Assessing the Effectiveness of a Multicomponent Intervention on Hand Hygiene and Well-Being in Primary Health Care Centers and Schools Lacking Functional Water Supply in Protracted Conflict Settings: Protocol for a Cluster Randomized Controlled Trial
Authors: Galli Anaïs , Ma'ani Abuzahra Yaman , Bänziger Carola , Ballo Aboubacar , Friedrich Max N D , Gross Karin , Harter Miriam , Hattendorf Jan , Peter Maryna , Tamas Andrea , Owen Branwen N , Winkler Mirko S 
Published: February 2024

Background
Hand hygiene is crucial in health care centers and schools to avoid disease transmission. Currently, little is known about hand hygiene in such facilities in protracted conflict settings.

Objective
This protocol aims to assess the effectiveness of a multicomponent hand hygiene intervention on handwashing behavior, underlying behavioral factors, and the well-being of health care workers and students. Moreover, we report our methodology and statistical analysis plan transparently.

Methods
This is a cluster randomized controlled trial with 2 parallel arms taking place in 4 countries for 1 year. In Burkina Faso and Mali, we worked in 24 primary health care centers per country, whereas in Nigeria and Palestine, we focused on 26 primary schools per country. Facilities were eligible if they were not connected to a functioning water source but were deemed accessible to the implementation partners. Moreover, health care centers were eligible if they had a maternity ward and ≥5 employees, and schools if they had ≤7000 students studying in grades 5 to 7. We used covariate-constrained randomization to assign intervention facilities that received a hardware, management and monitoring support, and behavior change. Control facilities will receive the same or improved intervention after endline data collection. To evaluate the intervention, at baseline and endline, we used a self-reported survey, structured handwashing observations, and hand-rinse samples. At follow-up, hand-rinse samples were dropped. Starting from the intervention implementation, we collected longitudinal data on hygiene-related health conditions and absenteeism. We also collected qualitative data with focus group discussions and interviews. Data were analyzed descriptively and with random effect regression models with the random effect at a cluster level. The primary outcome for health centers is the handwashing rate, defined as the number of times health care workers performed good handwashing practice with soap or alcohol-based handrub at one of the World Health Organization 5 moments for hand hygiene, divided by the number of moments for hand hygiene that presented themselves during the patient interaction within an hour of observation. For schools, the primary outcome is the number of students who washed their hands before eating.

Results
The baseline data collection across all countries lasted from February to June 2023. We collected data from 135 and 174 health care workers in Burkina Faso and Mali, respectively. In Nigeria, we collected data from 1300 students and in Palestine from 1127 students. The endline data collection began in February 2024.

Conclusions
This is one of the first studies investigating hand hygiene in primary health care centers and schools in protracted conflict settings. With our strong study design, we expect to support local policy makers and humanitarian organizations in developing sustainable agendas for hygiene promotion.

Trial Registration
ClinicalTrials.gov NCT05946980 (Burkina Faso and Mali); https://www.clinicaltrials.gov/study/NCT05946980 and NCT05964478 (Nigeria and Palestine); https://www.clinicaltrials.gov/study/NCT05964478

International Registered Report Identifier (IRRID)
DERR1-10.2196/52959