Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam

NCT04358289 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3315

Last updated 2023-12-06

No results posted yet for this study

Summary

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

  • Antibiotic Use

Interventions

OTHER

Basic antimicrobial stewardship education

Commune 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

OTHER

Participatory action research group in commune health center and community

* Establish a participatory action research group * Engagement with the group through participatory action research involving problem identification, planning change strategies, implementing strategies, and evaluation

OTHER

Antimicrobial stewardship program in hospitals

The 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

OTHER

Community education

Development of educational materials for the community and farmers; Disseminated of messages through posters, leaflets and local media channels

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER
  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358289 on ClinicalTrials.gov