Project: Prevention Of Mother-To-Child Transmission Of Hiv-1: Program Evaluation And Innovative Rescue Intervention Integrated In The Expanded Program Of Immunization

Acronym PROMISE-EPI (Reference Number: RIA2016MC-1617)
Duration 01/05/2018 - 30/04/2021
Project Topic The WHO recommendation of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant/lactating women together with a six-week nevirapine pre-exposure prophylaxis (PrEP) in infants is implemented in most African countries since 2013, with the aim to eliminating paediatric HIV. Despite this B+ strategy, UNAIDS estimated by modelling that, among 21 target African countries, the average residual HIV-1 transmission rate was about 14% at 12 month in 2015, incompatible with paediatric HIV elimination. In Burkina Faso and in Zambia, close to 100% of 6-8 weeks old babies and their mothers attend the first visit of the Expanded Program of Immunization (EPI-1), representing a unique opportunity to integrate rescue PMTCT interventions. The PROMISE-EPI study objectives are: - To monitor the performance of the PMTCT cascade until 2 months post-partum, in a quasi-community-based manner: - To detect early HIV-1-infected children by point-of-care (POC) test and initiate immediate ART; - To assess the benefits, risk and cost of a PMTCT rescue intervention consisting of detecting women able to transmit HIV-1 with a POC test, during the fist immunization visit of their child. The study combines: 1. A cross-sectional assessment of the PMTCT program up to 2 months post-partum, by a standardized questionnaire capturing the PMTCT exposure, and a HIV-1 rapid test for all mothers attending the EPI- 1, and for those infected, measuring HIV-1 viral load and POC HIV-1 DNA in their babies. 2. Referral of all HIV-infected children for immediate ART. 3. A Phase III randomised controlled trial targeting uninfected exposed infants, comparing a rescue strategy consisting of POC maternal viral load at 2 and 6 months prompting infant PrEP using oral lamivudine when >1000 copies/mL, along with referral to maternal HIV-1 care for ART initiation or optimisation vs. routine B+ implementation. The primary outcome of the RCT is HIV-1 postnatal transmission rate at 12 months. Secondary outcomes are safety (adverse effect rate at 12 months) and cost-effectiveness. This study will include approximately 37,000 mothers/infants attending EPI-1 in Bobo-Dioulasso, Burkina Faso and Lusaka, Zambia. 2000 HIV-1-infected mothers and their infants will be randomised, allowing to detect at least 50% intervention efficacy, with 80% power, an alpha error of 5% and 15% lost to follow-up. This study aspires to optimise existing PMTCT strategies, with integration of PMTCT and EPI programs as the most innovative component. Clinical trial capacity development will be an integral part of the project.
Network EDCTP2
Call Clinical trials and operational research studies to optimise the use of products for poverty-related diseases in mothers, newborns, children and/or adolescents

Project partner

Number Name Role Country
1 l'Institut national de la santé et de la recherche médicale (INSERM) Coordinator France
2 University of Bergen Partner Norway
3 University Teaching Hospital Partner Zambia
4 Centre MURAZ Partner Burkina Faso