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Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Thrasher Research Fund
ClinicalTrials.gov Identifier:
NCT00378118
First received: September 18, 2006
Last updated: November 5, 2007
Last verified: November 2007

September 18, 2006
November 5, 2007
December 2006
Not Provided
Sensitivity and specificity of the OraQuick rapid test [ Time Frame: one year ]
Not Provided
Complete list of historical versions of study NCT00378118 on ClinicalTrials.gov Archive Site
Acceptance of HIV testing using oral fluid [ Time Frame: one year ]
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Children admitted to the University Teaching Hospital,Lusaka,Zambia with various illnesses and aged less than 18 months old

HIV Antibody Testing
  • 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
Not Provided
Tess BH, Granato C, Parry JV, Santos VA, Lago TG, Newell ML, Dunn DT, Rodrigues LC. Salivary testing for human immunodeficiency virus type 1 infection in children born to infected mothers in Sao Paulo, Brazil. The Sao Paulo Collaborative Study for Vertical Transmission of HIV-1. Pediatr Infect Dis J. 1996 Sep;15(9):787-90.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
September 2007
Not Provided

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
Both
up to 18 Months
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT00378118
ThrasherRF, IRB00001131 of IORG0000774
Yes
Not Provided
Thrasher Research Fund
Centers for Disease Control and Prevention
Principal Investigator: Catherine M Chunda, Medicine University of Zambia/University Teaching Hospital
Thrasher Research Fund
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP