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.
The study further evaluates if point-of care viral load (PoC VL) testing in mothers at birth can identify high-risk scenarios for Mother to Child Transmission. This should lead to enhanced prophylactic treatments in HIV-exposed infants and hypothesizes that PoC VL monitoring at birth leads to lower transmission rates.
The study is conducted at 28 primary health care facilities in Tanzania and Mozambique, of which half of them will be randomized to provide at-birth HIV PoC EID and maternal PoC VL, the other half will provide the current standard of care (infant HIV testing at 4-8 weeks with no maternal PoC VL monitoring at birth).
This study includes a basic research component that investigates how HIV spreads in the body of HIV-infected infants, and if early infant HIV diagnosis and treatment reduces its spreading in cells of HIV-infected individuals.
- Coordinator: Instituto Nacional de Saude (INS), Mozambique
- Sponsor: Ludwig-Maximillians-Universität (LMU), Germany
- Funder: European and Developing Countries Clinical Trials Partnership (EDCTP), UNITAID, Clinton Health Access Initiative (CHAI).