Checking HIV levels in mothers at delivery to find newborns at risk
Tests whether checking HIV levels in mothers at delivery finds newborns at risk.
Plain-language title generated from the registry record
Registry title: Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
Key facts
- Where
- Mbeya, TanzaniaSee the site
Where in Tanzania
- National Institute for Medical Research (NIMR)Mbeya, TanzaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Michael Hoelscher
- Trial code
- NCT06267508
- Record updated
- 18 November 2024
- Original description
This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.Read full original descriptionShow less
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.
Inclusion: 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 (or just her child); and; Willingness to consent to active tracing including home tracing.
Exclusion: 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; 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; 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; 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); or; Unlikely to comply with protocol as judged by the principal investigator or his designate.