Joy, Edward J. M. http://orcid.org/0000-0002-0106-866X
Kalimbira, Alexander A.
Gashu, Dawd
Ferguson, Elaine L.
Sturgess, Joanna
Dangour, Alan D.
Banda, Leonard
Chiutsi-Phiri, Gabriella
Bailey, Elizabeth H.
Langley-Evans, Simon C.
Lark, R. Murray
Millar, Kate
Young, Scott D.
Matandika, Limbanazo
Mfutso-Bengo, Joseph
Phuka, John C.
Phiri, Felix P.
Gondwe, Jellita
Ander, E. Louise
Lowe, Nicola M.
Nalivata, Patson C.
Broadley, Martin R.
Allen, Elizabeth
Funding for this research was provided by:
Bill & Melinda Gates Foundation (OPP1181048, OPP1181048)
Article History
Received: 31 July 2019
Accepted: 8 November 2019
First Online: 30 December 2019
Ethics approval and consent to participate
: The trial is being conducted in accordance with the principles of Good Clinical Practice [CitationRef removed]. Ethical approval for the formative research was sought and obtained from the London School of Hygiene & Tropical Medicine Observational Research Ethics Committee (reference: 15730) and the Malawi College of Medicine Research Ethics Committee (reference: P.05/18/2393). The trial protocol and amendments have been approved by the London School of Hygiene & Tropical Medicine Interventions Research Ethics Committee (reference: 16181) and the Malawi College of Medicine Research Ethics Committee (reference: P.11/18/2539), and the trial is a registered clinical trial (March 2019; ISCRTN85899451).Participation in the study is voluntary. Trained RAs will seek written informed consent from WRA and assent from SAC in the presence of an adult caregiver prior to recruitment. Participants have the right to withdraw at any stage.The AHHA Malawi trial is overseen by a TSC with the following independent members: Professor Penelope Nestel (chair), Dr. Chrissie Thakwalakwa (Malawi nutrition expert) and Dr. Charles Opondo (statistician). The TSC is responsible for overseeing the safe and ethical conduct of the trial in accordance with the standards set out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice. The AHHA study is considered a low-risk trial because of the nature of the intervention. Furthermore, no interim data will be collected. Thus, there will not be a Data Monitoring Committee; instead, the independent statistician will advise on the continuation/discontinuation of the trial following safety reports from the PI.The Trial Management Group will discuss any potential protocol amendments with the TSC. If the TSC approves the amendment, then an application will be submitted to the RECs. Participant Information Sheets will be updated accordingly.
: Not applicable.
: The authors declare that they have no competing interests.