Validation of Rapid Tests for the Serological Diagnosis of HIV in 9 to 24 Months Old Children
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|ClinicalTrials.gov Identifier: NCT03984552|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment|
|Human Immunodeficiency Virus Transmission Human Immunodeficiency Virus Diagnoses, Syndromes, and Conditions||Behavioral: This was an observational study of medical devices (rapid tests) used for the HIV diagnosis in children up to 2 years|
It concerns a study with a sample composed of children born from HIV positive mothers, age between 9 and 24 months old, with confirmed or discarded infection for HIV determined by molecular testing. Samples from the volunteers will be subjected to rapid tests and serological and molecular reference tests.
After obtaining consent from the child's guardian,a brief interview will take place with completing the questionnaire of inclusion in the research. Then, the collection of fluid in the oral cavity as well as the fingerstick puncture will be conducted for the HIV rapid tests procedures.
The results of the rapid tests will be compared with the ones from the molecular testing and the concordance will be determined for each age group separately.
The study has being conducted by four clinical research sites at Brazil, distributed in three different states, and a clinical research site at Tanzânia: Instituto Fernandes Figueira (IFF - Fiocruz) at Rio de Janeiro; Hospital Geral de Nova Iguaçu (HGNI) at Rio de Janeiro, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD) at Amazonas; Secretaria de Estado de Saúde Pública do Pará (URES - Materno Infantil - UREMIA) at Pará and National Institute for Medical Research (NIMR) at Tanga in Tanzania.
|Study Type :||Observational|
|Estimated Enrollment :||502 participants|
|Official Title:||Validation of Rapid Tests for the Serological Diagnosis of HIV in 9 to 24 Months Old Children|
|Actual Study Start Date :||March 12, 2015|
|Estimated Primary Completion Date :||June 5, 2020|
|Estimated Study Completion Date :||July 31, 2020|
- Behavioral: This was an observational study of medical devices (rapid tests) used for the HIV diagnosis in children up to 2 years
These rapid tests are based on lateral flow immunochromatography technology, in which a nitrocellulose membrane is impregnated with the antigen of interest. The patient sample (blood, serum, plasma, oral fluid, etc.) is applied in this membrane which facilitates the interaction of antibodies in the sample with the antigens on the membrane. This reaction becomes visible to the naked eye thanks to a color developing revelator.
The entire testing process, from sample collection to result reading takes no more than 40 minutes and does not depend on laboratory facilities.
- Efficacy of the Bio-Manguinhos / Fiocruz Rapid DPP® HIV-1/2 Immunoblot [ Time Frame: Day 1 ]Sensitivity and specificity of the Bio-Manguinhos / Fiocruz Rapid DPP® HIV-1/2 Immunoblot, based on the molecular test.
- Efficacy of the Bio-Manguinhos / Fiocruz HIV-1/2 rapid serum screening test [ Time Frame: Day 1 ]Sensitivity and specificity of the Bio-Manguinhos / Fiocruz HIV-1/2 rapid serum screening test in children aged 9 to 24 months, using the Elisa or chemiluminescence and molecular test as reference.
- Efficacy of the rapid Oral Fluid test HIV- 1/2 Bio- Manguinhos [ Time Frame: Day 1 ]Sensitivity and specificity of the rapid Oral Fluid test HIV- 1/2 Bio- Manguinhos in children ,taking as reference molecular testing.
- Variations in the accuracy of rapid tests [ Time Frame: Day 1 ]Covariables of mothers and children
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984552
|Contact: Luiz Antonio J Camacho, DrPHemail@example.com|
|Contact: Tatiana J Fernandes, MScfirstname.lastname@example.org|
|Assessoria Clinica / Bio-Manguinhos / Fiocruz||Recruiting|
|Rio De Janeiro, Brazil, 21.040-360|
|Contact: Tatiana J Fernandes, MSc 552138829489 email@example.com|
|Contact: Robson L Cruz, MSc 5521 3882-9479 firstname.lastname@example.org|
|Principal Investigator:||Luiz Antonio B Camacho, DrPH||Escola Nacional de Saúde Pública - ENSP/Fiocruz|