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.
Coordinating Investigators
Philippe VAN DE PERRE, MD, PhD (France)
Paulin FAO, MD, MPH (Burkina Faso)
Chipepo KANKASA, MD, PhD (Zambia)
Thorkild TYLLESKAR, MD, PhD (Norway)
For more information see ClinicalTrials.gov
PROMISE-EPI protocol
English version ANRS 12397 PROMISE EPI Protocol_V 6.0_30Apr2021
French version ANRS 12397 PROMISE EPI Protocol_V 5.0_28Aout2020