- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378118
Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old
Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old
Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva as an alternative specimen for HIV testing has been explored. Today, very sensitive tests have been formulated and have been used for diagnosing HIV in adults and older children. OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as well test the saliva.
Most studies done on the use of saliva have been carried out in adults and have produced very good results. However very few such studies have been done in children, especially infants. In adults, use of saliva has also highlighted the advantages of ease of collection and increased acceptability of testing.
HYPOTHESIS OraQuick rapid test can detect antiHIV antibodies as well as the Abbott determine test and oral fluid testing is more acceptable than blood testing.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND Serological identification of antibodies to Human Immunodeficiency virus (HIV) in blood is the most widely used method to screen for HIV infection. Use of oral fluid as an alternative to blood sample has been studies the past 20 years and extremely sensitive tests that are able to detect the very low quantities of antibodies found in oral fluid have been formulated and are currently being used. OraQuick rapid test, a combination, collection and testing device that uses both blood and oral fluid was approved for used by the U.S.A, FDA in 2002 and has been tested in adults and older children.
The value of oral fluid in screening for HIV infection in adults is now well established and has been used extensively in field survey and epidemiologic studies. However, these methods have not been studied in children in whom differences in test performance might be expected. Studies in adults have also highlighted the advantages of oral fluid testing, such as ease of collection and high degree of acceptability of testing. This would make oral fluid testing a good alternative for HIV screening in infants, a challenging population in which venipuncture is often difficult or unacceptable.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Lusaka, Zambia, P/B RW 1
- University Teaching Hospital,Department of Pediatrics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged less than 18 months
- Admission to the Department of Pediatrics for any condition
- Consent from caregiver for HIV testing using both oral fluid and blood r
Exclusion Criteria:
- Age of more than 18 months
- Refusal of consent by caregiver
- Outpatients
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity and specificity of the OraQuick rapid test
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Acceptance of HIV testing using oral fluid
Time Frame: one year
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one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine M Chunda, Medicine, University of Zambia/University Teaching Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ThrasherRF
- IRB00001131 of IORG0000774
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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