Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT04358289

Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam

Led by Oxford University Clinical Research Unit, Vietnam · Updated on 2023-12-06

3315

Participants Needed

1

Research Sites

339 weeks

Total Duration

On this page

Sponsors

O

Oxford University Clinical Research Unit, Vietnam

Lead Sponsor

N

National Institute of Hygiene and Epidemiology, Vietnam

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Commune officials consent to take part
  • Commune population larger than 3000 individuals
  • Active Women's Union and Farmers' Union groups with paid commune-level representatives
  • Commune health centre has a doctor
  • Commune health centre has electronic database
  • Participant is willing and able to give informed consent
  • Community members normally resident in the study commune for at least three months
  • Commune health centres serve populations larger than 3000 individuals
  • Commune health centres have an average caseload of at least 10 consultations per week for acute respiratory infections
  • Health centre doctor is normally employed at the centre and has been there for at least three months
  • All patients' anonymised records for patient record review
Not Eligible

You will not qualify if you...

  • Urban areas with low proportion of farmers or low use of commune health centres for primary healthcare
  • Commune health centres with antibiotic prescription rates for acute respiratory infections below 40%
  • Patient records without national health insurance or not recorded

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nam Dinh province

Nam Định, Vietnam, 07000

Actively Recruiting

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Research Team

S

Sonia Lewycka, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

5

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