Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment

Launched by MICHAEL HOELSCHER · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on improving healthcare for mothers living with HIV and their newborns in Tanzania and Mozambique. Researchers want to find out if better testing for HIV in pregnant women, especially checking the level of the virus in their blood during delivery, can help identify more mothers and babies at risk of passing the virus from mother to child. The study also aims to ensure that high-risk infants receive the right care and prevention strategies. By expanding testing services to rural areas, the goal is to make it easier for families to access the care they need.

To participate in the study, mothers must be at least 18 years old, have a documented HIV infection, and agree to have both themselves and their baby tested for HIV. They should also be willing to allow health workers to follow up with them at home. Unfortunately, some groups of people, like those who have just delivered their baby more than three days ago or those with serious health issues, cannot take part in the study. If eligible, participants can expect support and guidance throughout the process to help ensure the health and well-being of both mother and child.

Gender

FEMALE

Eligibility criteria

• 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 (or just her child); and
• • 6. Willingness to consent to active tracing including home tracing.
• Exclusion Criteria:
• • 7. 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.
• • 8. Having delivered more than 72h (3 days) ago;
• • 9. Prisoners;
• • 10. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion;
• • 11. Stillbirths;
• • 12. 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;
• • 13. 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
• • 14. Unlikely to comply with protocol as judged by the principal investigator or his designate