Effect of a community-based behavioural intervention bundle to improve antibiotic use and patient management in Burkina Faso and DR Congo: a cluster randomized controlled trial

Background
Increasing Watch-group antibiotic use may be contributing to antimicrobial resistance burden in sub-Saharan Africa. We evaluated the effect of a community-based, co-created intervention bundle targeting all community-level healthcare providers and communities they serve, on Watch-group antibiotic use and patient management.
Methods
In a cluster-randomised, controlled trial in Burkina Faso (BF) and Democratic Republic of Congo (DRC), 44 villages with [≥]500 inhabitants and [≥]1 health centre or medicine vendor were randomly allocated 1:1 to intervention or control arms, using the RAND function in Excel. Over nine months, three intervention rounds consisted of community health education campaigns and educational/feedback sessions with providers, introducing AWaRe Book guidance for infections with highest antibiotic use. We measured baseline-to-post-intervention changes in Watch-group antibiotic use through repeated patient surveys (100 per provider per village), cluster-adjusted and offset for healthcare utilisation (primary outcome), and patient management through simulated patient visits (secondary outcome). Field workers conducting patient surveys and simulated patient visits were masked. CABU-EICO was registered on clinicaltrials.gov/study/NCT05378880.
Findings
At baseline (Oct 26, 2022 to Mar 13, 2023), 5532 patients were surveyed (3558 in BF; 1974 in DRC); post-intervention (Nov 6, 2023 to Apr 3, 2024), 4898 patients (3180 in BF; 1718 in DRC). Surveys were completed at 63 health centres, 60 pharmacies, and 41 informal vendors. A total of 1092 simulated patient visits were completed across both periods. Weighted prevalence of Watch-group antibiotic use decreased from 26{middle dot}8% (95%CI 8{middle dot}8-44{middle dot}8) to 17{middle dot}1% (95%CI 7{middle dot}7-26{middle dot}5) in intervention and increased from 13{middle dot}4% (95%CI4{middle dot}8-22) to 21.2% (95%CI8{middle dot}9-34) in control clusters; adjusted prevalence ratio 0{middle dot}33 (95%CI 0{middle dot}14-0{middle dot}78). Changes in patient management scores were limited.
Interpretation
The behavioural intervention bundle substantially reduced Watch-group antibiotic use and did not negatively impact patient management, highlighting the potential of antibiotic use improvements across healthcare providers. Reduced community-level use of broad-spectrum antibiotics could help slow community-acquired pathogens increasing resistance to clinically important antibiotics.
Funding
JPI-AMR, Research Foundation-Flanders
Evidence before this study
Evidence on the effectiveness of interventions to improve antibiotic use in primary care in low- and middle-income countries (LMIC) is heterogenous, in terms of intervention components and effect sizes. A systematic review of behavioural interventions in LMIC between 2001 and 2019 analysed 13 studies in health centres, private clinics, and pharmacies. We complemented the review with a search on Pubmed for interventional studies in primary care or community-level in LMIC since 2019, using ("Anti-Bacterial Agents" OR "Antimicrobial Stewardship") AND ("Guideline Adherence" OR "Education, Medical, Continuing" OR "Feedback" OR "Decision Support Systems, Clinical" OR "Drug Utilization Review" OR "Clinical Protocols" OR "prescription audit") AND ("Ambulatory Care" OR "Primary Health Care" OR "Outpatients" OR "Pharmacies" OR "Nonprescription Drugs"). Most interventions consisted of educational sessions on treatment guidance, with or without feedback, or combined with clinical algorithms. Studies conducted in Vietnam, Sudan, Tanzania, India, Kenya, and China reported reductions in inappropriate antibiotic prescribing ranging by 16 (audit/feedback alone, Sudan) to 55 percentage point (84.3% to 15.4%, Tanzania), with the largest effects consistently seen in bundle interventions combining education, audit and feedback, and regulatory enforcement.
Evidence concerning interventions among informal healthcare providers is scarcer: provision of educational sessions for informal medicine vendors in India was not linked to a change in prevalence of antibiotic use but did improve patient management. A systematic review of studies in sub-Saharan Africa published up to 2020 found that populations frequently self-medicated with antibiotics, obtained without prescription from community pharmacies or (informal) medicine vendors.
Added value of this study
The study evaluated a co-created intervention bundle that simultaneously targeted both antibiotic dispensing by healthcare providers or vendors and the demand from the communities they serve, which, to our knowledge, no previous published study did. Three intervention rounds consisted of health education campaigns with communities and educational and feedback sessions with providers, introducing AWaRe Book guidance for infections with highest antibiotic use. By including all community-level providers and vendors in both the intervention and its evaluation, and by adjusting community-level antibiotic-use prevalence for healthcare utilisation, we were able to estimate effects on community-wide antibiotic use. The intervention study was conducted in two sites in Sub-Saharan Africa, in Burkina Faso and DR Congo, with differences in antibiotic dispensing and in available healthcare providers. That the relative effect size was comparable between sites, despite baseline differences, supports external validity of the intervention bundles effectiveness.
We used simulated patient visits for five priority infections to assess changes in patient management and antibiotic dispensing. This approach enabled direct comparison of history taking, examination practices, and dispensing across provider types and intervention arms, offering insight into how the intervention influenced antibiotic use and clinical management. Together with detailed sub-analyses by infection and provider type, and qualitative interviews with providers and community members, the evaluation identified intervention components which appeared to be the most effective and could be prioritised in future, more targeted interventions.
Finally, this is the first experimental study to evaluate an intervention informed by the WHO AWaRe Antibiotic Book, which was published in December 2022, only two months before the study started..
Implications of all the available evidence
Contextualised behavioural interventions based on existing treatment guidance, focusing on a limited number of common primary-care infections, can substantially reduce antibiotic use and improve the selection of appropriate antibiotics, potentially slowing the increasing resistance of community-acquired pathogens to clinically important antibiotics. Reductions in antibiotic use were greatest in clinics and health centres, with private clinics contributing importantly to the reduction. Reducing antibiotic sales from medicine vendors proved difficult without stronger regulatory measures.