Project: Neonatal HIV early infant diagnosis (EID) versus standard of care EID – 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.

Acronym	LIFE Study (Reference Number: RIA2016MC-1615)
Duration	01/06/2018 - 31/05/2023
Project Topic	Despite significant recent progress, access to HIV diagnosis and antiretroviral therapy (ART) for HIV-exposed infants remains suboptimal. This is mainly due to two factors: complex centralized laboratory testing procedures and poor linkage to infant care and treatment. The availability of novel Point-of-care (PoC) Early Infant Diagnosis (EID) instruments (Alere Q and Cepheid GeneXpert) enables nurse-based, decentralized testing with the potential to improve health outcomes. PoC-EID has been recommended in the latest 2016 WHO guidelines, however, this is a conditional recommendation due to lack of implementation experience. These guidelines also recommend viral load (VL) for ART monitoring especially in pregnant and breastfeeding women because of the added benefit to prevent HIV mother-to-child transmission (MTCT). PoC maternal VL at delivery could increase early detection of high-risk situations and uptake of enhanced postnatal prophylaxis (PNP). While PoC virologic tests may enable new models of care, implementation needs to answer three questions: - Does birth PoC-EID compared with Standard-of-Care (SoC) increase uptake of ART and improve outcomes of infant morbidity, mortality and retention in care? - Does PoC-VL testing at delivery result in lower MTCT rates through the use of enhanced PNP? - What are the costs and operational elements that must be understood in order to plan for national scale up? We propose a cluster-randomized trial in 24 primary health care facilities in Mozambique and Tanzania. Twelve sites will implement a package of interventions including maternal PoC-VL testing, birth PoC-EID, and very early nurse-initiated ART. The other 12 sites will follow the SoC for HIV-exposed newborns, including EID testing at 4- 8 weeks, followed by ART in infants who test positive. The study will compare the proportion and timing of infants starting ART, the impact of maternal VL testing on access to PNP and MTCT rates, and assess their association with infant HIV outcomes: mortality, morbidity, retention and treatment success over 18 months. We will collect cost and feasibility data across all sites to inform national scale up plans, and assess the impact of interventions on the size and dynamics of the latent viral reservoir in infected infants. The members of the consortium, including two African research and public health institutions from Mozambique and Tanzania, the Clinton Health Access Initiative (CHAI) and two European universities (LMU, Munich and ISCSEM, Lisbon), have ample experience in HIV diagnosis and clinical service delivery and are well positioned to rapidly incorporate evidence generated by this study into national and global policy.
Network	EDCTP2
Call	Clinical trials and operational research studies to optimise the use of products for poverty-related diseases in mothers, newborns, children and/or adolescents

Project partner

Number	Name	Role	Country
1	Instituto Nacional de Saúde	Coordinator	Mozambique
2	Clinton Health Access Initiative	Partner	United States
3	Egas Moniz - Cooperativa de Ensino Superior, CRL	Partner	Portugal
4	Ludwig-Maximilians-Universitaet Muenchen	Partner	Germany
5	National Institute for Medical Research - Tanzania	Partner	Tanzania