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

Tracking Information

• First Submitted Date: December 8, 2020
• First Posted Date: December 16, 2020
• Last Update Posted Date: January 25, 2024
• Actual Study Start Date: December 22, 2020
• Actual Primary Completion Date: April 27, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 8, 2020)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 8, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The TISA Trial - Senegal
• 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
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Severe Acute Malnutrition

Intervention

• 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.
• Other: Standard treatment
  National standard outpatient treatment for uncomplicated severe acute malnutrition

Study Arms

• 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.
  Intervention: Other: WASH kit
• Active Comparator: Control
  National standard outpatient treatment for uncomplicated severe acute malnutrition
  Intervention: Other: Standard treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2024): 2411
• Original Estimated Enrollment (submitted: December 8, 2020): 2000
• Actual Study Completion Date: April 27, 2023
• Actual Primary Completion Date: April 27, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 59 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Senegal

Administrative Information

• NCT Number: NCT04667767
• Other Study ID Numbers: 2019-KEP-267
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: December 2022
• Access Criteria: All IPD that underlie results will be made publicly available

• Current Responsible Party: London School of Hygiene and Tropical Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: London School of Hygiene and Tropical Medicine
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: January 2024