Optimising Community Antibiotic Use and Infection Control With Behavioural Interventions in Burkina Faso and DR Congo

NCT05378880 | Completed

• 2 other identifiers: 1559/22JPMIR2021-053
• Study Type: interventional
• Target: 5,532
• Locations: 2 countries
• Sites: 2

Brief Summary

Emergence of antibiotic resistance (AMR) is a serious concern for Low and Middle Income Countries (LMICs). Unregulated use of antibiotics, a major AMR driver, is highly prevalent in LMICs, with medicine stores as key providers. Physical interactions between One Health compartments increase cross-domain transmission risks, although the relative importance of different reservoirs is uncertain, with community-level dynamics of AMR in LMICs largely unquantified. In two rural health districts in Burkina Faso and DR Congo, a behavioural intervention bundle will be developed, targeting medicine stores and their communities, to optimise antibiotic use and improve hygiene, and hence reduce AMR prevalence and transmission. After a 6-month local co-development phase, the intervention will be implemented over 12 months and evaluated through a comparison between intervention and control clusters, consisting of one or more villages or neighbourhoods largely seeking healthcare with the same provider(s). The primary outcome measure is the change in Watch antibiotic provision from medicine stores (where a formal prescription is not required), assessed via patient exit interviews and simulated client visits. Changes in hygiene practices and AMR pathogen and gene carriage will be assessed in repeated population surveys. Rodents, living in close proximity to humans in much of sub-Sahara Africa, provide a proxy estimate of environmental AMR pathogen and gene exposure. Using modelling and sequencing of selected isolates, impact of AMR transmission by changes in antibiotic use and hygiene practices will be quantified.

Conditions

Antimicrobial Stewardship; Drug Resistance, Bacterial

Keywords

behavioural intervention; sub-Sahara Africa; rodent surveillance; health demographic surveillance sites; Anti-Bacterial Agents / therapeutic use

Outcome Measures

Primary Outcomes (2)

• Change in the provision of Watch antibiotics

  The change pre- to post-intervention in prevalence of dispensing Watch antibiotics at medicine stores or health centers estimated through repeated patient visit exit surveys

  12 months (change between baseline before the intervention and 12 months later)

• Change in quality of care

  The change pre- to post-intervention in a score of case management at medicine stores or health centers, derived from a predefined checklist filled in during simulated patient visits for 5 clinical presentations. For clinical presentation-specific selected anamnesis questions, examinations, checked symptoms, advice or medicine prescribed/dispensed, a point is added (if appropriate) or deducted (if inappropriate). Checklists are predefined following the 2021 WHO Antibiotic Book and local guidelines, and are provided in the protocol

  12 months (change between baseline before the intervention and 12 months later)

Secondary Outcomes (3)

• Change in rate of person-to-person transmission and duration of carriage of ESBL-producing E.coli within households

  12 months (stool sample collection at 0, 3, 6 and 12 months)

• Change in hygiene practices and exposures

  12 months

• Change in dispensing of underdosed antibiotic courses

  12 months

Study Arms (2)

Intervention clusters

EXPERIMENTAL

Intervention bundle consisting of 3 components introduced over 12 months: one to improve antibiotic use targeting health centres and medicine stores and two targeting the general population: one to increase community health literacy and one to improve water, hygiene and sanitation practices.

Behavioral: Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission

Control clusters

NO INTERVENTION

Interventions

Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission BEHAVIORAL

The study teams will work with communities and authorities to develop, implement and evaluate a multifaceted intervention bundle that will optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission, by targeting the general public (including farmers) and medicine stores.

Intervention clusters

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Visitor to a medicine dispenser for his/her own health or that of someone else, regardless of disease or age

You may not qualify if:

• Simulated patient visits (dispensers)
• Prescribe or dispense medicines in a community pharmacy, medicine store, or other private clinic or outlet within the selected study clusters;
• Member of a household in a study cluster (resident for \>/= 3 months);
• Agreement of the household head for all household members (including children) to participate to the collection of four stool samples during the study period, through informed written consent;
• Individual informed consent (plus assent for adolescent participants) for each participating household member;
• Inhabitant of study clusters who planned to move or be absent during the following year;

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• Centre de Recherche en Santé de Kimpese: collaborator
• Universiteit Antwerpen: collaborator
• Institut Pasteur: collaborator
• University of Oxford: collaborator
• University of Cambridge: collaborator

Study Sites (2)

Clinical Research Unit of Nanoro (CRUN)

Nanoro, Burkina Faso

Location

Centre de Recherche en Santé de Kimpese (CRSK)

Kimpese, Democratic Republic of the Congo

Location

Related Publications (1)

• CABU-EICO consortium. 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). Trials. 2024 Jan 27;25(1):91. doi: 10.1186/s13063-023-07856-2.

  PMID: 38281023 RESULT

Study Officials

• Marianne AB van der Sande, PhD Pr

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The intervention consists of behavioural interventions, therefore masking of participants or care providers is not possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: May 18, 2022
• Primary Completion: April 3, 2024
• Study Completion: December 12, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Closure of the (pseudonymized) participant database is provisionally planned by June 2024. Anonymized datasets will be made accessible shortly after. Original study data will be kept for 20 years.
• Access Criteria: When data is made (openly) accessible, this will be done as much as possible in open, license-free and interoperable formats. We will also make available metadata necessary for further reinterpretation, reanalysis or use of the research results. We will endeavor to use open licenses such as CC-BY or CC-BY-NC as much as possible. Confidential data (such as pseudonymized participant data, therefore individual but without identifiers) can be made accessible through controlled access procedures (ITM Research data access committee via ITMresearchdataaccess@itg.be). A data sharing agreement will always be in place prior to the transfer of confidential data.

Locations

DE (1); BU (1)