Status

Participant enrollment to the LAKANA trial started in November 2020 and will continue until 2023.

Progress in preparatory activities

Completed 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.

Ongoing activities:

• 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.

Upcoming activities:

• Training of local personnel.
• Piloting of SOPs and data collection forms.
• Piloting of the data collection system.