Clinical trial NCT04667767: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Action Contre la Faim
name: Cheikh Anta Diop University, Senegal
First posted: 2020-12-16
Enrollment: 2411
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of recovery
timeFrame: 8 weeks
Secondary outcomes:
measure: Weight gain
timeFrame: 8 weeks
measure: Rate of referral
timeFrame: 8 weeks
measure: Longitudinal prevalence of diarrhoea
timeFrame: 8 weeks
measure: Prevalence of enteric pathogen detection
timeFrame: 8 weeks
measure: All cause mortality
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Louga
country: Senegal
facility: ACF Senegal
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Oliver Cumming, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Action Contre La Faim - France
name: Dieynaba N'Diaye, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Cheikh Anta Diop de Dakar
name: Moustapha Seye, PhD
role: PRINCIPAL_INVESTIGATOR
References: