Brito, Atanásio
Korn, Abigail http://orcid.org/0000-0003-4641-2986
Monteiro, Leonel
Mudender, Florindo
Maiela, Adelina
Come, Jotamo
Barnhart, Scott
Feldacker, Caryl
Funding for this research was provided by:
Health Resources and Services Administration (U91HA06801)
Article History
Received: 7 November 2018
Accepted: 2 October 2019
First Online: 21 November 2019
Ethics approval and consent to participate
: This routine program activity received a Non-Research Determination under the University of Washington, which applies the definitions in the federal Common Rule (45 CFR 46 Subpart A). In addition, it was approved by two national Mozambican regulatory bodies: the Mozambique Institutional Review Board (<i>Comité Nacional de Bioética para Saúde</i> (approval # 05/CNBS/18)) and the Ministry of Health’s National Directorate of Medical Assistance “<i>Direcção Nacional de Assistência Médica” (DNAM)</i>, which provided administrative authorization for the activities in its role overseeing the VMMC program<i>.</i> As non-human subjects research, informed consent was deemed unnecessary, as per the federal Common Rule and Mozambican regulatory authorities.
: N/A. No individual person’s data are presented in this manuscript.
: The authors declare that they have no competing interests.