HIV Antibody TestingNCT00378118
Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old
An observational study of HIV Antibody Testing, run by Thrasher Research Fund at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 months
- Conditions the study is for
- HIV Antibody Testing
- What is being tested?
- Abbott-rapid HIV antibody test and OraQuick Rapid HIV-1/2 Antibody test
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteZambia
- Study dates
- Dec 2006to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Children admitted to the University Teaching Hospital,Lusaka,Zambia with various illnesses and aged less than 18 months old
Who may be able to join
- 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
Who cannot join
- Age of more than 18 months
- Refusal of consent by caregiver
- Outpatients
Trial locations and contacts
1 site in 1 country.
Zambia1 site
University Teaching Hospital,Department of Pediatrics
Lusaka, Lusaka Province, P/B RW 1
About this study
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.
Read the 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.
- Conditions
- HIV Antibody Testing
- Being tested
- Abbott-rapid HIV antibody test, OraQuick Rapid HIV-1/2 Antibody test
- Keywords
- HIV-1, HIV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott-rapid HIV antibody testOther
Abbott will be used to test serum or whole blood
OraQuick Rapid HIV-1/2 Antibody testOther
OraQuick for oral fluid HIV antibody testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the OraQuick rapid test
Measured: one year
Secondary outcomes (1)
Acceptance of HIV testing using oral fluid
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startDec 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Antibody TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thrasher Research Fund
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Catherine M Chunda, Medicine, Principal investigator, University of Zambia/University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378118
- Sponsor's protocol ID
- ThrasherRF
- Other IDs
- IRB00001131 of IORG0000774
- Status last verified
- Nov 2007
- First submitted
- 18 Sep 2006
- Last updated
- 6 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 8878222
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of OraQuick in Children Less Than Eighteen Months Old
- ClinicalTrials.gov ID
- NCT00378118
- Acronym / sponsor ID
- ThrasherRF
- Conditions
- HIV Antibody Testing
- Keywords
- HIV-1, HIV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Thrasher Research FundUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Dec 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 19 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children admitted to the University Teaching Hospital,Lusaka,Zambia with various illnesses and aged less than 18 months old
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age of more than 18 months
- Refusal of consent by caregiver
- Outpatients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott-rapid HIV antibody testAbbott will be used to test serum or whole blood | Other | – |
| OraQuick Rapid HIV-1/2 Antibody testOraQuick for oral fluid HIV antibody testing | Other | – |
Primary outcome
Sensitivity and specificity of the OraQuick rapid test
Time frame: one year
1 secondary outcome
Acceptance of HIV testing using oral fluid
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2007.
- Background: PubMed 8878222Tess 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.
- This link provides information and guidance on the use of rapid HIV testsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine M Chunda, Medicine principal investigator
University of Zambia/University Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Antibody Testing, run by Thrasher Research Fund at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the OraQuick rapid test (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2007.