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

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.

Study Overview

• Status: Unknown
• Conditions: Human Immunodeficiency Virus; Human Immunodeficiency Virus Transmission; Diagnoses, Syndromes, and Conditions
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 502

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 21.040-360
    • Recruiting
    • Assessoria Clinica / Bio-Manguinhos / Fiocruz
    • Contact: Tatiana J Fernandes, MSc; Phone Number: 552138829489; Email: tatiana.fernandes@bio.fiocruz.br
    • Contact: Robson L Cruz, MSc; Phone Number: 5521 3882-9479; Email: robson.cruz@bio.fiocruz.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Not applicable

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the Bio-Manguinhos / Fiocruz Rapid DPP® HIV-1/2 Immunoblot	Sensitivity and specificity of the Bio-Manguinhos / Fiocruz Rapid DPP® HIV-1/2 Immunoblot, based on the molecular test.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the Bio-Manguinhos / Fiocruz HIV-1/2 rapid serum screening test	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.	Day 1
Efficacy of the rapid Oral Fluid test HIV- 1/2 Bio- Manguinhos	Sensitivity and specificity of the rapid Oral Fluid test HIV- 1/2 Bio- Manguinhos in children ,taking as reference molecular testing.	Day 1
Variations in the accuracy of rapid tests	Covariables of mothers and children	Day 1

Collaborators and Investigators

• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Luiz Antonio B Camacho, DrPH, Escola Nacional de Saúde Pública - ENSP/Fiocruz

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2015
• Primary Completion (Anticipated): June 5, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: HIV; HIV infection; rapid test; vertical transmission
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Disease; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: ASCLIN 002/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No