Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam

1. Main research questions:

1.2.1 Community interventions: Can educational and participatory action research interventions delivered in the community reduce the inappropriate use of antibiotics? 1.2.2 Primary healthcare interventions: Can educational and participatory action research interventions delivered in primary healthcare reduce prescription of antibiotics for patients with acute respiratory infections, outside of the research context? 1.2.3 Hospital interventions: Can participatory action research interventions delivered in hospitals improve antibiotic stewardship and reduce prescription of antibiotics? 2. OBJECTIVES 2.1 Community interventions: to evaluate the impact of educational and participatory action research interventions in communities on the proportion of the population reporting antibiotic use in the last month 2.2 Primary healthcare interventions: to evaluate the impact of antibiotic stewardship training and participatory action research interventions on the proportion of patients with ARI prescribed an antibiotic in routine primary health care 2.3 Hospital interventions: to evaluate the impact of quality improvement using a participatory action research approach on antibiotic stewardship and the proportion of patients receiving antibiotic treatment 2.4 Qualitative evaluation: to understand community processes and engagement with behaviour change interventions 3. STUDY DESIGN 3.1 Design 3.1.1 and 3.1.2 Community and primary healthcare interventions: The community and primary healthcare interventions will be evaluated together through a four-armed cluster-randomised controlled trial design, consisting of 16 communes in each arm, with interventions delivered either at the commune health centre, the community, or both. The goal of the evaluation is to assess whether or not the community and primary healthcare interventions had a measurable impact on knowledge and behaviour. Each of the three intervention arms will be done in 16 communes, and the investigators will select a further 16 communes as controls, where there will be no intervention activities. At the beginning of the project, the investigators will randomly allocate 64 communes to receive one of the three interventions or no intervention.

3.1.3 Hospital interventions: The hospital interventions will use quality improvement using a participatory action research approach to improve antibiotic stewardship. These activities will be evaluated through a before and after knowledge, attitudes and practice (KAP) survey, to assess whether or not the engagement activities had a measurable impact on knowledge and behaviour. There are not sufficient hospitals in the area to conduct a cluster randomized evaluation, so the investigators will conduct a before and after survey, patient record review, and overall antibiotic use data from the Pharmacy Department.

3.1.4 Qualitative evaluation: The goal of the qualitative evaluation is to understand the group processes and community and health-worker engagement with the action groups, how the engagement activities affect behaviour, and in what contexts they work better or worse, in order to develop a theory of change. The investigators will conduct in-depth interviews and participant observation in selected communities, and at each of the participating hospitals, during each of the four phases of the meeting cycle, in order to understand decision-making processes, as well as influential social and power dynamics in the groups. Participant observation is a method used in research where the investigators engage with people and document the information: investigators document what people said, what they did, how they interacted within a given setting.

3.2 Study location The target population for both phases will be the general resident population of two to three districts in Nam Dinh Province, covering 64 rural communes. Investigators at the National Institute for Hygiene and Epidemiology (NIHE), have longstanding connections and experience of working with communities in this region and will take the lead in developing relationships with Provincial representatives.

3.3 Communities and study participants Engagement with communities will be run through Women's Union and Farmers' Union groups. The Women's Union is a national organisation promoting the health and wellbeing of women and families in Vietnam, and has widespread coverage and membership at community-level. Women's Union groups are run by paid representatives and meet regularly. The Farmers' Union is also a national organisation that promotes good farming practices. Farmers' Union groups are also run by paid representatives and meet regularly. During the strategy development phase of group activities, groups will be encouraged to invite local stakeholders to participate, including community healthcare workers, primary healthcare workers, animal healthcare workers, and pharmacists.

3.4 Commune health centres Commune health centres (CHCs) deliver most primary care services and national targeted health programmes to the population, especially in rural and mountainous areas including hygiene, vaccinations, antenatal care, safe delivery and health education. Screening examination, treatment and referrals for CHC attendees are also provided. Regarding coverage of commune health network in Vietnam, 99% of communes have a health centre, 70% have a doctor; and 79.3% provide traditional medicine services13.

• Community: Proportion of the population who have heard about antibiotic resistance [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Community: Proportion of the population who can correctly define antibiotic resistance (from a list of options) [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• 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) [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Community: Average number of days of illness in the last month [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Community: Average number of days unable to do usual activities due to illness (e.g. absent from school/work/farm work) in the last month [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Community: Proportion of farmers who can correctly identify at least two farming behaviours that can lead to antibiotic resistance (from a list of options) [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Primary healthcare: The proportion of patients that consulted with ARI in the preceding year [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Primary healthcare: Prescription rates for ARI patients in the preceding year [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Primary healthcare: Proportion of patients receiving an antibiotic with the denominator being [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Primary healthcare: Proportion of patients receiving an antibiotic prescription by diagnosis, age, season, recorded fever, sex [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Primary healthcare: The proportion of patients referred to a higher-level facility at the initial consultation by checking the e-database of health insurance (HI) reimbursement [Срок оценки: After the last interview/survey, up to 18 months since study implementation]
• Hospital: Changes in knowledge and perceptions pf doctors in the month before the intervention starts, and the last month of intervention implementation [Срок оценки: After the last interview/survey, up to 18 months since study implementation]