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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02545296 |
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Date of registration:
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08/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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HIV Point-of-Care Test Evaluation in Infants
BABY |
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Scientific title:
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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 |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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604 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02545296 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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Michael Hoelscher, Prof Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Centre of the University of Munich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Voluntary and informed consent of the mother for her own study participation (if
applicable).
2. Voluntary and informed consent of the legal guardian of the child for participation of
the child in the study.
3. Mothers/legal guardians =18 years of age.
4. Documented maternal HIV infection.
5. Willingness to consent to HIV testing for the child and herself (if applicable).
6. Willing to consent to active tracing including home tracing.
Exclusion Criteria:
1. 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.
2. Having delivered more than 48h ago
3. Prisoners
4. Women presenting with an emergency requiring immediate medical assistance if not
resolved at study inclusion.
5. Stillbirths
6. Infant requiring emergency care or born with severe malformation.
7. 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)
8. Unlikely to comply with protocol as judged by the principal investigator or his
designate
Age minimum:
N/A
Age maximum:
48 Hours
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Intervention(s)
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Other: In-vitro Diagnostics
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Primary Outcome(s)
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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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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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Secondary ID(s)
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LMU-IMPH-BABY-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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