NCT04032522

Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID- Long Term Impact on inFant hEalth (LIFE)

Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID - Long Term Impact on inFant hEalth: a Feasibility Study of point-of Care Testing at Birth Versus at 6 Weeks of Age, on the Uptake of ART and Infant Prophylaxis, and on Rates of Infant Survival, Morbidity and Retention in Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,602 (actual)
• Sponsor: Michael Hoelscher · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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, that can provide neonatal HIV test results within 2 hours. We will evaluate if HIV testing at birth followed by immediate neonatal HIV treatment initiation will lead to lesser infant's sickness, HIV progression or even death as compared to the current standard procedure which is infant HIV testing at week 6 after delivery. This will be associated with a cost-effectiveness analysis in order to guide national HIV programs for their guidelines. The study will further evaluate if point-of care viral load testing in mothers at birth will identify high-risk scenarios for HIV transmission from the mother to her child. This should lead to enhanced prophylactic treatments in HIV-exposed infants and we hypothesize that PoC VL monitoring at birth leads to lower transmission rates. The study will be performed at 28 maternity health facilities in Tanzania and Mozambique, half of them will be randomized to provide birth HIV PoC infant and maternal viral load testing, the other half will provide the current standard of care (infant HIV testing at week 6, no PoC VL monitoring at birth for the mother). The study is conducted in public health settings, and some study objectives also focus on how successful modern HIV treatments can be provided to infants, if HIV testing and treatment procedures are feasible for nurses and midwives, and if these procedures can be carried out in a timely manner. This study also includes a basic research component that will investigate how HIV spreads in the body of HIV-infected infants, and if early infant HIV diagnosis and treatment can reduce the spread in cells of HIV-infected individuals.

Conditions

• HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)

Interventions

Type	Name	Description
OTHER	point-of care (PoC) neonatal HIV early infant diagnosis (EID)	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)

Timeline

• Start date: 2019-10-23
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2019-07-25
• Last updated: 2024-08-22

Locations

2 sites across 2 countries: Mozambique, Tanzania