Medina-Marino, Andrew http://orcid.org/0000-0002-0095-4141
Cleary, Susan
Muzny, Christina A.
Taylor, Christopher
Tamhane, Ashutosh
Ngwepe, Phuti
Bezuidenhout, Charl
Facente, Shelley N.
Mlisana, Koleka
Peters, Remco P. H.
Klausner, Jeffrey D.
Funding for this research was provided by:
National Institute of Allergy and Infectious Diseases (R01AI149339, R01AI149339)
Article History
Received: 18 November 2021
Accepted: 12 May 2022
First Online: 24 May 2022
Declarations
:
: This protocol and the informed consent forms have been reviewed and approved by the University of Cape Town, Research Ethics Committee (Approval Number: 676/2019) with respect to scientific content and compliance with applicable research and human subjects’ regulations. IRB approvals have also been granted by University of Southern California, University of Pennsylvania, University of Alabama, and Louisiana State University via IRB reliance on the University of Cape Town. Eastern Cape Provincial Department of Health approval (Approval Number: EC_202010_017) has been obtained to conduct this study in Buffalo City Metropolitan Health District. All participants will be required to provide written informed consent prior to being enrolled in the study. The protocol, informed consent form and all translations, participant education and recruitment materials, and amendments thereof were or will be reviewed and approved by the ethical review bodies responsible for oversight of research. Written informed consent to participant will be obtained from all participants. Subsequent to initial review and approval, the responsible Ethics Committees will review the protocol for renewal once every 12 months. The Investigators will submit safety and progress reports to the Ethics Committees at least annually, and within 3 months of study termination or completion. These reports will include the total number of participants enrolled in the study, the number of participants who completed the study, all changes in the research activity, and all unanticipated problems involving risks to human subjects or others.
: Not applicable.
: Co-author CAM is part of the Cepheid speakers’ bureau for topics regarding vaginal infections and sexually transmitted infections. She is also a consultant for the Centers for Diseases Control and Prevention, Lupin Pharmaceuticals, Abbott Molecular, BioMed Diagnostics, Cepheid, and PhagoMed. She has received research funding support from Lupin Pharmaceuticals, Gilead, and Abbott Molecular and speaker honoraria from Abbott Molecular, Cepheid, Roche Diagnostics, and Becton Dickinson. Co-author JDK has, in the past 12 months, received consulting fees from Abbott, Cepheid, Curative, Danaher, Roche, Talis Bio, and Visby Medical. The other authors declare no competing interests.