Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

To assess the prevalence of SARS-CoV-2 antibodies in the residents of Kibera informal settlement in Nairobi, Kenya, before vaccination became widespread, and explore demographic and health-related risk factors for infection.

A cross-sectional study.

Kibera informal settlement, Nairobi, Kenya.

Residents of Kibera informal settlement between October 2019 and August 2021, age 1 year and above who reported no current symptoms of COVID-19.

Associations were determined between SARS-CoV-2 positive tests measured with one rapid test and two ELISAs and demographic and health-related factors, using Pearson’s ² test. Crude OR and adjusted OR were calculated to quantify the strength of associations between variables and seropositive status.

A total of 438 participants were recruited. Most (79.2%) were age 18–50 years; females (64.2%) exceeded males. More than one-third (39.1%) were unemployed; only 7.4% were in formal, full-time employment. Less than one-quarter (22.1%) self-reported any underlying health conditions. Nearly two-thirds (64.2%) reported symptoms compatible with COVID-19 in the previous 16 months; only one (0.23%) had been hospitalised with a reported negative COVID-19 test. 370 (84.5%) participants tested positive in any of the three tests. There was no significant difference in SARS-CoV-2 seropositivity across age, sex, presence of underlying health conditions, on medication or those ever tested for SARS-CoV-2. Multiple logistic regression analysis showed that COVID-19 symptoms in the previous 16 months were the only significant independent predictor of seropositivity (p=0.0085).

High SARS-CoV-2 exposure with limited morbidity was found in the residents of Kibera informal settlement. The study confirms other reports of high SARS-CoV-2 exposure with limited morbidity in slum communities. Reasons cited include the high infectious disease burden on the African continent, demographic age structure and underreporting due to limited testing and lack of access to healthcare services; genetic factors may also play a role. These factors require further investigation.