HIV/AIDS Paediatrics
Conditions
Sponsors
Medical Centre of the University of Munich
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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 criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical impact of a PoC-EID - The primary objective is to establish the clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC) on the primary and secondary endpoints. Combined clinical outcomes will include mortality, morbidity (WHO Stage 2 or above disease, severe infant medical conditions), hospitalization, toxicity (Grade 3 or above laboratory abnormality), poor antiretroviral treatment response (confirmed virological failure, treatment termination or prolonged interruption), or loss to follow up of HIVinfected infants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in MTCT-rates in HIV-exposed infants between arms ;Differences in HIV MTCT-rates in HIV-exposed infants between arms | — |
Countries
Mozambique, Tanzania
Contacts
Public ContactAmy Heilman
Clinical Project Manager
Outcome results
None listed