Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old
|First Submitted Date||September 18, 2006|
|First Posted Date||September 19, 2006|
|Last Update Posted Date||November 6, 2007|
|Start Date||December 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Sensitivity and specificity of the OraQuick rapid test [ Time Frame: one year ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00378118 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Acceptance of HIV testing using oral fluid [ Time Frame: one year ]|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old|
|Official Title||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.
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 Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|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|
|Condition||HIV Antibody Testing|
|Study Groups/Cohorts||Not Provided|
|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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||September 2007|
|Primary Completion Date||Not Provided|
|Ages||up to 18 Months (Child)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Zambia|
|Removed Location Countries|
|Other Study ID Numbers||ThrasherRF
IRB00001131 of IORG0000774
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||Thrasher Research Fund|
|Collaborators||Centers for Disease Control and Prevention|
|PRS Account||Thrasher Research Fund|
|Verification Date||November 2007|