Pediatric HIV elimination: program evaluation and EPI‐based rescue interventions
BACKGROUND: 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.
GAP: 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.
HYPOTHESIS: We hypothesize that the first visit for routine vaccination (Expanded Program of Immunization visit 1, EPI-1) represents a unique opportunity to link EPI and PMTCT programs and introduce rescue preventive and therapeutic interventions.
METHODS: The study combines
1. A cross-sectional assessment of the PMTCT program up to 2 months post-partum, using a standardized questionnaire and a HIV-1 rapid test for all mothers attending the EPI-1, and for those infected, measuring HIV-1 viral load and HIV-1 RNA/DNA in their babies. HIV-infected children will be referred for immediate ART;
2. An open-label Phase IIb trial targeting uninfected infants born to mothers with unsuppressed HIV-1 infection, combining referral to maternal ART initiation or adherence support and daily oral infant emtricitabine until the end of breastfeeding. Follow-up visits will be scheduled at 6 and 12 months.
This study will screen 30,000 mothers/infants pairs attending EPI -1 in Bobo-Dioulasso, Burkina Faso. Overall, 150 HIV-infected women without suppressive ART will be enrolled in the Phase IIb trial.
IMPACT: By integrating PMTCT and EPI programs, this study will estimate the efficacy of the current PMTCT program and pilot a rescue intervention that could much improve the current strategy towards pediatric HIV elimination.