Document is current

Article History

Received: 11 February 2021

Accepted: 24 September 2021

First Online: 8 November 2021

Declarations

:

: All procedures performed in the MTN-020/ASPIRE study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All study participants consented to trial participation per site-specific informed consent forms modified from sample informed consent forms included in the ExternalRef removed, which is available at ExternalRef removed. The study was approved by the following Institutional Review Boards/Ethics Committees and Drug Regulatory Authorities: Prevention Sciences Research Committee of the US National Institute of Allergy and Infectious Diseases; US Food and Drug Administration; National Health Sciences Research Committee of Malawi; Johns Hopkins University Bloomberg School of Public Health Institutional Review Board; University of North Carolina at Chapel Hill Institutional Review Board; Pharmacy, Medicines and Poisons Board of Malawi; University of Cape Town: Human Research Ethics Committee; Biomedical Research Ethics Committee University of KwaZulu-Natal; South African Medical Research Council Ethics Committee; Human Research Ethics Committee: (Medical), University of Witwatersrand, Johannesburg; Medicines Control Council of South Africa; Joint Clinical Research Centre Institutional Review Board; Uganda National Council for Science and Technology; Johns Hopkins University School of Medicine Institutional Review Board; National Drug Authority of Uganda; Medical Research Council of Zimbabwe; Committee on Human Research, University of California - San Francisco; Joint Parirenyatwa Hospital and College of Health Sciences Research Ethics; Research Council of Zimbabwe; Medicines Control Authority of Zimbabwe.

: Not applicable.

: The authors declare that they have no competing interests.