An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM (Co-SAM)
Severe Acute Malnutrition, HIV, Comorbidities and Coexisting Conditions
About this trial
This is an interventional treatment trial for Severe Acute Malnutrition
Eligibility Criteria
Inclusion Criteria: Age 6-59 months, of either sex Hospitalised with complicated severe acute malnutrition, as per WHO definition Started transition to RUTF Caregiver willing and able to attend the study clinic for all visits Caregiver able and willing to give informed consent Exclusion Criteria: Any acute or chronic condition which mean that receipt of one or more study interventions, or participation in the trial, would not be advisable.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm 1: Standard-of-care (control)
Arm 2: Antimicrobial package
Arm 3: Reformulated RUTF
Arm 4: Psychosocial package
Arm 5: Antimicrobial package + reformulated RUTF + psychosocial package
Children in the control arm will receive Ready to Use Therapeutic Food (RUTF) for at least 2 weeks, plus all standard care. Children with HIV will receive long-term Cotrimoxazole prophylaxis and antiretroviral therapy, as per current guidelines.
Children will receive a bundle of azithromycin (3 days every month), isoniazid (daily), rifampicin (daily) and pyridoxine (daily) for 12 weeks.
Children will receive a reformulated RUTF, with increased medium-chain triglycerides (MCTs), higher hydrolysed protein content and a more bioavailable form of selenium (selenium yeast). Children will receive RUTF for at least 2 weeks.
Caregiver-child pairs will receive a low-cost, co-designed intervention to strengthen caregiver support, enhance income generation and promote child play. This is delivered over 12 weeks and comprises: i) The Friendship Bench, developed as a low-cost psychological intervention utilising problem-solving therapy (delivered by trained lay workers) and peer-to-peer support to address depression and other common mental disorders. ii) Care for Child Development is a UNICEF package that helps families build stronger relationships and solve problems in caring for the child at home, through play and communication activities in a series of age-appropriate interactive modules delivered by a lay worker using 'flash' cards. iii) Educational and behaviour-change messages around better nutrition; play for children with SAM; stigma, HIV and gender-based violence; financial planning; causes of SAM; and health-seeking behaviours.
A combination of all interventions from arms 2, 3 and 4, plus standard care delivered for 12 weeks.