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| Sponsors and Collaborators: |
Thrasher Research Fund Centers for Disease Control and Prevention |
|---|---|
| Information provided by: | Thrasher Research Fund |
| ClinicalTrials.gov Identifier: | NCT00378118 |
Purpose
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 | Intervention |
|---|---|
|
HIV Antibody Testing |
Other: Abbott-rapid HIV antibody test Other: OraQuick Rapid HIV-1/2 Antibody test |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old |
| Enrollment: | 1000 |
| Study Start Date: | December 2006 |
| Study Completion Date: | September 2007 |
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.
Eligibility| Ages Eligible for Study: | up to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children admitted to the University Teaching Hospital,Lusaka,Zambia with various illnesses and aged less than 18 months old
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Zambia | |
| University Teaching Hospital,Department of Pediatrics | |
| Lusaka, Zambia, P/B RW 1 | |
| Principal Investigator: | Catherine M Chunda, Medicine | University of Zambia/University Teaching Hospital |
More Information
| Study ID Numbers: | ThrasherRF, IRB00001131 of IORG0000774 |
| Study First Received: | September 18, 2006 |
| Last Updated: | November 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00378118 History of Changes |
| Health Authority: | Zambia: Research Ethics Committee |
|
HIV-1 HIV-2 |
|
Antibodies Immunologic Factors HIV Antibodies |
HIV Infections Acquired Immunodeficiency Syndrome Immunoglobulins |
|
Antibodies Immunologic Factors HIV Antibodies |
Physiological Effects of Drugs Pharmacologic Actions Immunoglobulins |
