Ssewamala, Fred M.
Sauceda, John A.
Brathwaite, Rachel
Neilands, Torsten B.
Nabunya, Proscovia
Brown, Derek
Sensoy Bahar, Ozge
Namuwonge, Flavia
Nakasujja, Noeline
Mugarura, Allan
Mwebembezi, Abel
Nartey, Portia
Mukasa, Barbara
Gwadz, Marya
Article History
Received: 1 February 2023
Accepted: 29 March 2023
First Online: 20 April 2023
Declarations
:
: Written informed assent and consent will be obtained from the adolescent participant and their caregiver. To prevent any compulsion, the procedures for adolescents and adult caregivers will be separate. Forms for consent and assent will be translated into Luganda from English. Adolescent participants will speak English, although some may be more comfortable speaking Luganda. In light of the participants' English competence, the assent procedure will be conducted in either English or Luganda. The research outlined in this manuscript is being performed in accordance with the Declaration of Helsinki. All study procedures were approved by the Washington University in St. Louis Institutional Review Board (IRB) (202209102) on 09/27/2022 and by in-country local IRBs in Uganda: Uganda Virus Research Institute (UVRI) (GC/127/923) on 09/01/2022, and Uganda National Council of Science and Technology (UNCST) (SS1449ES) on 11/11/2022. The study is also establishing a Data and Safety Monitoring Board (DSMB). This DSMB is independent and charged with providing an initial review and ongoing annual review to monitor any protocol modifications, reporting of adverse events. Members of the Data and Safety Monitoring Board were invited and all members accepted to be a part of the study after reading the parameters of the study by December 21<sup>st</sup>, 2022. The first DSMB meeting was held on March 1<sup>st</sup>, 2023.
: Not applicable.
: The authors have no competing interest.