Skip to main content
OpenTrials
Completed

NCT Number: NCT00378118

Use of OraQuick for Screening HIV 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Antibody Testing

Age range

1 day–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University Teaching Hospital,Department of Pediatrics

Lusaka, Lusaka Province, P/B RW 1, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abbott-rapid HIV antibody test

Other

Abbott will be used to test serum or whole blood

OraQuick Rapid HIV-1/2 Antibody test

Other

OraQuick for oral fluid HIV antibody testing

Primary outcomes

  1. Sensitivity and specificity of the OraQuick rapid test

    Time frame: one year

Secondary outcomes

  1. Acceptance of HIV testing using oral fluid

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Thrasher Research Fund

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Sep 19, 2006
Registry last updated
Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.