Implementing Primaquine Single Low Dose in Africa

Informazioni relative al progetto

IMPRIMA

ID dell’accordo di sovvenzione: 101103213

DOI

10.3030/101103213

Data della firma CE 21 Marzo 2023

Data di avvio 1 Aprile 2023

Data di completamento 31 Marzo 2027

Finanziato da

• Health

Costo totale

€ 3 969 906,25

Contributo UE

€ 3 967 406,25

Coordinato da

UNIVERSITE DE STRASBOURG
France

Periodic Reporting for period 2 - IMPRIMA (Implementing Primaquine Single Low Dose in Africa)

Periodo di rendicontazione: 2024-10-01 al 2026-03-31

Sintesi del contesto e degli obiettivi generali del progetto

In the World Malaria Report 2025, clinical malaria cases climbed to 282 million with 610,000 deaths, an increase from 2019. To reduce transmission, the WHO recommended in 2012 the addition of single low-dose primaquine (SLDPQ) to artemisinin-based combination therapies, particularly in low transmission settings and, more recently, where artemisinin partial resistance is emerging. SLDPQ eradicates mature gametocytes, interrupting transmission between humans and mosquitoes, but its uptake has been limited by the lack of child-friendly formulations of primaquine and by concerns about acute haemolysis in individuals with G6PD deficiency. Building on the 'Developing Paediatric Primaquine' (DPP) project funded by EDCTP2, IMPRIMA was initiated to facilitate the integration of SLDPQ through a real-life implementation study using flavoured primaquine designed for children. Central to the project is a triad of interrelated activities - clinical, community/sociological, and policy - within a framework of capacity building and coordination among the seven partners. IMPRIMA aims to validate the safety, acceptability and community benefits of SLDPQ in three African countries with different malaria epidemiologies, engaging communities and policymakers to shift drug policy while enhancing capacities for clinical trials and resistance surveillance.

During the second reporting period, the project delivered its first results, addressing the needs it was designed to tackle. The lack of locally generated evidence on SLDPQ, the main barrier to its adoption in national policies, is now directly addressed: the pre-intervention prevalence survey was completed in the three countries (1,987 children), providing baseline transmission and drug-resistance data, and the implementation clinical trial started in October 2025 in Burkina Faso, Burundi and Madagascar, with more than 1,300 participants enrolled by March 2026 using the new paediatric formulations. The baseline qualitative study (94 interviews, 36 focus group discussions) documented community perceptions and barriers and now informs the community-based intervention. Local research capacity was strengthened by training site teams in Good Clinical Practice - including the first clinical trial ever conducted in Burundi - and through South-South and North-South exchanges. Finally, country-specific advocacy strategies and a policy dialogue with the three National Malaria Control Programmes strengthened the research-to-policy pathway, in a context made favourable by the confirmation of artemisinin partial resistance in Africa. Together, these results lay the evidence, community, capacity and policy foundations required for the adoption of SLDPQ into national malaria programmes.

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

The second phase of the IMPRIMA project focused on closing the preparation phase and launching the exploration phase.

WP1 Coordination and Project Management: Governance structures (Consortium Executive and Steering Committees, and Drug & Safety Monitoring Board) were established, legal and regulatory agreements validated, and key meetings were held (Meetings with GH EDCTP3 JU Project and Financial Officers, regular meetings of the Executive team and of the consortium with the project's Steering Committee). Regular operational meetings for each Work package were held, with a focus on WP2 and WP3 to launch the studies on the field. Harmonisation and quality control of deliverables was maintained and support was proposed to partners concerning administrative and financial management.

WP2 Clinical study: The intervention study at each site was preceded by a baseline community survey, conducted on a subset of children under five years old during the malaria transmission period.The samples collected in this prevalence survey are currently being analysed. Site initiation visits were conducted at the different clinical sites as soon as the study drug was received. The enrolment of participants started at selected local health facilities in all three countries in October 2025 and is still ongoing. Patients attend the clinic as per usual, where they are seen and assessed by health and study staff. If they give their consent and are eligible, the participants are enrolled and monitored. Data are collected on paper and entered into the database at the earliest. Blood smears are read locally at each research laboratory. Other blood samples are being stored and to be sent to the central laboratory for later assessment.

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 were completed in Q3 2025. Building on these findings, the final period will focus on implementing the KAP study, alongside the consolidation and transfer of knowledge to support effective implementation.

WP4 Capacity building: scientific and clinical trainings were provided to support WP2 and WP3, including Good Manufacturing Practices, Good Clinical Practice and study procedures during the site initiation visits, targeting healthcare professionals and site teams in the three countries. Laboratory training in molecular analysis was provided through South-South and North-South exchanges, and early-career researchers were supported in scientific writing and oral presentation, contributing to two peer-reviewed publications during the period. Communication and dissemination activities are reported in the dedicated section of the continuous reporting.

WP5 Policy and legal Advocacy: Stakeholder mapping was refined and revised; advocacy strategies were developed for each IMPRIMA country site; relationships with key stakeholder were consolidated and coalition-building continued with IMPRIMA Committees (with key decision-makers) set up in Burundi and Burkina Faso. A monitoring and evaluation framework was developed and piloted with each of the IMPRIMA partners.

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)

During this reporting period, clinical studies were successfully launched across Madagascar, Burundi and Burkina Faso, representing a solid start to generating locally produced evidence on the safety, tolerability, acceptability and feasibility of SLDPQ in real-world settings. Community-based studies identified both opportunities and barriers to implementation, while stakeholder engagement, policy analysis, advocacy workshops and pilotage committees strengthened relationships between researchers, policymakers and National Malaria Control Programmes, creating a more favourable environment for future policy uptake.
The project has also strengthened research and implementation capacities through training in clinical trials, Good Clinical Practice, molecular surveillance and policy engagement, while expanding communication and dissemination activities to improve awareness and stakeholder engagement. Looking ahead, IMPRIMA is well positioned to support the integration of SLDPQ into national malaria treatment guidelines by providing robust clinical, social and implementation evidence, alongside practical advocacy tools, monitoring frameworks and implementation strategies. Beyond malaria, the project is developing a transferable model for translating research into policy and practice, contributing to stronger health systems, evidence-informed decision-making and sustainable research partnerships across sub-Saharan Africa.