Human Immunodeficiency Virus TransmissionNCT03984552
Validation of Rapid Tests for the Serological Diagnosis of HIV in 9 to 24 Months Old Children
An observational study of Human Immunodeficiency Virus Transmission and Human Immunodeficiency Virus, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 24 months
- Conditions the study is for
- Human Immunodeficiency Virus Transmission, Human Immunodeficiency Virus, Diagnoses, Syndromes, and Conditions
- What is being tested?
- This was an observational study of medical devices (rapid tests) used for the HIV diagnosis in children up to 2 years
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 502 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Mar 2015to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 24 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Children must be born from a HIV infected mother; Molecular diagnostic tests available.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Assessoria Clinica / Bio-Manguinhos / Fiocruz
Rio de Janeiro, 21.040-360
Tatiana J Fernandes, MSc, 552138829489, tatiana.fernandes@bio.fiocruz.br
Robson L Cruz, MSc, 5521 3882-9479, robson.cruz@bio.fiocruz.br
About this study
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.
Read the 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
- Being tested
- This was an observational study of medical devices (rapid tests) used for the HIV diagnosis in children up to 2 years
- Keywords
- HIV, rapid test, HIV infection, vertical transmission
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Disease, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This was an observational study of medical devices (rapid tests) used for the HIV diagnosis in children up to 2 yearsBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
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.
Measured: 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.
Measured: Day 1
Variations in the accuracy of rapid tests
Covariables of mothers and children
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start12 Mar 2015
- Primary completion5 Jun 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus TransmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Luiz Antonio B Camacho, DrPH, Principal investigator, Escola Nacional de Saúde Pública - ENSP/Fiocruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984552
- Sponsor's protocol ID
- ASCLIN 002/2012
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Rapid Tests for the Serological Diagnosis of HIV in 9 to 24 Months Old Children
- ClinicalTrials.gov ID
- NCT03984552
- Acronym / sponsor ID
- ASCLIN 002/2012
- Conditions
- Human Immunodeficiency Virus Transmission, Human Immunodeficiency Virus, Diagnoses, Syndromes, and Conditions
- Keywords
- HIV, rapid test, HIV infection, vertical transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 5 Jun 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- Children must be born from a HIV infected mother; Molecular diagnostic tests available.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This was an observational study of medical devices (rapid tests) used for the HIV diagnosis in children up to 2 yearsThese 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. | Behavioural | – |
Primary outcome
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.
3 secondary outcomes
Efficacy of the Bio-Manguinhos / Fiocruz HIV-1/2 rapid serum screening test
Time frame: Day 1
Efficacy of the rapid Oral Fluid test HIV- 1/2 Bio- Manguinhos
Time frame: Day 1
Variations in the accuracy of rapid tests
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Antonio B Camacho, DrPH principal investigator
Escola Nacional de Saúde Pública - ENSP/Fiocruz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Transmission and Human Immunodeficiency Virus, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz Antonio J Camacho, DrPH (+552125982630, luiz.camacho@ensp.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the Bio-Manguinhos / Fiocruz Rapid DPP® HIV-1/2 Immunoblot (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.