patients receiving HIV treatment through the HTD clinic
- Must be receiving routine scheduled ALT monitoring on day of enrollment
- Willing to undergo finger-stick in addition to routine care
- Must be able to provide informed consent.
Exclusion Criteria:
- HIV-negative, or HIV-positive but not on treatment
- Not receiving transaminase monitoring for routine care
- Unable or unwilling to provide informed consent
- Less than 18 years old
Sites / Locations
- Hospital for Tropical Diseases
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostics for All liver function test (LFT)
Arm Description
HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
Outcomes
Primary Outcome Measures
percent agreement with gold standard test
Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01705041
Brief Title
Preliminary Evaluation of a Point-Of-Care Liver Function Test
Acronym
DFA
Official Title
Preliminary Field Evaluation of a Point-of-Care Transaminase Test
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PATH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase test with the standard of care test used in an HIV clinic at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.
Detailed Description
The DFA transaminase test provides rapid categorical measurement of ALT in a whole blood specimen taken via finger-stick. The test is based on the platform technology of "paper microfluidics" (also known as "patterned paper"), in which hydrophobic barriers are patterned into a sheet of paper in order to create microfluidic, hydrophilic paths within the paper, through which flow can be directed towards specific detection zones. The test is designed for visual color-coded readout in three ALT ranges ("bins") that correspond to the ranges of AST and ALT (<3x the upper limit of normal (ULN), 3-5x ULN, and >5x ULN) currently used for clinical management decisions per US TB and HIV treatment guidelines. The bin cutoffs are common to treatment guidelines used around the globe, including those used by the Vietnam Ministry of Health.
The colorimetric readout is designed to be read by eye using a visual "read guide" allowing the reader to make a semi-quantitative estimate or assign a categorical value into one of three bins. Alternatively, if the device is scanned (e.g. desk-top scanner) or photographed (e.g. cell phone or standard digital camera, see (9)) and read with image-analysis software, it should be possible to generate a quantitative result. Additionally, multiple control zones notify the user of insufficient sample volume, hemolysis, or damaged reagents.
The overall goal of this study is to conduct a preliminary field evaluation of an investigational transaminase test in a population at risk for DILI. The primary objectives are:
Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.
Determine inter-operator variability.
Determine device failure rate as defined by invalid test results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Tuberculosis, Drug-Induced Liver Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostics for All liver function test (LFT)
Arm Type
Experimental
Arm Description
HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
Intervention Type
Device
Intervention Name(s)
Diagnostics for All liver function test (LFT)
Other Intervention Name(s)
Diagnostics for All (DFA) liver function test (LFT), ALT, transaminase
Intervention Description
HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
Primary Outcome Measure Information:
Title
percent agreement with gold standard test
Description
Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.
Time Frame
at time of draw
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (>18 years old) patients receiving HIV treatment through the HTD clinic
Must be receiving routine scheduled ALT monitoring on day of enrollment
Willing to undergo finger-stick in addition to routine care
Must be able to provide informed consent.
Exclusion Criteria:
HIV-negative, or HIV-positive but not on treatment
Not receiving transaminase monitoring for routine care
Unable or unwilling to provide informed consent
Less than 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nira Pollock, MD,PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Tropical Diseases
City
Ho Chi minh City
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Preliminary Evaluation of a Point-Of-Care Liver Function Test
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