Datta, Dibyadyuti
Namazzi, Ruth
Conroy, Andrea L.
Cusick, Sarah E.
Hume, Heather A.
Tagoola, Abner
Ware, Russell E.
Opoka, Robert O.
John, Chandy C. https://orcid.org/0000-0002-1634-1411
Funding for this research was provided by:
Thrasher Research Fund (14221)
Article History
Received: 1 February 2019
Accepted: 10 July 2019
First Online: 26 July 2019
Ethics approval and consent to participate
: The Makerere University School of Medicine Research Ethics Committee (SOMREC, # 2018–066), the Jinja Hospital Research and Ethics Committee (JREC), the Ugandan National Drug Authority (NDA, CTA0071) and the Uganda National Council for Science and Technology (UNCST, HS2416), together with Indiana University Institutional Review Board (IU IRB, # 1712339562) have reviewed and approved the study protocol.Written informed consent will be obtained from the parent or guardian of subjects since they are below the legal age for consent or assent. The consent has been translated into local languages (Luganda, Lusoga). Illiteracy is common in the study area requiring adaptation of the consent process. For those who cannot read and write, an independent witness will be present during the informed consent process and will sign the consent form as a witness. The parent or guardian will provide a thumbprint to the consent form.Study participants will be managed at the Jinja Regional Referral Hospital according to national guidelines and local clinical practices, including routine infection prophylaxis and hydroxyurea therapy for severe clinical complications such as stroke.
: Results from this study will be presented in publications and meetings, but will not contain any identifying information. Consent for publication as well as sample storage for future research will be obtained from participants in the study. There is no limit on the length of time samples will be stored for future use and there is no stipulation requiring results of future research be communicated to participants.
: The authors declare that they have no competing interests.