Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion

NCT03241316 | Completed DMC

• 1 other identifier: BACN001
• Study Type: observational
• Target: 5,885
• Locations: 2 countries
• Sites: 2

Brief Summary

The investigators will conduct two rural surveys in Thailand and Lao PDR to improve the understanding of antibiotic-related health behaviour among the general population. One survey will capture a cross-section of health behaviours that is representative for the rural population in Chiang Rai (Thailand) and Salavan (Lao PDR), the other survey will create a two round village-level panel data set to study the evolution of health behaviours in the context of public engagement activities. The investigators will also collect complementary data about village-level infrastructure through observational check-lists, and collect secondary data on patient load from primary care units catering to their survey villages. As part of the questionnaire testing process, the investigators will conduct (and collect as primary data) cognitive interviews to improve the survey tool, to interpret their data, and to justify their methodological choices.

Conditions

Antibiotic Use; Rural Healthcare-seeking Behaviour; Marginalisation (Economic, Social, Spatial)

Keywords

qualitative and survey research

Outcome Measures

Primary Outcomes (1)

• General population and villagelevel data on antibiotic access and use within individuals' healthcare-seeking pathways

  To improve the understanding of patients' antibiotic-related behaviour to support creative thinking about targeted and unconventional antimicrobial resistance (AMR) interventions in low- and middle-income countries (LMICs).

  The study is expected to take place from January 2017 to October 2018, with data collection scheduled for November 2017 to April 2018

Secondary Outcomes (9)

• Indicators of economic, social, and spatial marginalisation

  The study is expected to take place from January 2017 to October 2018, with data collection scheduled for November 2017 to April 2018

• Access to formal and informal medical treatment

  The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.

• Access to prescription and over-the-counter medicines including antibiotics

  The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.

• Degree of technology use during the healthcare seeking process

  The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.

• Awareness about "rational" antibiotic use

  The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.

Study Arms (2)

district-level representative rural survey

Approximately 4,800 adults in 60 villages across Thailand and Lao PDR to study health and antimicrobial resistance (AMR)-related behaviour in breadth.

Behavioral: Observational study of behaviour

village-level social network census

Approximately 4,800 adults across 6 villages in rural Thailand and Lao PDR that are exposed to AMR awareness activities to study health behaviour within social networks.

Behavioral: Observational study of behaviour

Interventions

Observational study of behaviour BEHAVIORAL

As a general population survey, our study does not involve a control group. Please note that the investigators do not interview patients; we involve only healthy members of the general public who consider themselves fit to be interviewed.

district-level representative rural survey; village-level social network census

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Groups included in this study comprise adults (aged 18 years and above) in rural Lao PDR (Salavan) and in rural Thailand (Chiang Rai). As a general population survey, the study does not involve a control group. Please note that the investigators do not interview patients; the investigators involve only healthy members of the general public who consider themselves fit to be interviewed. Sampling method: 1.3-stage stratified random cluster sampling 2.Complete census of all adults among 3 purposively sampled villages per country

You may qualify if:

• Any villager in rural Chiang Rai (Thailand) or Salavan (Lao PDR) who had been sampled to participate in the survey
• Is willing and able to give informed consent for participation in the study
• Is aged 18 years and above

You may not qualify if:

• Respondent is not available or able to participate in interview after two attempts to arrange for appointment

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Economic and Social Research Council, United Kingdom: collaborator
• Mae Fah Luang University: collaborator

Study Sites (2)

Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit

Vientiane, Laos

Location

Chiangrai Clinical research Unit

Chiang Rai, Chiangrai, 50007, Thailand

Location

Related Publications (3)

• Haenssgen MJ, Charoenboon N, Xayavong T, Althaus T. Precarity and clinical determinants of healthcare-seeking behaviour and antibiotic use in rural Laos and Thailand. BMJ Glob Health. 2020 Dec;5(12):e003779. doi: 10.1136/bmjgh-2020-003779.

  PMID: 33298471 DERIVED

• Haenssgen MJ, Charoenboon N, Zanello G, Mayxay M, Reed-Tsochas F, Lubell Y, Wertheim H, Lienert J, Xayavong T, Khine Zaw Y, Thepkhamkong A, Sithongdeng N, Khamsoukthavong N, Phanthavong C, Boualaiseng S, Vongsavang S, Wibunjak K, Chai-In P, Thavethanutthanawin P, Althaus T, Greer RC, Nedsuwan S, Wangrangsimakul T, Limmathurotsakul D, Elliott E, Ariana P. Antibiotic knowledge, attitudes and practices: new insights from cross-sectional rural health behaviour surveys in low-income and middle-income South-East Asia. BMJ Open. 2019 Aug 20;9(8):e028224. doi: 10.1136/bmjopen-2018-028224.

  PMID: 31434769 DERIVED

• Haenssgen MJ, Charoenboon N, Zanello G, Mayxay M, Reed-Tsochas F, Jones COH, Kosaikanont R, Praphattong P, Manohan P, Lubell Y, Newton PN, Keomany S, Wertheim HFL, Lienert J, Xayavong T, Warapikuptanun P, Khine Zaw Y, U-Thong P, Benjaroon P, Sangkham N, Wibunjak K, Chai-In P, Chailert S, Thavethanutthanawin P, Promsutt K, Thepkhamkong A, Sithongdeng N, Keovilayvanh M, Khamsoukthavong N, Phanthasomchit P, Phanthavong C, Boualaiseng S, Vongsavang S, Greer RC, Althaus T, Nedsuwan S, Intralawan D, Wangrangsimakul T, Limmathurotsakul D, Ariana P. Antibiotics and activity spaces: protocol of an exploratory study of behaviour, marginalisation and knowledge diffusion. BMJ Glob Health. 2018 Mar 28;3(2):e000621. doi: 10.1136/bmjgh-2017-000621. eCollection 2018.

  PMID: 29629190 DERIVED

Study Officials

• Marco Haenssgen, Dr.

  Mahidol Oxford Tropical Medicine Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 7, 2017
• Study Start: January 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data access on the UK Data Service will be free and without a case-by-case assessment, provided repository users agree to the terms and conditions of the UK Data Service and to cite the data sources in all publications emerging from the data, using suggested citations. Data preparation and documentation process will commence in May 2018; deposition will take place within three months of project completion. The data sets will also be utilised as training resources in the context of global health education and social network analysis
• Access Criteria: Direct access will be granted to authorised representatives from the sponsor or host institution for monitoring and/or audit of the study to ensure compliance with regulations. Following data entry and validation, we will deposit the de-identified quantitative survey data with the UK Data Service for open access. Data access will be free and without a case-by-case assessment, provided repository users agree to the terms and conditions of the UK Data Service and to cite the data sources in all publications emerging from the data, using suggested citations (see Section 10.6 on Data Sharing for further details). The qualitative data from the cognitive interviews will not be made open access or shared with other researchers.

Locations

TH (1); LA (1)