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The PROMISE-ZERO study

Most cases of paediatric HIV now occur during the breastfeeding period. In the last twenty years, considerable progress has been achieved to improve policies and scale up the roll out of strategies to prevent mother-to-child transmission of HIV. The primary objective of the study is to assess the effectiveness of an optimised strategy for the prevention of postnatal mother-to-child transmission.

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The PROMISE-ZERO implementation study is built on the success of previous proof-of-concept studies, PROMISEPEPand PROMISE-EPI trials, funded by EDCTP and EDCTP-2 programs, respectively.

The PROMISE-EPI trial assessed a post-natal prevention package for prevention of mother to child transmission (PMTCT) of HIV in Zambia and Burkina Faso. The intervention consisted of Point of Care (POC) for early infant diagnosis (EID) and maternal viral load (mVL) at EPI-2 and M6, followed by an immediate initiation of a single prophylaxis (lamivudine) in case of unsuppressed viral load.

In the PROMISE-ZERO study, we hypothesize that this PMTCT prevention package is equally efficient when implemented in more challenging and ‘real-life’ settings.To test this hypothesis, an implementation study will be implemented with objectives based on the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance).

The design of PROMISE-ZERO study includes a pre-implementation phase (qualitative measure), a randomized trial clustered by Maternal and Child Health centers (MCHs), a health economic component, a qualitative component during the trial, collection of data from routine registries and a climate impact evaluation.

The PROMISE-ZERO study will be carried out in 2 MCHs of Lusaka and 26 MCHs or the Eastern Province.

The objectives of PROMISE-ZERO are particularly relevant to the current PMTCT policyand practice as they propose a new paradigm of postnatal transmission eradication. In addition, the results of this project will be useful to other countries and help reduce the research gaps identified by the WHO in PMTCT.