Why is this study being done?

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). 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?