An interventional study of WASH kit and Standard treatment in Severe Acute Malnutrition, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Senegal. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Prevention
This study evaluates the addition of a simple, scalable "WASH kit", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.
Severe acute malnutrition (SAM) is defined as a weight-for-height z-score (WHZ) below -3 of the World Health Organisation growth standards. It is a short-term acute condition with a high case-fatality rate that increases both the susceptibility of children to infection and the risk of mortality. The global prevalence of SAM in children is estimated to be over 17 million with most of those affected living in sub-Saharan Africa and Asia.
Community-Based Management of Acute Malnutrition (CMAM) has significantly changed standard practice for the treatment of SAM. Uncomplicated SAM cases are now predominantly managed on an outpatient basis and Action Contre la Faim (ACF) supports outpatient treatment programs (OTP) across the globe, particularly in Africa and Asia. This innovation has increased coverage, and reduced the cost of treatment for both the health system and individuals. However, under CMAM, the treatment context has moved from a more controlled health facility setting to the generally less controlled household setting where the risk of infection due to environmental hazards, such as contaminated water, may be higher.
The TISA trial described here will evaluate the effectiveness of combining a simple, scalable "WASH kit" with OTP on the recovery rate among uncomplicated SAM cases aged 6-59 compared to the national standard OTP. The WASH kit includes a plastic container, a supply of Aquatabs® (effervescent chlorine tablets), and training in their use and associated hygiene practices. The study is a cluster randomized controlled trial (cRCT), with health centres constituting the clusters. Clusters are randomly allocated to either a control group receiving the standard OTP or an intervention group receiving OTP plus the WASH kit. The primary outcome of the trial is the recovery rate and the secondary outcomes are weight gain, referral rate, longitudinal prevalence of diarrhoea, prevalence of enteric pathogen detection and all-cause mortality.
82 studies on the registry are indexed under Severe Acute Malnutrition; 13 are open to participants now.
This study's enrollment of 2,411 is above the median of 400 across 69 interventional studies indexed under Severe Acute Malnutrition.
Browse Severe Acute Malnutrition studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In addition to the national standard outpatient treatment for uncomplicated severe acute malnutrition, caregivers of participants will receive a "WASH kit" containing a plastic container, a supply of Aquatabs® (effervescent chlorine tablets), and training in their use and associated hygiene practices.
Other: WASH kit
National standard outpatient treatment for uncomplicated severe acute malnutrition
Other: Standard treatment
WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.
National standard outpatient treatment for uncomplicated severe acute malnutrition
Rate of recovery
Recovery defined as two consecutive weeks with weight-for-height z-scores ≥ -1.5, if admitted based on weight-for-height z-score, or brachial perimeter (mid-upper arm circumference) ≥ 125 mm, if admitted based on brachial perimeter, and no oedema.
Time frame: 8 weeks
Weight gain
Weight gain defined as grams of weight gained per kilogram per day between entry and exit.
Time frame: 8 weeks
Rate of referral
Referral rate defined as number of participants referred/transferred to next level of care.
Time frame: 8 weeks
Longitudinal prevalence of diarrhoea
Longitudinal prevalence is defined by weeks with diarrhoea during follow-up with diarrhoea defined according to WHO definition (3 or more loose or liquid stools passed within 24 hours).
Time frame: 8 weeks
Prevalence of enteric pathogen detection
Enteric pathogen detection by stool-based molecular assays of following pathogens: Adenovirus F(40/41), Astrovirus, Norovirus GI, Norovirus GII, Rotavirus, Sapovirus, Enteroaggregative E. coli (EAEC), Shiga-like toxin producing E. coli (STEC), Enteropathogenic Escherichia coli (EPEC), Enterotoxigenic E. coli (ETEC), Shigella/ Enteroinvasive Escherichia coli (EIEC), Campylobacter jejuni/coli, Salmonella enterica, Salmonella enterica Typhi, Vibrio cholerae, Clostridioides difficile, Yersinia enterocolitica, E. coli O157, Aeromonas, Helicobacter pylori, Cryptosporidium spp., Giardia spp., Entamoeba histolytica, Ascaris lumbricoides, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercolaris, Plesiomonas shigelloides, Shigella flexneri, Shigella sonnei, Cyclospora cayetanensis.
Time frame: 8 weeks
All cause mortality
Deaths occurring during follow-up due to any cause.
Time frame: 8 weeks
Plan to share: Yes — All IPD that underlie results in a publication will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: December 2022
Access criteria: All IPD that underlie results will be made publicly available
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London School of Hygiene and Tropical Medicine →