Document is current
Any future updates will be listed below
-
Authors
Plagianos, Marlena
Lansiaux, Maud
Kumar, Narender
Graham, Shelli
Sussman, Heather
Kushner, Harvey
Creasy, George
Bernick, Brian
Haddad, Lisa B.
- License Information
-
More Information
Article History
Received: 12 November 2024
Accepted: 16 November 2025
First Online: 26 November 2025
Declarations
:
: The study protocol was approved by the Institutional Review Boards of the Population Council and the study sites. The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and consistent with the International Conference on Harmonization, Good Clinical Practice guidelines, and applicable regulatory requirements. Written informed consent was obtained from all individuals to participate in the study.
: Informed consent was not obtained for data sharing, however shared data are fully de-identified, including removal of participant-related event dates.
: Several of the authors (Plagianos, Kumar, Sussman and Haddad) are current employees of the Population Council, which developed Annovera, but does not currently produce or market the product. To the best of our knowledge, no other competing interests exist.
