Implementation of an upgraded strategy to reach zero HIV transmission by breastfeeding in rural and urban settings in Zambia – the PROMISE-ZERO study

Project Information

PROMISE-ZERO

Grant agreement ID: 101103295

DOI

10.3030/101103295

EC signature date 2 March 2023

Start date 1 July 2023

End date 30 June 2027

Funded under

• Health

Total cost

€ 3 995 300,00

EU contribution

€ 3 995 300,00

Coordinated by

UNIVERSITE DE MONTPELLIER
France

Periodic Reporting for period 1 - PROMISE-ZERO (Implementation of an upgraded strategy to reach zero HIV transmission by breastfeeding in rural and urban settings in Zambia – the PROMISE-ZERO study)

Reporting period: 2023-07-01 to 2024-12-31

Summary of the context and overall objectives of the project

PROMISE-ZERO is a hybrid effectiveness/implementation research study designed to achieve near-zero HIV transmission through breastfeeding in urban and rural Zambia. The study builds on an intervention previously tested in a phase 3 clinical trial, combining facilitation of maternal viral load monitoring (using POC) and single-drug infant post-natal prophylaxis for at-risk infants.
PROMISE-ZERO study consists of a cluster randomized clinical trial a qualitative component (through focus group discussions and individual interviews), a health economic component, and an environmental impact component.
The primary objective of PROMISE-ZERO is to assess the effectiveness of an optimised strategy to prevent postnatal mother-to-child transmission of HIV.
The secondary objectives are related to the implementation of the intervention using the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework with endpoints issued from all components.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The pre-implementation study was set up as planned with the drafting of the social sciences protocol, the regulatory approvals and collection of the data and preliminary analyses. This pre-implementation study explored how to better tailor the procedures of PROMISE-ZERO trial for greater public health impact. It also provided the first answers to RE-AIM’s secondary objectives from a social sciences perspective. These results will be complemented by the qualitative component embedded in the clinical trial, in order to obtain comprehensive results at the end of the trial.
The various working packages worked in close collaboration, with weekly meetings, to set up the clinical trial under the best possible conditions and as quickly as possible. However, delays in regulatory approvals prevented us from starting on schedule. We are nonetheless pleased to report that the latest authorization was granted on January 09, 2025 (outside the period covered by this report), and we are putting everything in place to start the trial as soon as possible, hopefully in early March.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Not applicable