Status:
COMPLETED
Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID- Long Term Impact on inFant hEalth (LIFE)
Lead Sponsor:
Michael Hoelscher
Collaborating Sponsors:
Instituto Nacional de Saúde, Mozambique
NIMR- Mbeya Medical Research Centre (MMRC), Mbeya, Tanzania
Conditions:
HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)
Eligibility:
FEMALE
18+ years
Brief Summary
This study we will evaluate the benefit of HIV testing in neonates born from HIV-infected mothers in Tanzania and Mozambique. The study will use and evaluate novel point-of-care diagnostic systems, th...
Eligibility Criteria
Inclusion
- Voluntary and informed consent of the mother for her own study participation
- 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.
- Willingness to consent to active tracing including home tracing.
Exclusion
- 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 72h (3 days) ago
- Prisoners
- Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion
- Stillbirths
- Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) 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
Key Trial Info
Start Date :
October 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
6602 Patients enrolled
Trial Details
Trial ID
NCT04032522
Start Date
October 23 2019
End Date
January 1 2023
Last Update
August 22 2024
Active Locations (2)
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1
Centro de Investigacao Operacional da Beira (CIOB)
Beira, Sofala, Mozambique
2
Mbeya Medical Research Centre
Mbeya, Tanzania