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Authors
Benade, Mariet https://orcid.org/0000-0001-9498-3199
Maskew, Mhairi https://orcid.org/0000-0003-4238-0200
Ntjikelane, Vinolia https://orcid.org/0009-0003-2805-6890
Scott, Nancy https://orcid.org/0000-0002-4713-4642
Ngcobo, Nkosinathi
Nichols, Brooke https://orcid.org/0000-0003-4682-4999
Malala, Lufuno https://orcid.org/0009-0001-7695-3671
Manganye, Musa https://orcid.org/0000-0001-8420-0613
Rosen, Sydney https://orcid.org/0000-0002-6560-2964
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Funding
Funding for this research was provided by:
Bill and Melinda Gates Foundation (INV-031690, INV-031690, INV-031690, INV-031690, INV-031690, INV-031690, INV-031690)
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Article History
Received: 12 December 2024
Accepted: 7 July 2025
First Online: 26 July 2025
Declarations
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: The study protocol was reviewed and approved by the Human Research Ethics Committee of the University of Witwatersrand (M220440) and the Boston University IRB (H-42726) and by relevant Provincial Health Research Committees through the National Health Research Database in South Africa (KwaZulu-Natal: KZ_202207_014, Mpumalanga: MP_202207_004, Gauteng: GP_202207_049). The protocol is also registered on clinicaltrials.gov (NCT05454839). All participants provided written informed consent for all data collection. Tissue sample assays were performed in accordance with relevant guidelines and regulations. All study procedures complied in full with the Declaration of Helsinki.
: Not applicable.
: LM and MM are employees of the government agency that supervises the study sites. The authors declare that they have no other competing interests.
