PREVENIR-PEVElimination of Paediatric HIV-1 Infection: Evaluation of the Prevention Programme and Rescue Intervention Based on the Expanded Programme on Immunization (EPI). ANRS 12388 PREVENIR-PEV Study.

The WHO recommendation of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant or breastfeeding women represents a major advance for universal access to HIV care but this strategy alone may not be sufficient to eliminate pediatric HIV in the communities. Presently, the impact of prevention of mother-to-child HIV transmission (PMTCT) programs in the communities is unclear. There is also no available rescue intervention able to identify postpartum women at high risk of transmission in order to offer them adequate HIV care and prevent HIV acquisition by their breastfed infants. We hypothesize that the second visit for routine vaccination (Expanded Program of Immunization visit 2, EPI-2) represents a unique opportunity to link EPI and PMTCT programs and introduce rescue preventive and therapeutic interventions. The study will assess the efficacy of the PMTCT cascade up to 2 months post-partum for all mothers attending the EPI-2 (Component 1). For Component 1, the target population will be all 32,100 women participating in EPI-2 and verbally consenting to participate to evaluate the PMTCT program up to 2 months postpartum. The consent form for component 2 will be proposed to all HIV positive mothers of component 1 who meet the inclusion and non-inclusion criteria. HIV-1 viral load measurement of the mothers and the detection of HIV-1 DNA in their children will be assessed. Children infected with HIV-1 will be referred for immediate ART initiation. For Component 2 - phase IIb trial (N = 300 mother-infant pairs) - the target population will be HIV positive breastfeeding mothers aged 15 years or older with a child whose tests so far do not reveal the existence of infection (at EPI-2 visit) to assess the effectiveness of a rescue intervention for Prevention of Mother-to-Child Transmission of HIV up to 12 months of age. The target population to receive PrEP (lamivudine) until 12 months of age (or until confirmed end of breastfeeding) will be women with unsuppressed HIV-1 infection (≥1000 copies of HIV-1 RNA/ml) with a child whose tests to date (EPI-2 visit) do not reveal the existence of infection. HIV-1 infected women with suppressed (<1000 copies of HIV-1 RNA/ml) viral load at the time of the EPI-2 visit will be followed at 6 and 12 months. If at 6 months the mother become virally unsuppressed, her child will receive ARV medication up to 12 months of age (or the confirmed end of breastfeeding) to prevent infection. The control group does not apply to this study. The overall mother-to-child transmission rate is the WHO target for the elimination of paediatric HIV-1: 5% at one year of life (consistent with a 3% postnatal transmission rate between 2 and 12 months of age of the child).