Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam
Recruiting now · Not applicable
Conditions studied: Antibiotic Use
In brief
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.
Key facts
- Study ID
- NCT04358289
- Run by
- Oxford University Clinical Research Unit, Vietnam
- People needed
- 3315
- Starts
- 2020-02-27
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2023-12-06
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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;
- Commune health centre has electronic database.
You may not qualify if…
- Urban areas with a low proportion of farmers or low utilisation of CHCs for primary healthcare.
- For study participants:
- Inclusion criteria:
- 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);
- Exclusion criteria:
- No one will be actively excluded from participating in this population-based study.
- For Commune Health Centers:
- Inclusion criteria:
- Serve a commune population larger than 3000 individuals;
- Have an average caseload of at least 10 consultations per facility per week for ARI verified by checking the database system of the provincial centre for disease control and prevention (CDC) where the implementation study is being conducted;
- Health centre doctor is normally employed at the centre and has been there for at least three months.
- Exclusion criteria:
- Low antibiotic prescription rate for ARI of below 40%.
- For Patient records:
- Inclusion criteria:
- All patients' anonymised records.
- Exclusion criteria:
- Don't have national health insurance/not recorded.
Where it is running
- Nam Dinh province — Nam Định, Vietnam (enrolling)
Full record on ClinicalTrials.gov
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