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

Informazioni relative al progetto

PROMISE-ZERO

ID dell’accordo di sovvenzione: 101103295

DOI

10.3030/101103295

Data della firma CE 2 Marzo 2023

Data di avvio 1 Luglio 2023

Data di completamento 30 Giugno 2027

Finanziato da

• Health

Costo totale

€ 3 995 300,00

Contributo UE

€ 3 995 300,00

Coordinato da

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)

Periodo di rendicontazione: 2023-07-01 al 2024-12-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

Not applicable