Makaula, Peter https://orcid.org/0000-0002-1198-1655
Funsanani, Mathias
Mamba, Kondwani Chidzammbuyo
Musaya, Janelisa
Bloch, Paul
Funding for this research was provided by:
FP7 People: Marie-Curie Actions (AFRO/TDR/SGS/2016.1)
Article History
Received: 16 November 2018
Accepted: 11 July 2019
First Online: 22 July 2019
Ethics approval and consent to participate
: The study protocol, including the informed consent forms were reviewed and approved by both WHO Ethics Review Committee and Malawi’s National Health Sciences Research and Ethics Committee (NHSREC) (Approval # 628) prior to the commencement of the study. The study was retrospectively registered and approved by the Pan African Clinical Trial Registry: PACTR201903883154921. Community consent was obtained during the very first step in the CDI process when the proposed interventions were discussed with the whole community, and the community collectively agreed on the package for intervention. Informed consent was individually obtained from every study participant at the very beginning before proceeding with their involvement after being explained to clearly about the study objectives and aims using local languages of Chichewa and Chiyao used in the study areas. For participants who were literate, a written consent (see Additional file ) was obtained while for those not literate a verbal informed consent was obtained instead. Similarly for the study participants who were children (under 16 years of age), consent to participate was collected from their parents or guardians on their behalf. All the research instruments that were used at community level were also translated to local languages.
: Not applicable. The manuscript does not contain any individual person’s data in any form.
: The authors declare that they have no competing interests.