HIV Point-of-Care Test Evaluation in Infants (BABY)
March 6, 2018 updated by: Michael Hoelscher
HIV Point-of-Care Tests in Babies Study (BABY) - Operational Evaluation of HIV Point-of-Care Tests for Very Early Infant HIV Diagnostics in Infants Born to HIV Infected Mothers in Mbeya, Tanzania
HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.
Study Overview
Detailed Description
This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania.
Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya over a time period of 12 months. The HIV PoC test will be validated against the Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses.
The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.
Study Type
Interventional
Enrollment (Actual)
604
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mbeya, Tanzania
- NIMR - Mbeya Medical Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 2 days (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Voluntary and informed consent of the mother for her own study participation (if applicable).
- Voluntary and informed consent of the legal guardian of the child for participation of the child in the study.
- Mothers/legal guardians ≥18 years of age.
- Documented maternal HIV infection.
- Willingness to consent to HIV testing for the child and herself (if applicable).
- Willing to consent to active tracing including home tracing.
Exclusion Criteria:
- Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
- Having delivered more than 48h ago
- Prisoners
- Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion.
- Stillbirths
- Infant requiring emergency care or born with severe malformation.
- If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g)
- Unlikely to comply with protocol as judged by the principal investigator or his designate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: In-vitro Diagnostics
All infants are recruited into the same arm.
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Ex-vivo performed diagnostic blood based test.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Specificity of PoC HIV test
Time Frame: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
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Specificity of the PoC HIV test
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Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
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Sensitivity of PoC HIV test
Time Frame: Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
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Sensitivity of the PoC HIV test
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Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Michael Hoelscher, Prof Dr, Medical Centre of the University of Munich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
July 8, 2015
First Submitted That Met QC Criteria
September 7, 2015
First Posted (Estimate)
September 9, 2015
Study Record Updates
Last Update Posted (Actual)
March 7, 2018
Last Update Submitted That Met QC Criteria
March 6, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LMU-IMPH-BABY-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.