Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOxford University Clinical Research Unit, Vietnam

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Basic antimicrobial stewardship education

    Other intervention

    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

  • 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 intervention

    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

  • Community education

    Other intervention

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

Treatment groups

3,315 Participants
are divided into 5 treatment groups
Group A: Arm 1: Control groupNo intervention 0 interventions
Group B: Arm 2: Basic antimicrobial stewardship educationOther 1 intervention
Group C: Arm 3: 3. Basic AS education + community educationOther 2 interventions
Group D: Arm 4: Education + participatory action researchOther 3 interventions
Group E: Hospital interventionOther 1 intervention

Trial outcomes

Primary outcomes

1

Community: Proportion of the population reporting antibiotic use in the last month

Time frame
After the last interview/survey, up to 18 months since study implementation
2

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)

Time frame
After the last interview/survey, up to 18 months since study implementation
3

Community: Proportion of farmers reporting antibiotic use for their animals in the last month

Time frame
After the last interview/survey, up to 18 months since study implementation
4

Primary healthcare: Proportion of patients aged 1 to 65 years, consulting for ARI, who are prescribed antibiotics

Time frame
After the last interview/survey, up to 18 months since study implementation

Secondary outcomes

1

Community: Proportion of the population who have heard about antibiotic resistance

Time frame
After the last interview/survey, up to 18 months since study implementation
2

Community: Proportion of the population who can correctly define antibiotic resistance (from a list of options)

Time frame
After the last interview/survey, up to 18 months since study implementation
3

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)

Time frame
After the last interview/survey, up to 18 months since study implementation
4

Community: Average number of days of illness in the last month

Time frame
After the last interview/survey, up to 18 months since study implementation

Other outcomes

Sponsors and contacts

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Oxford University Clinical Research Unit, Vietnam

Lead sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Collaborator