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

BackgroundSub-Saharan Africa has a high burden of disease due to antimicrobial resistance that is thought to be driven by a combination of sub-optimal antibiotic use and frequent exposures to AMR in different One Health compartments. We evaluated a community-based, co-created intervention bundle to improve antibiotic use and hygiene practices, targeting all community-level healthcare providers and communities. MethodsIn a cluster-randomised, controlled trial in 44 villages, we measured the intervention effect on antibiotic use through repeated patient surveys. Simulated patient visits, mimicking common infections, were used to monitor patient management. In 22 randomised intervention villages, three rounds of intervention activities (health education campaign, educational/feedback sessions) were implemented over nine months. Provider interventions focused on infections with highest antibiotic use, introducing WHO AWaRe Book guidance. Per provider type per village, 100 patient surveys and five simulated patient visits were conducted at baseline and post-intervention. Primary outcomes were the change in Watch antibiotic use and patient management scores. CABU-EICO was registered on clinicaltrials.gov/study/NCT05378880. FindingsDuring the baseline period (Oct 26, 2022 to Mar 13, 2023), 5532 patients were surveyed at 63 health centres, 60 pharmacies, and 41 informal vendors. Post-intervention (Nov 6, 2023 to Apr 3, 2024), 4898 patients were surveyed. A total of 1092 simulated patient visits were completed across both periods. Weighted prevalence of Watch-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) with a prevalence ratio (PR) of 0{middle dot}29 (95%CI 0{middle dot}10-0{middle dot}82). Use of any systemic antibiotics decreased from 56{middle dot}2 (95%CI 35{middle dot}9-76{middle dot}5) to 37{middle dot}5% (95%CI 28{middle dot}3-46{middle dot}7), PR 0{middle dot}48 (95%CI 0{middle dot}26-0{middle dot}88). At intervention health centres, patient management scores increased by 1{middle dot}5 points (95%CI -0{middle dot}77-3{middle dot}68), at informal vendors by 0{middle dot}29 points (95%CI -0{middle dot}21-0{middle dot}78). InterpretationThe low-cost behavioural intervention bundle more than halved Watch and overall antibiotic use and did not negatively impact patient management, highlighting the potential of antibiotic use improvements across healthcare providers. FundingJPI-AMR, Research Foundation-Flanders Research in contextO_ST_ABSEvidence before this studyC_ST_ABSEvidence on the effectiveness of interventions to improve antibiotic use in primary care in low- and middle-income countries (LMIC) is heterogenous, both in terms of intervention components and effect sizes. A systematic review of behavioural interventions in LMIC analysed eight experimental or quasi-experimental studies in health centres, two in private clinics, and three in community pharmacies. Most interventions consisted of educational sessions on treatment guidance, with or without feedback or supervision. The strongest evidence was found for combinations of education and feedback in primary care: for example, printing clinical guidance and providing educational sessions in Kenyan private clinics reduced prevalence of quinolone use from 30% to 16%. A treatment algorithm introduced in Tanzanian health centres reduced the prevalence of antibiotic use from 70% to 25% while improving checks for danger signs in children. 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 self-medication with antibiotics--obtained from community pharmacies or medicine vendors--is reported by more than half of respondents. Prior studies in the Nanoro and Kimpese study sites indicated that up to 50% of antibiotics were obtained from private providers, and that as much as 75% of Watch-group antibiotic use could have been substituted by either no antibiotic or an Access-group antibiotic, when treatment would be according to WHO AWaRe Book guidance. Added value of this studyTo our knowledge, no previous intervention has simultaneously targeted both antibiotic dispensing by healthcare providers or vendors and the demand from the communities they serve. 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. 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 clear insight into how the intervention influenced clinical management and antibiotic use. 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. Our findings demonstrate that an approach focusing on a small number of common primary-care infections can reduce overall antibiotic use and improve the selection of appropriate antibiotics. Implications of all the available evidenceLow-cost, contextualised behavioural interventions based on existing treatment guidance can substantially improve antibiotic use.