Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old
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|ClinicalTrials.gov Identifier: NCT00378118|
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : November 6, 2007
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.
|Condition or disease||Intervention/treatment|
|HIV Antibody Testing||Other: Abbott-rapid HIV antibody test Other: OraQuick Rapid HIV-1/2 Antibody test|
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 :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old|
|Study Start Date :||December 2006|
|Actual Study Completion Date :||September 2007|
- Other: Abbott-rapid HIV antibody test
Abbott will be used to test serum or whole blood
- Other: OraQuick Rapid HIV-1/2 Antibody test
OraQuick for oral fluid HIV antibody testing
- Sensitivity and specificity of the OraQuick rapid test [ Time Frame: one year ]
- Acceptance of HIV testing using oral fluid [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378118
|University Teaching Hospital,Department of Pediatrics|
|Lusaka, Zambia, P/B RW 1|
|Principal Investigator:||Catherine M Chunda, Medicine||University of Zambia/University Teaching Hospital|