Evaluating the effect of a behavioural intervention bundle on antibiotic use, quality of care, and household transmission of resistant Enterobacteriaceae in intervention versus control clusters in rural Burkina Faso and DR Congo (CABU-EICO)
Authors:   CABU-EICO consortium, van der Sande Marianne , Ingelbeen Brecht , Meudec Marie , van Kleef Esther , Campbell Linda , Wouters Edwin , Marien Joachim , van Vredendaal Rianne , Leirs Herwig , Valia Daniel , Yougbare Sibidou , Kouanda Juste Stephane , Welgo Aminata , Tinto Halidou , Mpanzu Delphin , Mbangi Bijou , Khoso Muaka Cesar-Augustin , Kiabanza Oscar , Melanda Adna , Makuaya Richelin , Ndomba Didier , Diagne Papa Mamadou , Heyerdahl Leonard , Giles-Vernick Tamara , Van Puyvelde Sandra , Cooper Ben 
Published: January 2024

Abstract
Background
Antimicrobial resistance (AMR) is a rising threat in low-resource settings, largely driven by transmission in the community, outside health facilities. Inappropriate antibiotic use is one of the main modifiable drivers of AMR. Its risk is especially high in poor resource settings, with limited diagnostic and surveillance capacities, and many informal medicine vendors determining community use. We hypothesise that to optimise community antibiotic use, especially Watch antibiotics (recommended only as first-choice for more severe clinical presentations or for causative pathogens likely to be resistant to Access antibiotics), both the supply side (medicine vendors) and the demand side (communities) should be pro-actively involved in any intervention.

Methods
In two existing demographic health surveillance sites (HDSS) in Burkina Faso and in the Democratic Republic of Congo, behavioural intervention bundles were co-created in a participatory approach, aiming to rationalise (Watch) antibiotic use and improve hygiene and sanitation practices. Bundles consisted of interactive interventions, including theatre, posters, discussions, etc. To evaluate impact, 11 of 22 clusters (a HDSS community with at least one (in)formal medicine vendor) were randomly assigned to this intervention, which will run over a year. The effect of the intervention will be evaluated by comparing outcomes before and after in intervention and control villages from a) exit interviews of clients from vendors, b) mystery patients presenting to vendors with a set of predefined symptoms, c) household interviews to assess behavioural changes related to antibiotic use, health literacy and water-sanitation-hygiene indicators. Long-term impact on AMR will be estimated by modelling changes in resistant Enterobacteriaceae carriage from repeated household surveys before, during and after the intervention in both arms.

Discussion
Most existing interventions aimed at improving antibiotic use focus on health care use, but in resource-limited settings, community use is highly prevalent. Previous studies targeting only providers failed to show an effect on antibiotic use. Evaluation will be done with before-after epidemiological measurements of actual prescriptions and use. If effective in reducing (Watch) antibiotic use, this would be an empowering methodology for communities, which has significant promise for long-term impact.

Trial registration
ClinicalTrials.govNCT05378880. 13 May 2022.