Preliminary Evaluation of a Point-Of-Care Liver Function Test
DFA
Preliminary Field Evaluation of a Point-of-Care Transaminase Test
1 other identifier
interventional
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Jun 2012
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 31, 2013
January 1, 2013
2 months
August 21, 2012
January 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
at time of draw
Study Arms (1)
Diagnostics for All liver function test (LFT)
EXPERIMENTALHIV 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)
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PATHlead
Study Sites (1)
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nira Pollock, MD,PhD
Harvard University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2012
First Posted
October 12, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
January 31, 2013
Record last verified: 2013-01