Masonbrink, Abbey R.
Hurley, Emily A.
Schuetz, Nikolaus
Rodean, Jonathan
Rupe, Emily
Lewis, Kemi
Boncoeur, Marie Daphnée
Miller, Melissa K.
Funding for this research was provided by:
Organon BioSciences
National Institutes of Health
Article History
Received: 6 September 2022
Accepted: 8 March 2023
First Online: 27 March 2023
Declarations
:
: All methods were carried out in accordance with relevant guidelines and regulations in the Declaration of Helsinki. The study was reviewed (including study protocol, all study documents and verbal informed consent process) was approved by the institutional review board at the affiliated academic institution, Children’s Mercy Hospital, Kansas City, MO, in the United States and by a local organization or community representative (Global Birthing Home Foundation and Hospital Albert Schweitzer) according to local procedures in Haiti. Eligible AYAs were approached at their homes and underwent verbal informed assent (15–17 years old) or verbal informed consent (18–24 years old) for study enrollment. This study was deemed no greater than minimal risk by the IRB and ethical review and so according to regulatory code 45 CFR 46.408 and similar to other studies in adolescents in Haiti, [7, 20] parental consent was waived; however if a parent or guardian was present they were given brief study information and then asked to provide a private space for assent or consent and study procedures. We obtained verbal consent to protect participant confidentiality and minimize collection of study materials with any personal identification information, which was approved after ethical review of the study by the Institutional Review Board in the US and by the local organizations listed above.
: Not applicable.
: The authors have no conflicts of interest to report and have no additional financial relationships related to this article to disclose.