The TISA Trial - Senegal

NCT ID: NCT04667767

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2411 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2023-04-27

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.

Conditions

Severe Acute Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

WASH kit

Intervention Type: OTHER

WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.

Control

National standard outpatient treatment for uncomplicated severe acute malnutrition

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: OTHER

National standard outpatient treatment for uncomplicated severe acute malnutrition

Interventions

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.

Intervention Type: OTHER

Standard treatment

National standard outpatient treatment for uncomplicated severe acute malnutrition

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Action Contre la Faim

OTHER

Sponsor Role: collaborator

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Cumming, MSc

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Dieynaba N'Diaye, PhD

Role: PRINCIPAL_INVESTIGATOR

Action Contre La Faim - France

Moustapha Seye, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Cheikh Anta Diop de Dakar

Locations

ACF Senegal

Louga, , Senegal

Countries

Senegal

References

N'Diaye DS, Frison S, Ba M, Le ML, Cabo AE, Siroma F, Devort A, MacLeod C, Lapegue J, Seye M, Traore AB, Cerveau T, Leger D, Gallandat K, Gnokane Y, Brizuela AV, Stern S, Braun L, Cumming O. Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial. Trials. 2024 Sep 19;25(1):620. doi: 10.1186/s13063-024-08459-1.

Reference Type: DERIVED

PMID: 39300465 (View on PubMed)

Other Identifiers

2019-KEP-267

Identifier Type: -

Identifier Source: org_study_id