Participant enrollment to the LAKANA trial started in November 2020 and will continue until 2023.
Progress in preparatory activities
- The study protocol has been completed.
- The trial plan has been approved by an institutional review board (IRB) in Mali and endorsed by an ethics committee in Finland.
- Approval has been obtained from Mali Ministry of Health.
- The data and safety monitoring board (DSMB) has reviewed and approved the safety monitoring plan.
- Study drugs have been manufactured and imported to Mali.
- External monitoring company has been contracted.
- The first drafts of the data collection forms have been developed.
- Standard operating procedures are being developed.
- The data collection system is being developed.
- We are making plans for starting the trial with the local communties in Mali.
- Training of local personnel.
- Piloting of SOPs and data collection forms.
- Piloting of the data collection system.