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Article History

Received: 14 January 2023

Accepted: 23 January 2024

First Online: 10 February 2024

Declarations

:

: The research protocol was approved on August 18th, 2022 by the National Ethics Committee of República de Angola Ministério da Saúde, reference number 27 C.E/MINSA.INIS/2022, and all methods are performed in accordance with the Helsinki Declaration. The trial was registered in clinical trials in October 7th 2022, NCT05571280. In order for the selected communities to participate in the study, the local authorities had to give written informed consent. Informative sessions were held with local authorities of communities selected in order to seek for their signed consent. Before recruitment, informed consent is also sought from individual participants. Field teams inform of the project and the specific intervention allocated to the cluster they belong to before asking for consent. Pregnant women’s informed consent will be obtained for their own participation and for their potential newborn children’s. Women are informed that participation in the study is voluntary and that they can drop out at any time without giving explanations. Confidentiality is guaranteed during the study, as participants will receive a study code that will not allow their identification.

: Not applicable.

: Monitors will conduct regular monitoring visits, during which they will inspect and verify the source data of Informed Consent Forms, medical records, laboratory results, and protocol deviations. Monitoring visits will be made periodically by VHIR representatives or designated monitors to ensure compliance with Good Clinical Practice (GCP) and all aspects of the protocol. Source documents will be reviewed for consistency with data in the electronic Case Report Forms (CRFs) and any data clarification forms/consultations.

: The authors declare no competing interests.