Griswold, Stacy P. http://orcid.org/0000-0001-7572-3316
Marshak, Anastasia
Fitzpatrick, Merry
Lantagne, Daniele
Shoenmakers, Kate
Hebie, Marlene
Radday, Anne
De Groote, Hugo
Mehta, Saurabh
Gottlieb, Greg
Webb, Patrick
Ghosh, Shibani
Funding for this research was provided by:
united states agency for international development (7200AA18CA00044)
Article History
Received: 12 July 2021
Accepted: 11 March 2022
First Online: 1 April 2022
Declarations
:
: All informed consent forms will be translated to Acholi using a certified translator. The informed consent form will consist of a brief description of the proposed work, risks and benefits to participation, privacy protection, and study personnel contact information. An enumeration team will be recruited and trained on the study’s consenting procedures. The participants will be informed that he or she may withdraw from the study at any time. Their relationship with research, intervention, or affiliated teams will not be influenced in any manner. The institutional review board of the Tufts University Health Science Committee will serve as the primary US-based review board and the Makerere University School of Public Health Higher Degrees, Research and Ethics Committee will serve as the primary review board in Uganda responsible for review and approval of the protocol and all amendments. The review boards of Cornell University and CIMMYT will also provide a review of the protocol.At the time of continuing/annual review, each participating site will submit completed self-audit tools to the Tufts PI, a summary of which will be submitted to the Tufts Health Sciences IRB at the time of continuing/annual review (summary of any issues identified during the self-audit). This summary will be described in the cover letter accompanying the continuing/annual review application. The original self-audit checklists will be available upon request from the Tufts Health Sciences IRB. As this is a community-based social behavior change intervention, this study does not screen for specific clinical conditions. The study does use MUAC and WHZ to assess nutritional status, and children identified as severely malnourished (SAM) will be referred to the local village health volunteer and to a facility with adequate care provisioning.
: Not applicable.
: The authors report that SM is an unpaid board member for a diagnostic start-up focused on the measurement of nutritional biomarkers at the point-of-care utilizing the results from his research in studies like this one. There are no other conflicts of interest.