Ethical considerations
The study has received approvals from the Mulago Hospital Research and Ethics Committee (Ref No: MHREC2125), the Uganda National Council for Science and Technology (Ref No: HS1796ES) and the National Drug Authority (RefNo:476/NDA/DPS/08/2021). The informed consent/assent document are in compliance with GCP and local regulatory authorities. Participants are taken through the consent process by the study team (Medical Officer or Study Nurse). Assent is requested from children between 8 and 17 years, and in addition, consent is sought from their parents or legally authorized representative. Informed consent is sought from participants aged 18 years and above and emancipated minors. Approval for protocol amendments shall be submitted to the Mulago Hospital Research and Ethics Committee for approval and then communicated to the National Drug Authority and The Uganda National Council for Science and Technology before implementation. Participants will be free to withdraw at any point of the study without any compromise to receiving their standard therapy. Children aged 8–17 years that do not provide assent but whose guardians have signed consent or vice versa will not be included in the study.