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

November 5, 2007 updated by: Thrasher Research Fund

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.

Study Overview

Status

Completed

Conditions

HIV Antibody Testing

Intervention / Treatment

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

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Zambia
- - Lusaka, Zambia, P/B RW 1
    - University Teaching Hospital,Department of Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of the OraQuick rapid test Time Frame: one year	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Acceptance of HIV testing using oral fluid Time Frame: one year	one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thrasher Research Fund

Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator: Catherine M Chunda, Medicine, University of Zambia/University Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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. doi: 10.1097/00006454-199609000-00010.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria