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Article History

Received: 15 October 2020

Accepted: 5 January 2021

First Online: 21 January 2021

Ethics approval and consent to participate

: This trial has been approved by Ethikkomission der Nordwest und Zentralschweiz, Switzerland (EKNZ, reference number: 2019-00817), the Institutional review board of Ifakara Health Institute (reference number: IHI/IRB/No: 29 - 2019), the National Institute for Medical Research (reference number: NIMR/HQ/R.8a/Vol. IX/3277), the Tanzania Medicines and Medical Devices Authority (reference number: TMDA A0020/CTR/0002/03), and the National Health Research and Ethics Committee, Ministry of Health of Lesotho (reference number: 224 - 2019).The study investigator (or his/her designee) obtains written informed consent from all study participants before any study procedure and after explaining to the participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each participant is informed that participation in the study is voluntary, that he/she may withdraw from the study at any time, and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment. The participant is given a copy of the document, dated and signed by him and the investigator (or his designee); the original is retained as part of the study records. If the participant is illiterate, the study information is being read to him/her in the presence of a valid witness and the signature of a witness and the fingerprint of the participant is obtained. Study participants do not receive any payment to be part of the study besides compensation for transport expenses for additional clinical visits. Non-consenting participants are not included in the study.Locally, the results of this trial will be shared to the district officials during district management team meetings at the national research symposium of the Ministry of Health in both countries. Additionally, the results will be disseminated through international presentations at conferences and publication in peer-reviewed journals. We do not intend to use a professional medical writer.

: Consent is asked from study participants for publication of gathered study data without providing identifying information of the participant.

: All authors declare that they have no competing interests.