ANRS 12397 Promise-EPI Study: In spite of antiretroviral therapy, ART to HIV-positive mothers, breastfeeding transmission of HIV remains too high in many African countries. Our primary objective is to evaluate the efficacy of an innovative intervention to protect HIV-1-exposed uninfected infants. Prevention of mother-to-child transmission of HIV-1: programme evaluation and innovative rescue intervention integrated in the Expanded Programme of Immunization
A study with three components conducted in Zambia and Burkina Faso, with a high and low HIV prevalence respectively. It has the following three components:
- Component 1: To monitor the ‘real life’ efficacy of the PMTCT cascade up to 2 months post-partum. This involves:
Screening mothers (N=37 000) for HIV (all except known HIV-positive mothers) with a point-of-care test when they come with their 6-8 weeks old baby for vaccination.
- Component 2: To evaluate a reinforced access to early paediatric ART among those HIV-1-infected infants not on ART treatment at EPI visit. Babies of mothers identified as HIV-positive will be tested. If positive, the baby is referred to start antiretroviral therapy, ART.
- Component 3: To evaluate the efficacy of an innovative rescue intervention (including infant PrEP in high risk children) in order to protect HIV-1-exposed uninfected infants against HIV-1 acquisition by breastfeeding. This component is a Phase III, randomized controlled trial, parallel, open-label, multi-country and multi-centre trial (1:1, N=2000) to either standard of care, or intervention, pre-exposure prophylaxis (PrEP), lamivudine. All children will have monthly follow-up visits until 1 year of age.
For more information see ClinicalTrials.gov