Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Rapid Tests for the Serological Diagnosis of HIV in 9 to 24 Months Old Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984552
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Brief Summary:
Antiretroviral therapy of the mother and of the newborn associated with alternative schemes of breastfeeding can reduce these transmission rates to 1%. The diagnosis of HIV infection in newborns is based on PCR for detection of viral genetic material, a procedure that is expensive and of complex logistics. Tests based on detection of antibodies are faster and cheaper but cannot distinguish infected child or maternal antibodies passed to the fetus through the placenta. Nevertheless, the so-called rapid tests have been implemented in the network of health services because of their simplicity and performance comparable to conventional tests. DPP HIV 1/2 test, produced by Bio-Manguinos/Fiocruz, usage is limited by the manufacturer to over 24 months of age children, though the guidelines control programs already recommend the use from 18 months in Brazil and 9 months in other countries. Data on the accuracy of the rapid test under 24 months of age are scarce. This proposal aims to assess the performance of rapid tests produced by Bio-Manguinhos in diagnostic protocols for HIV infection in children 9-24 months old, in order to obtain empirical data to support the current recommendations on rapid tests, particularly in countries with limited access to tests that require specialized laboratories. The validation of rapid HIV testing in other age groups is a requirement of the national regulatory authorities, and has important implications for programs to control HIV-AIDS in populations from countries with limited access to specialized laboratory resources. The use of the rapid test can also represent a significant reduction in costs, as it allows limiting the use of molecular tests to complex and expensive confirmation cases.

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

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 502 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Variations in the accuracy of rapid tests [ Time Frame: Day 1 ]
    Covariables of mothers and children


Biospecimen Retention:   Samples With DNA
First, a sample of oral fluid for the RT DPP HIV 1/2 will be harvested.Then, the blood from the finger stick will be used to perform RT DPP HIV 1 / 2 ® and rapid imunoblot HIV 1/ 2(IB).The results of the rapid tests will be available in up to 30 minutes and will be recorded in specific forms for further analysis of concordance with the molecular results. The blood samples and parts of them (serum and plasma) collected in this study will be used only for the examinations foreseen in this research project and will be kept under the responsibility of the researcher Dr. Luiz Antonio Bastos Camacho in Bio-Manguinhos / Fundação Oswaldo Cruz for 10 years.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

502 children born from a HIV infected mother, divided in the following groups:

  1. 251 HIV infected children, divided in the following subgroups:

    1. 9-15 months old;
    2. 16-21 months old;
    3. 22-24 months old
  2. 251 HIV non infected children, divided in the following subgroups:

    1. 9-15 months old;
    2. 16-21 months old;
    3. 22-24 months old
Criteria

Inclusion Criteria:

Children must be born from a HIV infected mother; Molecular diagnostic tests available.

Exclusion Criteria:

Not applicable


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984552


Contacts
Layout table for location contacts
Contact: Luiz Antonio J Camacho, DrPH +552125982630 luiz.camacho@ensp.fiocruz.br
Contact: Tatiana J Fernandes, MSc +552138829489 tatiana.fernandes@bio.fiocruz.br

Locations
Layout table for location information
Brazil
Assessoria Clinica / Bio-Manguinhos / Fiocruz Recruiting
Rio De Janeiro, Brazil, 21.040-360
Contact: Tatiana J Fernandes, MSc    552138829489    tatiana.fernandes@bio.fiocruz.br   
Contact: Robson L Cruz, MSc    5521 3882-9479    robson.cruz@bio.fiocruz.br   
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Layout table for investigator information
Principal Investigator: Luiz Antonio B Camacho, DrPH Escola Nacional de Saúde Pública - ENSP/Fiocruz

Layout table for additonal information
Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT03984552     History of Changes
Other Study ID Numbers: ASCLIN 002/2012
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):
HIV
rapid test
HIV infection
vertical transmission

Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Disease
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Pathologic Processes