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

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
Thrasher Research Fund
ClinicalTrials.gov Identifier:
NCT00378118
First received: September 18, 2006
Last updated: November 5, 2007
Last verified: November 2007
History of Changes
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old

Resource links provided by NLM:

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

Further study details as provided by Thrasher Research Fund:

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

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

Enrollment: 1000
Study Start Date: December 2006
Study Completion Date: September 2007
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
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.

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378118

Locations
Zambia
University Teaching Hospital,Department of Pediatrics
Lusaka, Zambia, P/B RW 1
Sponsors and Collaborators
Thrasher Research Fund
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Catherine M Chunda, Medicine University of Zambia/University Teaching Hospital
  More Information

Additional Information:
This link provides information and guidance on the use of rapid HIV tests  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00378118     History of Changes
Other Study ID Numbers: ThrasherRF, IRB00001131 of IORG0000774
Study First Received: September 18, 2006
Last Updated: November 5, 2007
Health Authority: Zambia: Research Ethics Committee

Keywords provided by Thrasher Research Fund:
HIV-1
HIV-2

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

ClinicalTrials.gov processed this record on May 23, 2013