Happel, Anna-Ursula http://orcid.org/0000-0003-3658-8638
Singh, Ravesh
Mitchev, Nireshni
Mlisana, Koleka
Jaspan, Heather B.
Barnabas, Shaun L.
Passmore, Jo-Ann S.
Funding for this research was provided by:
Centre of Excellence in HIV Prevention
Poliomyelitis Research Foundation (n/a)
National Research Foundation (n/a)
University of Cape Town (n/a)
Article History
Received: 10 February 2020
Accepted: 29 June 2020
First Online: 10 July 2020
Ethics approval and consent to participate
: Approval for this clinical trial was obtained from University of Cape Town (UCT) Human Research Ethics Committee (HREC Ref 706/2016) and the South African National Health Research Ethics Council (NHREC Ref 4579). The trial was registered with the South African National Clinical Trial Register of the Department of Health (DOH-27-1117-5579; PI: S. Barnabas) and conducted in full compliance with South African Good Clinical Practice (SA-GCP) and International Conference on Harmonisation (ICH)-GCP, supported by the UCT Clinical Research Centre (CRC). Before undergoing any trial-related procedures, all women provided written informed consent.
: Not applicable.
: None of the authors reported any conflict of interest. We confirm that none of the manufacturers were involved in the design or testing of this product and did not contribute financially in any way towards the conduct of this study. In addition, we confirm that none of the authors involved in this study are associated in any way financially or otherwise with the manufacturers.