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Article History

Received: 20 August 2020

Accepted: 8 October 2020

First Online: 19 October 2020

Ethics approval and consent to participate

: This trial has been approved by the National Health Research Ethics Committee in Lesotho (ID229–2019), the Institutional Review Board of the Ifakara Health Institute (12–2020), the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol IX/3442), and the Tanzania Medicines and Medical Devices Authority (TMDA0020/CTR/0003/03). In addition, the Ethikkommission Nordwest- und Zentralschweiz in Switzerland provided a statement confirming the trial meets all requirements for a Swiss research project (Req-2019-01275).Written informed consent and, where applicable, written informed assent is a prerequisite for participation in this study. The consenting process is conducted by an authorised member of the study team based at the respective site. Before deciding whether or not to consent, participants/caregivers are given detailed information about the study, and are informed that they will continue to receive the standard of care if they choose not to participate and that they may withdraw their consent at any time. Participants aged ≥16 years (Lesotho) or ≥18 years (Tanzania) fill in an Informed Consent Form. For children and younger adolescents below these age thresholds, a caregiver fills in a separate Informed Consent Form for caregivers. Within the approved study protocol, a caregiver is defined as a parent, a legal guardian, or an adult aged ≥18 years and living in the same household as the participant. In addition, participants aged ≥12 and <16 years (Lesotho) or ≥12 and < 18 years (Tanzania) fill in an Informed Assent Form for Adolescents, and those aged ≥6 and <12 years fill in a simplified Informed Assent Form for Children. All forms are available in English as well as Sesotho (Lesotho) or Swahili (Tanzania). In the case of illiteracy, consent/assent is given by thumb print, and a witness signature is required.

: Not applicable.

: TK reports advisory board membership fees from ViiV and Gilead for work outside of this study. All other authors declare that they have no competing interests.