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1. Key Information conveyed during informed consent process
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| Q1. This is research study is being done to learn more about the treatment of malaria. We are carrying out a research study to compare different medicines for the treatment of mild malaria (Malactres Patient Information Sheet). |
| Q2. With this study we want to find out their efficacy and safety and also see if he parasite is resistant to them (Malactres Patient Information Sheet). |
| Q3. The study medicine that your child will receive will be determined by a process of randomization. Randomization means that your child will receive by a study nurse one of the 2 medicines studied by chance (Malactres Patient Information Sheet). |
| Q4. Your child’s participation in this study is completely voluntary. If you decide that you do not want to participate in the study or decide to withdraw your child from the study at any time and for any reason, this will not affect your child’s care at the outpatient department, where standard care for all medical problems is available. During the study, you will be informed promptly of any new information that may influence your willingness to continue participation in the study. |
| Q5. Should you decide to withdraw your child from the study before your child has finished the course of study medicines, then your child will receive the local standard treatment for malaria from the study team, but after the standard treatment has been given, medical care will no longer be provided by the study team. If the child is withdrawn from the study after completion of the course of study medicines, then no further care will be provided by the study team (Malactres Patient Information Sheet). |
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2. Research as Aid
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| Q6. People know we are poor, so they help us’ [Interview participating mother] |
| Q7. The doctors know that we do not have the money to treat our children so they treat them free of charge’. [Interview participating mother] |
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3. REPORTED REASONS FOR TRIAL PARTICIPATION
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| Q8. The doctors of the Centre Muraz take the child’s blood and check if he really has malaria while the others only ask what is wrong with the child’ [Informal conversation with participating mother]. |
| Q9. When the other doctors give my children medication, two days later the disease starts again. That’s why I wanted the team of Muraz to treat him” [Informal conversation with participating mother]. |
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4. Strategies for trial enrolment
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| Q10. When I got to the health centre, I didn’t know I shouldn’t have told the doctors that I had already given some medication to my child. Had I known that they refused to enrol my child for that I would never have told them” [Interview with mother of a non-recruited child]. |
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5. Perception of the trial in The community
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| Q11. I had received information on the work from women who came from the health centre with their children. They told me that someone was treating children free-of-charge’ [FGD. Mother of a non-recruited child] |
| Q12. I heard women say that there were people at the health centre who treat children free-of-charge, so I went’ [Informal conversation with mothers of recruited children]. |
