Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial

Area of Science:

• Global Health
• Pediatric Nutrition
• Humanitarian Research

Background:

• Rigorous evidence is essential for effective humanitarian aid, but research in crisis settings is difficult.
• The TISA trial investigated a Water, Sanitation and Hygiene (WASH) intervention for severe acute malnutrition (SAM) in children.

Purpose of the Study:

• To assess the impact of a WASH intervention combined with standard SAM treatment in children.
• To identify and analyze challenges encountered during the trial implementation in Senegal.

Main Methods:

• Utilized trial documentation and staff contributions to reconstruct the timeline and identify challenges.
• Categorized challenges as internal (consortium-related) or external (contextual).
• Enrolled over 2000 children aged 6-59 months with uncomplicated SAM across 86 treatment posts.

Main Results:

• The trial faced a 30-month delay and was extended due to COVID-19, strikes, and logistical issues.
• Internal challenges included logistics, staffing, data management, and stakeholder alignment.
• The intervention group received a WASH kit and hygiene promotion alongside standard SAM care.

Conclusions:

• The TISA trial concluded successfully despite numerous obstacles.
• Highlights the need for meticulous planning, strong coordination, and community engagement in humanitarian research.
• Emphasizes the importance of tailored monitoring, open communication, and transparency.