Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID- Long Term Impact on inFant hEalth (LIFE)
- Conditions
- HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)
- Registration Number
- NCT04032522
- Lead Sponsor
- Michael Hoelscher
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 6602
Inclusion Criteria:<br><br> 1. Voluntary and informed consent of the mother for her own study participation<br><br> 2. Voluntary and informed consent of the legal guardian of the child for participation<br> of the child in the study.<br><br> 3. Mothers/legal guardians =18 years of age.<br><br> 4. Documented maternal HIV infection.<br><br> 5. Willingness to consent to HIV testing for the child and herself.<br><br> 6. Willingness to consent to active tracing including home tracing.<br><br>Exclusion Criteria:<br><br> 1. Deficiency in the mother, rendering it difficult, if not impossible, for her or her<br> infant to take part in the study or understand the information provided to her. This<br> includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal<br> tendencies or any other inability.<br><br> 2. Having delivered more than 72h (3 days) ago<br><br> 3. Prisoners<br><br> 4. Women presenting with an emergency requiring immediate medical assistance if not<br> resolved at study inclusion<br><br> 5. Stillbirths<br><br> 6. Infant requiring emergency care (e.g. immediate or rapid occurring life threatening<br> conditions, resuscitation, prolonged obstetric related intensive care, severe<br> jaundice) or born with severe malformation.<br><br> 7. If within the discretion of the investigator based on recommendation of the<br> gynaecologist or paediatrician in charge study participation would possibly add not<br> acceptable risk or burden to the mother or infant (e.g. significant congenital<br> malformation, health deficiencies, very low birth weight less than 1500g)<br><br> 8. Unlikely to comply with protocol as judged by the principal investigator or his<br> designate
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical impact of a PoC-EID
- Secondary Outcome Measures
Name Time Method