ASAAP is structured into 8 work packages covering five projects articulated around this multicentre clinical trial.
WP1: Management & Coordination
The WP1 deals with the overall management of the ASAAP project. WP1 is responsible of the implementation of the grant agreement and the consortium agreement. WP1 takes care of the direct communication with EDCTP and the administrative and financial issues. It supervises the implementation of the project activities and ensures that progress is made on time and according to the budget. The WP1 is also responsible for the ethical and safety management of the project, therefore it interacts closely with all the work packages.
WP2: Clinical Trial
WP2 activities include the preparation phase and the monitoring of the implementation of the mono-centre preparatory pilot-study project in Gabon (Study I), of the randomized placebo-controlled main multi-centre clinical trial conducted in Benin, Gabon, Ghana, and Mali (Study II), and of the clinical part of the multi-centre pharmacokinetic study (Study III). This includes the development of clinical documents and SOPs. WP2 will supervise the harmonization of each clinical site and will train the local staff in GCP and GCLP. WP2 is responsible for the adverse events reporting system, will interact with WP1 for the management of severe adverse event cases, will interact with WP3 and WP5 for dealing with the sample and data collection, respectively, and with WP6 for the harmonization and capacity development of the trial sites.
WP3: Laboratory Analysis
WP3 activities deal with the management of the sample collection, processing, and analysis (except clinical blood and biochemistry measures, WP2). This includes the development of a laboratory operating manual (QC/QA and SOPs). WP3 is responsible for the determination of re-infection and recrudescence cases by PCR correction and of the dynamics of gametocytemia by real-time quantitative PCR in patients receiving AL+AP or Artemether-Lumefantrine (AL) in the clinical trial (in support of efficacy analyses of Studies II and IV), and for the pharmacokinetic data on AL and AL+AP (Study III). Finally, WP3 will test, as an exploratory study, whether AL+AP and AL exert differential selection of antimalarial resistance markers in African parasites, especially AP resistance (Study V). The WP3 research activities are nested into the WP2, as it requires sampling from the clinical trial patients. WP3 will interact with WP5 for data management and analysis and with WP4 for organizing the shipment of samples for entomology assays in Bobo Dioulasso.
WP4: Entomology
WP4 aims to determine the efficacy of AL+AP in preventing human-to-mosquito transmission of P. falciparum and preventing the development of mosquito stage of P. falciparum (Study IV). The first part of its activities (blocking transmission from human-to-mosquitoes) will be realized at the clinical site level in Benin, Gabon, Ghana, and Mali. WP4 is responsible for the training of local entomologists on membrane feeding assays and will monitor the implementation of the assays locally. This includes the development of SOPs. WP4 will supervise the upgrade of local insectarium in Ghana, Mali, Gabon and Benin to level 2. The second part of the Study IV will be done in Bobo Dioulasso, Burkina Faso by IRSS. As an exploratory study it will measure the effect of serum from patients treated with AL+AP, and administered in second blood meals to P. falciparum-infected mosquitoes, on ookinete/oocyst infection. The WP4 research activities are nested into the WP2, as it requires sampling from the clinical trial patients. WP4 will interact with WP5 for the data management and analysis.
WP5: Data Management & Analysis
WP5 is responsible for data management according to GCP procedure and for data analysis. WP5 will develop and implement a data management plan and data analysis plan, deal with the establishment of the safety database, and be responsible for the data analysis components of the five projects. WP5 will interact with WP2, WP3 and WP4 for data management and data analysis and with WP7 for the data sharing plan.
WP6: Capacity Building
WP6 concerns capacity developments of the African study sites. WP6 will supervise the harmonization of the site by identifying the gaps and allocating the resources to mitigate. This goes hand-in-hand with upgrading of infrastructure and equipment. WP6 deals with the organization of short trainings in GCP, data management, entomology and laboratory analysis and with long-term degree (work-oriented) training (MSc and PhD level) by putting in place a mentorship program. Training in soft skills like paper and grant writing will be offered. WP6 will interact with WP2, WP3, WP4 and WP5 and will facilitate the short-term trainings and provide supervision for the MSc and PhD researchers.
WP7: Networking & Dissemination
WP7 aims to strengthen existing relationships and to foster new ones among scientists and institutions in order to generate new research ideas, and increase eligibility for grant applications and likelihood of success. WP7 will create an environment that provides mutual support across the study sites and among study partners and provides consistent visibility to the study both nationally and internationally. Finally, WP7 facilitates the contribution of the study to knowledge about antimalarial therapy that informs antimalarial treatment policy and outcomes. WP7 interacts with all the WPs to increase their visibility by promoting their progress.
WP8: Coordination (ASAAP Plus)
WP8 addresses the executive tasks of the project by overseeing the implementation of the project activities and their achievement in a timely manner and within the budget allocated. ASAAP Plus Project under EDCTP3 is coordinated by BNITM and the Scientific Project Leadership is held at KCCR/KNUST
