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

HIV Antibody Testing Clinical Trial

Official title:

Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378118
• Other study ID #: ThrasherRF
• Secondary ID: IRB00001131 of I
• Status: Completed
• Phase: N/A
• First received: September 18, 2006
• Last updated: November 5, 2007
• Start date: December 2006
• Est. completion date: September 2007

Study information

• Verified date: November 2007
• Source: Thrasher Research Fund
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Antibody Testing

Intervention

Other:
• Abbott-rapid HIV antibody test
Abbott will be used to test serum or whole blood
• OraQuick Rapid HIV-1/2 Antibody test
OraQuick for oral fluid HIV antibody testing

Locations

Country	Name	City	State
Zambia	University Teaching Hospital,Department of Pediatrics	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
Thrasher Research Fund	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the OraQuick rapid test		one year
Secondary	Acceptance of HIV testing using oral fluid		one year

External Links

•   This link provides information and guidance on the use of rapid HIV tests