Chebet, Martin
Mukunya, David http://orcid.org/0000-0002-3892-9777
Burgoine, Kathy
Kühl, Melf-Jakob
Wang, Duolao
Medina-Lara, Antonieta
Faragher, Eric Brian
Odiit, Amos
Olupot-Olupot, Peter
Stadskleiv Engebretsen, Ingunn Marie
Waniaye, John Baptist
Wandabwa, Julius
Tylleskär, Thorkild
Weeks, Andrew
Funding for this research was provided by:
European and Developing Countries Clinical Trials Partnership (RIA2017MC-2029)
Article History
Received: 3 March 2023
Accepted: 12 April 2023
First Online: 17 April 2023
Declarations
:
: The study is conducted according to the principles of the Declaration of Helsinki and relevant regulations and with Good Clinical Practice. We obtain informed consent from the participants prior to enrolment (Appendices InternalRef removed and InternalRef removed). Ethical approval to conduct the study was obtained from the Research and Ethics Committee of the University of Liverpool (UoL004457), Regional Committee for Medical and Health Research Ethics (REC-vest), Norway (#47004), and Cure hospital Uganda <b>(</b>CCHU-REC/21/019). For all substantial amendments to the original approved documents, the chief investigator will submit and, where necessary, obtain approval from the above parties. All deviations from the original protocol are fully documented in a protocol deviation log. We also obtained administrative approval from the representative districts. At the time of submitting this paper, the protocol version was: version 5.0 24JUN2021. All documents are stored securely and only accessible by study staff and authorised personnel. The study will comply with the Ugandan Data Protection and Privacy Act (2019), the EU General Data Protection Regulation (GDPR), and Data Protection Act (2018), which require data to be de-identified as soon as it is practical to do so. There is no anticipated harm nor compensation for trial participation during and after the trial, although participants will receive payments for any study-related travel and for medication for themselves and their children up to 3 months postnatally.
: Not applicable.
: The authors declare that they have no competing interests.