Funding for this research was provided by:
Office of U.S. Foreign Disaster Assistance (720FDA19GR00278)
Received: 17 August 2022
Accepted: 2 November 2022
First Online: 26 November 2022
: This study protocol was approved by the following ethical approval bodies: Solutions IRB, Yarnell, Arizona, US (March 2020, Reference: #20200310); London School of Hygiene and Tropical Medicine, Research Ethics Committee, London, UK (July 2020, Reference: 18059); Ministry of Health and Human Services, Kahda District Mogadishu, Somalia (March 2020, Reference: MOH&HS/DGO/0429/03/202); Universite Des Sciences, Des Techniques Et Des Technologies De Bamako, Bamako, Mali (Oct 2020, Reference: 2020/202/CE/FMOS/FAPH); and Ministry of Health, Juba, South Sudan. (June 2020, Reference: MOH/ERB 6/2020).The costing sub-study did not collect individual data from participants, but instead used institutional-level accounting data and interviews with program staff (MoH and ACF) regarding their time allocation and material costs related to the CMAM activities. Therefore consent for the costing study was not obtained. For the overarching SAM Relapse study, written consent was obtained as follows. On the day of enrollment, participants are informed about the duration and requirements of participation in the study along with the potential harms and benefits of participation through an interactive oral presentation and through written consent forms. Caregivers are repeatedly told that participation is voluntary, and they can stop study participation at any time without consequences for the care they might receive. Only participants who express continued interest in the study after being fully informed are enrolled. As study participants are under 16 years old, consent forms are signed and dated by the responsible caregiver for the participating child. In the case of illiterate participants, a participant draws a cross in replacement of a signature. If study participants withdraw from the study after enrollment, any data already collected and analyzed will be used, unless the participant requests otherwise; however, no further analysis will be done, nor samples kept. All electronic data will be stored on a study-specific password-protected encrypted server and located within a protected network to enable safe access. All patient files and data collection forms will be maintained securely in a locked file throughout the study to ensure participant confidentiality. The study is conducted in accordance with ICH-GCP E6 guidelines.
: Not applicable
: The authors declare that they have no competing interests.