Information:
Error:
ID
39889
Description
Rapid Diagnostics for HIV and Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT02190305
Link
https://clinicaltrials.gov/show/NCT02190305
Keywords
Versions (1)
- 2/29/20 2/29/20 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
February 29, 2020
DOI
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License
Creative Commons BY 4.0
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Eligibility HIV Infections NCT02190305
Eligibility HIV Infections NCT02190305
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Similar models
Eligibility HIV Infections NCT02190305
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Study Subject All
Item
all subjects:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,2])
Age
Item
13 years of age or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Parent | Informed Consent Guardian
Item
able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
Risk Assessment Questionnaire Completion
Item
willing to complete the risk assessment questionnaire, and
boolean
C0086930 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Availability of Blood specimen | Finger-prick sampling Drop Quantity | Serum Separator Tube Quantity | Anticoagulant Microcapillary blood collection tube K2EDTA Quantity
Item
willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (k2 edta) tubes.
boolean
C0470187 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0457575 (UMLS CUI [2,1])
C4048603 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1553430 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003280 (UMLS CUI [4,1])
C3872453 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0178913 (UMLS CUI [1,2])
C0457575 (UMLS CUI [2,1])
C4048603 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1553430 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003280 (UMLS CUI [4,1])
C3872453 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Population At risk Group
Item
population 1 - diagnostic trial "at risk" group (n = 2000-3000)
boolean
C1257890 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
Inclusion criteria Quantity Fulfill
Item
subjects must meet one or more of the following inclusion criteria to be enrolled in population 1:
boolean
C1512693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Risk factors Quantity Hepatitis B | Risk factors Quantity Hepatitis C
Item
have at least one risk factor for infection with hepatitis b or c,
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
C1265611 (UMLS CUI [1,2])
C0019163 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Risk factors Quantity HIV Infection
Item
have at least one risk factor for infection with hiv,
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
Signs and Symptoms Hepatitis
Item
present with signs and symptoms of hepatitis,
boolean
C0037088 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
C0019158 (UMLS CUI [1,2])
HIV Seropositivity | HIV test Positive
Item
be a known hiv-positive individual (previous positive hiv test result, may comprise up to 500 individuals)
boolean
C0019699 (UMLS CUI [1])
C1321876 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1321876 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Population Group HIV Seropositivity
Item
population 1a - additional known hiv-positive individuals (n = ~500)
boolean
C1257890 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
C0019699 (UMLS CUI [1,2])
Study Subject Criteria Fulfill
Item
subjects must:
boolean
C0681850 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
HIV Seropositivity | HIV test Positive
Item
• be a known hiv-positive individual (previous positive hiv test result).
boolean
C0019699 (UMLS CUI [1])
C1321876 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1321876 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Population Group Hepatitis B Virus Positive
Item
population 1b - additional known hbv-positive individuals (n = ~500)
boolean
C1257890 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0019169 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Study Subject Criteria Fulfill
Item
subjects must:
boolean
C0681850 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hepatitis B | Serology positive Hepatitis B Virus
Item
• be known to have current or past hbv infection, as evidenced by hbv serology results.
boolean
C0019163 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
C0242089 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
Population Group Hepatitis C Virus Positive
Item
population 1c - additional known hcv-positive individuals (n = ~500)
boolean
C1257890 (UMLS CUI [1,1])
C4330254 (UMLS CUI [1,2])
C4330254 (UMLS CUI [1,2])
Study Subject Criteria Fulfill
Item
subjects must:
boolean
C0681850 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hepatitis C | Hepatitis C virus test Positive
Item
• be known to be infected with hcv, as evidenced by previous positive hcv test results.
boolean
C0019196 (UMLS CUI [1])
C2363789 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C2363789 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Study Subject Inclusion criteria failed
Item
subjects do not meet the inclusion criteria
boolean
C0681850 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])