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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
Centers for Disease Control and Prevention
Information provided by:
Thrasher Research Fund

Brief Summary:

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

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 : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old
Study Start Date : December 2006
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Sensitivity and specificity of the OraQuick rapid test [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Acceptance of HIV testing using oral fluid [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children admitted to the University Teaching Hospital,Lusaka,Zambia with various illnesses and aged less than 18 months old

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Thrasher Research Fund
Centers for Disease Control and Prevention
Principal Investigator: Catherine M Chunda, Medicine University of Zambia/University Teaching Hospital

Additional Information:
ClinicalTrials.gov Identifier: NCT00378118     History of Changes
Other Study ID Numbers: ThrasherRF
IRB00001131 of IORG0000774
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007

Keywords provided by Thrasher Research Fund:

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs