Implementation of an upgraded strategy to reach zero HIV transmission by breastfeeding in Zambia

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.
The results of this trial were presented at CROI in 2023.

In Zambia, the efficacy of this PMTCT prevention package was tested in Lusaka only, in large MCH sites with frequent supervision and training.

In 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.

Coordinating investigators
Nicolas Nagot (France), Mwiya Mwiya (Zambia) and Rachel King (Uganda).

Work packages
WP1: Coordination (Nicolas Nagot)
WP2: Data Management and statistics (Roselyne Vallo)
WP3: Clinical trial implementation (Mwiya Mwiya)
WP4: Laboratory support (Jean-Pierre Moles)
WP5: Social sciences (Rachel King)
WP6: Health economy (Elly Nuwamanya)
WP7: Capacity strengthening, dissemination and com. (Thorkild Tylleskar)

Funder: EDCTP

Sponsor: UTH (Zambia)