Validation of Rapid Tests for the Serological Diagnosis of HIV in 9 to 24 Months Old Children
1 other identifier
observational
502
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedJune 13, 2019
June 1, 2019
5.2 years
June 11, 2019
June 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Efficacy of the Bio-Manguinhos / Fiocruz HIV-1/2 rapid serum screening test
Day 1
Efficacy of the rapid Oral Fluid test HIV- 1/2 Bio- Manguinhos
Day 1
Variations in the accuracy of rapid tests
Day 1
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- Children must be born from a HIV infected mother; Molecular diagnostic tests available.
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assessoria Clinica / Bio-Manguinhos / Fiocruz
Rio de Janeiro, 21.040-360, Brazil
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luiz Antonio B Camacho, DrPH
Escola Nacional de Saúde Pública - ENSP/Fiocruz
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 13, 2019
Study Start
March 12, 2015
Primary Completion
June 5, 2020
Study Completion
July 31, 2020
Last Updated
June 13, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share