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

NCT ID: NCT03984552

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 502 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-12
• Study Completion Date: 2020-07-31

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.

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.

Conditions

Human Immunodeficiency Virus Transmission; Human Immunodeficiency Virus; Diagnoses, Syndromes, and Conditions

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Not applicable

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luiz Antonio B Camacho, DrPH

Role: PRINCIPAL_INVESTIGATOR

Escola Nacional de Saúde Pública - ENSP/Fiocruz

Locations

Assessoria Clinica / Bio-Manguinhos / Fiocruz

Rio de Janeiro, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Luiz Antonio J Camacho, DrPH

Role: CONTACT

luiz.camacho@ensp.fiocruz.br

+552125982630

Tatiana J Fernandes, MSc

Role: CONTACT

tatiana.fernandes@bio.fiocruz.br

+552138829489

Facility Contacts

Tatiana J Fernandes, MSc

Role: primary

tatiana.fernandes@bio.fiocruz.br

552138829489

Robson L Cruz, MSc

Role: backup

robson.cruz@bio.fiocruz.br

5521 3882-9479

Other Identifiers

ASCLIN 002/2012

Identifier Type: -

Identifier Source: org_study_id