About this trial
The study aims to develop community-based interventions targetting inappropriate antibiotic dispensing and use behaviours in rural Vietnam and has 3 research components.
Community and primary healthcare interventions: The investigators will conduct a four-armed cluster randomised controlled trial. The first arm will be a control arm with no interventions. The second intervention arm will have a basic antimicrobial stewardship intervention, involving working with the Ministry of Health, Medical Services Administration to revise guidelines for antibiotic prescribing for acute respiratory infections (ARI) in primary care, and then training primary healthcare doctors in their use. The third intervention arm will have basic antimicrobial stewardship guidelines and training for primary healthcare doctors, plus educational materials for the community, disseminated through posters, leaflets and local media channels. The fourth intervention arm will use a participatory action research approach to engage primary healthcare doctors and communities, in addition to the basic guidelines and training materials. The participatory action research approach will train local facilitators to lead community and health-worker groups through a cycle of problem identification, strategy development, implementation and review, focusing on inappropriate human and small-scale agricultural use of antibiotics.
Hospital interventions: The investigators will work with Provincial and District Hospitals serving these communities to implement quality improvement cycles for antibiotic stewardship, also using a participatory action research approach. This will also follow a cycle of a cycle of problem identification, strategy development, implementation and review.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Commune officials consent to take part;
Have a commune population larger than 3000 individuals;
Have active Women's Union and Farmers' Union groups with a paid commune-level representative;
Commune health centre has a doctor;
Disqualifiers
Urban areas with a low proportion of farmers or low utilisation of CHCs for primary healthcare.
Participant is willing and able to give informed consent for participation in the study;
Community members normally resident in the study commune (living in the study commune and resident for at least three months);
No one will be actively excluded from participating in this population-based study.
Trial design
Parallel
Treatments tested in this trial
Basic antimicrobial stewardship education
Other interventionCommune health center: Revision of guidelines for antibiotic prescribing for respiratory infections in primary care, Training primary healthcare doctors in the application of the new guidelines
Participatory action research group in commune health center and community
Other intervention* Establish a participatory action research group * Engagement with the group through participatory action research involving problem identification, planning change strategies, implementing strategies, and evaluation
Antimicrobial stewardship program in hospitals
Other interventionThe intervention activities in hospitals will include: training a health-worker in each of the participating hospitals to act as a facilitator or "activator"; forming an antibiotic stewardship group; meeting regularly and following an action-research cycle that includes problem identification, planning change strategies, implementing strategies, and evaluating strategies
Community education
Other interventionDevelopment of educational materials for the community and farmers; Disseminated of messages through posters, leaflets and local media channels
Treatment groups
Trial outcomes
Primary outcomes
Community: Proportion of the population reporting antibiotic use in the last month
Community: Proportion of the population with a mild respiratory illness in the last month who didn't seek medical consultation and treatment (at a health facility or a pharmacy)
Community: Proportion of farmers reporting antibiotic use for their animals in the last month
Primary healthcare: Proportion of patients aged 1 to 65 years, consulting for ARI, who are prescribed antibiotics
Secondary outcomes
Community: Proportion of the population who have heard about antibiotic resistance
Community: Proportion of the population who can correctly define antibiotic resistance (from a list of options)
Community: Proportion of the population who can correctly identify at least two human health behaviours that can lead to antibiotic resistance (from a list of options)
Community: Average number of days of illness in the last month
Sponsors and contacts
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Oxford University Clinical Research Unit, Vietnam
Lead sponsor
National Institute of Hygiene and Epidemiology, Vietnam
Collaborator