The TISA Trial - Senegal (TISA)

• ClinicalTrials.gov Identifier: NCT04667767
• Recruitment Status: Completed
• First Posted: December 16, 2020
• Last Update Posted: January 25, 2024
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Action Contre la Faim; Cheikh Anta Diop University, Senegal
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Severe Acute Malnutrition	Other: WASH kit; Other: Standard treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2411 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: December 22, 2020
• Actual Primary Completion Date: April 27, 2023
• Actual Study Completion Date: April 27, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Rate of recovery [ Time Frame: 8 weeks ]
   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.

Secondary Outcome Measures :

1. Weight gain [ Time Frame: 8 weeks ]
   Weight gain defined as grams of weight gained per kilogram per day between entry and exit.
2. Rate of referral [ Time Frame: 8 weeks ]
   Referral rate defined as number of participants referred/transferred to next level of care.
3. Longitudinal prevalence of diarrhoea [ Time Frame: 8 weeks ]
   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).
4. Prevalence of enteric pathogen detection [ Time Frame: 8 weeks ]
   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.
5. All cause mortality [ Time Frame: 8 weeks ]
   Deaths occurring during follow-up due to any cause.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 59 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Senegal

ACF Senegal

Louga, Senegal

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Action Contre la Faim

Cheikh Anta Diop University, Senegal

Investigators

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

More Information

• Responsible Party: London School of Hygiene and Tropical Medicine
• ClinicalTrials.gov Identifier: NCT04667767
• Other Study ID Numbers: 2019-KEP-267
• First Posted: December 16, 2020
• Last Update Posted: January 25, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All IPD that underlie results in a publication will be shared
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: December 2022
• Access Criteria: All IPD that underlie results will be made publicly available

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Malnutrition; Severe Acute Malnutrition; Nutrition Disorders