The TISA Trial - Senegal (TISA)

TISA (Traitement Intégré de la Sous-Nutrition Aiguë) Trial : A Cluster Randomized Controlled Trial for the Effect of a WASH Kit Combined With Standard Outpatient Treatment on Severe Acute Malnutrition Recovery in Senegal

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Malnutrition
• Intervention / Treatment: Other: WASH kit; Other: Standard treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2411
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Gallandat, PhD; Phone Number: 00442076368636; Email: karin.gallandat@lshtm.ac.uk
• Study Contact Backup: Name: Finou Thérèse Mendy, MSc; Phone Number: +221773291172; Email: fmendy@sn.acfspain.org

Study Locations

• Senegal
  • Louga, Senegal
    • ACF Senegal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Weight-for-height z-score <-3; or
• Brachial perimeter (mid-upper arm circumference) <115; or
• Bilateral oedema

Exclusion Criteria:

• Not able and/or willing to participate for up to 8-weeks
• Clinical complications requiring referral and/or inpatient treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.
Active Comparator: Control; National standard outpatient treatment for uncomplicated severe acute malnutrition	Other: Standard treatment; National standard outpatient treatment for uncomplicated severe acute malnutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain	Weight gain defined as grams of weight gained per kilogram per day between entry and exit.	8 weeks
Rate of referral	Referral rate defined as number of participants referred/transferred to next level of care.	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).	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.	8 weeks
All cause mortality	Deaths occurring during follow-up due to any cause.	8 weeks

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Cheikh Anta Diop University, Senegal; Action Contre la Faim
• Investigators: Principal Investigator: Dieynaba N'Diaye, PhD, Action Contre La Faim - France; Principal Investigator: Moustapha Seye, PhD, Université Cheikh Anta Diop de Dakar; Principal Investigator: Oliver Cumming, MSc, London School of Hygiene and Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: 2019-KEP-267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be shared
• IPD Sharing Time Frame: December 2022
• IPD Sharing Access Criteria: All IPD that underlie results will be made publicly available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No