Implementing Primaquine Single Low Dose in Africa

Project Information

IMPRIMA

Grant agreement ID: 101103213

DOI

10.3030/101103213

EC signature date 21 March 2023

Start date 1 April 2023

End date 31 March 2027

Funded under

• Health

Total cost

€ 3 969 906,25

EU contribution

€ 3 967 406,25

Coordinated by

UNIVERSITE DE STRASBOURG
France

Periodic Reporting for period 1 - IMPRIMA (Implementing Primaquine Single Low Dose in Africa)

Reporting period: 2023-04-01 to 2024-09-30

Summary of the context and overall objectives of the project

In the World Malaria Report 2023, the number of clinical malaria cases is estimated to reach 249 million, with 608,000 deaths, a 10% increase from 2019 and a timely reminder to maintain good malaria control and implement new elimination strategies. To further reduce malaria transmission and potentially achieve elimination, the World Health Organization (WHO) recommended in 2012 the addition of single low-dose primaquine (SLDPQ) to artemisinin-based combination therapies (ACTs), particularly in low transmission settings and, more recently, in regions where artemisinin partial resistance is emerging. SLDPQ is effective in eradicating mature gametocytes, thereby interrupting the transmission cycle between human hosts and mosquito vectors, which is expected to lead to a significant reduction in the burden of malaria if used widely. The suboptimal uptake of SLDPQ is exacerbated by the lack of child-friendly formulations of primaquine and continuing concerns about the potential for acute haemolysis associated with primaquine in individuals with glucose-6-phosphate dehydrogenase deficiency. Building upon the progress of the 'Developing Paediatric Primaquine' (DPP) project funded by the EDCTP2, which aims to prequalify paediatric formulations, was initiated the IMPRIMA project to facilitate the integration of SLDPQ through the execution of a real-life implementation study utilizing flavoured primaquine specifically designed for paediatric populations (innovative formulation development through the DPP project). Central to our endeavour is the distinctive triad of interrelated activities—clinical, community/sociological, and policy—operating within a framework of capacity enhancement and robust coordination among all seven participating partners.
Our ambitious proposal seeks to validate the safety, acceptability, and communal advantages of SLDPQ across three African nations characterized by diverse malaria epidemiological profiles. Engagement with local communities and policymakers is critical to instigate favourable shifts in drug policy and to contribute to the overarching goal of malaria elimination. In parallel, capacity will be enhanced for conducting clinical trials and monitoring the evolution of antimalarial drugs resistance.

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 provisions phase of the IMPRIMA project focused on preparing actions for the exploration phase.

WP1 Coordination and Project Management: Governance structures (Consortium Executive and Steering Committees, and DSMB) were established, consortium agreements validated, and key meetings held (Kick-off in March 2023, consortium meeting in November 2023). Regular operational meetings, partner support, and quality control of deliverables were implemented.

WP2 Clinical Study Design: The quasi-experimental study was structured as an open cluster randomized trial to assess SLDPQ’s safety and acceptability. Preparations included site selection, protocol development, ethical approvals, data collection planning, and logistical management. The study is set to begin in Q1 2025.

WP3 Community-Based Intervention: This research used a social approach to understand malaria transmission and prevention within local contexts. A literature review guided protocol development, ethical approvals, staff training, and a baseline KAP study to identify barriers to clinical study implementation. Data analysis and reporting are expected by late 2024.

WP4 Training and Communication: Toolkits, public communication (website, social media), and scientific dissemination were developed. Trainings supported WP2 and WP3, targeting decision-makers, healthcare professionals, and communities.

WP5 Policy and Advocacy: Policy landscape assessments and stakeholder mapping (completed in Burundi, ongoing in other countries) informed an advocacy strategy and theory of change. A manuscript, ‘Single Low-Dose Primaquine for Malaria Control in Africa: Addressing Safety, Efficacy, and Policy Barriers,’ is being finalized for submission.

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)

The IMPRIMA project has achieved significant advancements beyond the current state of the art. Comprehensive clinical and social study protocols have been developed, ensuring robust methodologies to evaluate project impact. Survey data analysis has provided critical insights into community knowledge, attitudes, and practices (KAP) on malaria and public health interventions, enabling tailored and effective strategies. A detailed communication plan has been created to disseminate findings to both the scientific community and the public, fostering greater awareness and engagement. Finally, the mapping of key decision-makers and stakeholders in public health has facilitated targeted collaboration and advocacy, paving the way for improved policy integration and the sustainability of outcomes. Together, these achievements reflect IMPRIMA's innovative approach to integrating research, community engagement, and policy influence.