The Life Study is a project to evaluate the benefit of HIV testing in neonates born to HIV-infected mothers in Tanzania and Mozambique. For this, novel point-of-care diagnostic systems will be used and evaluated, that can provide neonatal HIV test results within 2 hours. The primary objective of this study is to evaluate if infant PoC birth test & treat interventions have a clinical impact on HIV-infected infant mortality & morbidity as well as on the establishment of viral reservoirs over a follow-up period of 18 months. In this respect the study also investigates how successful modern paediatric HIV treatments can be provided to infants. A special focus concerns if HIV testing and treatment procedures are feasible for nurses and midwives in an African public health environment, if these procedures can be carried out in a timely manner, and if the addition of birth testing is cost-effectiveness for national HIV programmes .
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 (Abbott mPima 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).
The LIFE Study is implemented by a consortium, led by the Mozambican Ministry of Health’s Instituto Nacional de Saúde (INS). It comprises highly recognized institutions with complementary expertise including study conduct (INS, NIMR, LMU), HIV virology (IUEM, LMU), implementation of large scale care and treatment programs (CHAI) and policy making (INS, NIMR, CHAI). All partners have been collaborating for many years in several successful projects and some of their studies in the field of point-of-care diagnostics have provided evidence for WHO Guidelines.
The study will be implemented in 14 sites in Mozambique and 14 sites in Tanzania. The sites were randomized to two arms: control and intervention arm.