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Article History

Accepted: 6 March 2025

First Online: 28 March 2025

Declarations

:

: Open access funding provided by Stellenbosch University. Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) was provided by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health, all components of the National Institutes of Health, under award numbers UM1AI068632 (IMPAACT LOC), UM1AI068616 (IMPAACT SDMC), and UM1AI106716 (IMPAACT LC), and by NICHD contract number HHSN275201800001I. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The University of Cape Town Clinical PK Laboratory has been granted funding as an International Pharmacology Specialty Laboratory by the IMPAACT network.

: The authors have no conflicts of interest to declare.

: Ethics review board approvals for the IMPAACT P1026s study were received from the Stellenbosch University Health Research Ethics Committee (N13/02/025_DTTC; 24 November 2016) and the University of the Witwatersrand Human Research Ethics Committee: Medical (160913; 24 March 2017). This study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

: All pregnant participants provided written informed consent for themselves and their infants to take part in this study.

: Not applicable (data are presented in aggregate and no personally identifiable information has been included in this manuscript).

: AS, BMB, MM, and DES contributed to the conceptualisation of the study and study design. RB, KG and NC contributed to the study implementation and oversight. PDK, LW, JSN, and LF contributed to the study implementation, data collection, and sample processing at the highest enrolling study sites. JH and ACE contributed to the literature search for the manuscript. KK contributed to the data extraction. JH, MP, KMB, DES, and MvS contributed to the data analysis. JH, ACE, ACH, and ED contributed to the writing of the manuscript. All authors contributed to reviewing the manuscript, and all authors have read and approved the final version.

: The data that support the findings of this study cannot be made publicly available because of the ethical restrictions in the study’s informed consent documents and in the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network’s approved human subjects protection plan; public availability may compromise participant confidentiality. However, data are available to all interested researchers upon reasonable request to the IMPAACT Statistical and Data Management Center’s data access committee (email: sdac.data@fstrf.org) with the agreement of the IMPAACT Network.