Antibiotic UseESRCNCT03241316
Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion
An observational study of Antibiotic Use and Rural Healthcare-seeking Behaviour, run by University of Oxford at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Use, Rural Healthcare-seeking Behaviour, Marginalisation (Economic, Social, Spatial)
- What is being tested?
- Observational study of behaviour
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,885 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2017to 31 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Respondent is not available or able to participate in interview after two attempts to arrange for appointment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the detailed description
The investigators will collect two data sets each in Lao PDR and Thailand: the first contains district-level representative health behaviour of approx. 2,400 adults across 30 rural communities per country (4,800 in total; representing rural populations of approx. 1-2 million adults); the second is a complete social network census of approx. 1600 adults each in three rural communities per country (approx. 4,800 in total). Within the sampled villages, the investigators will complete checklists about existing formal and informal healthcare facilities and gather patient load data from primary care units catering to the respective 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 our data, and to justify our methodological choices. The investigators will carry out the district-level village survey in one round, and the village-level social network censuses in two rounds. Between the two village social network censuses, the investigators will engage in public engagement activities in the selected villages (focused on antibiotic use) and re-survey all adults in the three villages per country two to three months later.
Objectives:
The primary objective is 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 investigators strive to achieve this primary objective by informing three research questions in Chiang Rai (Thailand) and Salavan (Lao PDR):
- What are the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways?
- Will people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices?
- Which proxy indicators facilitate the detection of problematic antibiotic behaviours across and within communities?
- Conditions
- Antibiotic Use, Rural Healthcare-seeking Behaviour, Marginalisation (Economic, Social, Spatial)
- Being tested
- Observational study of behaviour
- Keywords
- qualitative and survey research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study of behaviourBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Observational study of behaviour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
Measured: 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
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
Measured: 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
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
Measured: 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
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
Measured: 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
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
Measured: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Typologies of desirable and undesirable healthcare practices with respect to antibiotic use
To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
Measured: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Social network structures in rural communities
To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
Measured: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Demand fluctuations for healthcare services over time within rural communities
To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
Measured: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Proxy indicators that predict problematic antibiotic use in the general population
To identify less data-intensive indicators to detect problematic contexts of antibiotic use
Measured: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Jan 2017
- Primary completion31 May 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Antibiotic UseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 5,885 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Economic and Social Research Council, United Kingdom, Mae Fah Luang University
- Responsible party
- Sponsor
- Investigators
- Marco Haenssgen, Dr., Principal investigator, Mahidol Oxford Tropical Medicine Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241316
- Sponsor's protocol ID
- BACN001
- Acronym
- ESRC
- Status last verified
- Nov 2018
- First submitted
- 25 Jul 2017
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for this study will be de-identified and may be shared with other groups of researchers in accordance with the current MORU Data Sharing Policy provided the respondents consented to data sharing. Specifically, the investigators aim to make their survey data publicly available on the UK Data Service and other local and regional data sharing platforms like the Thai data service in order to enable other researchers the opportunity to study antibiotic-related behaviour in Thailand and Lao PDR.
Publications
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.
PubMed 33298471Haenssgen 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.
PubMed 31434769Haenssgen 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.
PubMed 29629190
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion
- ClinicalTrials.gov ID
- NCT03241316
- Acronym / sponsor ID
- ESRC / BACN001
- Conditions
- Antibiotic Use, Rural Healthcare-seeking Behaviour, Marginalisation (Economic, Social, Spatial)
- Keywords
- qualitative and survey research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,885 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Economic and Social Research Council, United Kingdom, Mae Fah Luang University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will collect two data sets each in Lao PDR and Thailand: the first contains district-level representative health behaviour of approx. 2,400 adults across 30 rural communities per country (4,800 in total; representing rural populations of approx. 1-2 million adults); the second is a complete social network census of approx. 1600 adults each in three rural communities per country (approx. 4,800 in total). Within the sampled villages, the investigators will complete checklists about existing formal and informal healthcare facilities and gather patient load data from primary care units catering to the respective 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 our data, and to justify our methodological choices. The investigators will carry out the district-level village survey in one round, and the village-level social network censuses in two rounds. Between the two village social network censuses, the investigators will engage in public engagement activities in the selected villages (focused on antibiotic use) and re-survey all adults in the three villages per country two to three months later.
Objectives:
The primary objective is 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 investigators strive to achieve this primary objective by informing three research questions in Chiang Rai (Thailand) and Salavan (Lao PDR):
- What are the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways?
- Will people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices?
- Which proxy indicators facilitate the detection of problematic antibiotic behaviours across and within communities?
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| district-level representative rural survey | – | Behavioral: Observational study of behaviourApproximately 4,800 adults in 60 villages across Thailand and Lao PDR to study health and antimicrobial resistance (AMR)-related behaviour in breadth. |
| village-level social network census | – | Behavioral: Observational study of behaviourApproximately 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Respondent is not available or able to participate in interview after two attempts to arrange for appointment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study of behaviourAs 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. | Behavioural | district-level representative rural survey, village-level social network census |
Primary outcome
General population and villagelevel data on antibiotic access and use within individuals' healthcare-seeking pathways
Time frame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for November 2017 to April 2018
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).
9 secondary outcomes
Indicators of economic, social, and spatial marginalisation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Typologies of desirable and undesirable healthcare practices with respect to antibiotic use
Time frame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Social network structures in rural communities
Time frame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Demand fluctuations for healthcare services over time within rural communities
Time frame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Proxy indicators that predict problematic antibiotic use in the general population
Time frame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Derived from this study: PubMed 33298471Haenssgen 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.
- Derived from this study: PubMed 31434769Haenssgen 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.
- Derived from this study: PubMed 29629190Haenssgen 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.
- Individual participant dataSharing planned: Yes. Data collected for this study will be de-identified and may be shared with other groups of researchers in accordance with the current MORU Data Sharing Policy provided the respondents consented to data sharing. Specifically, the investigators aim to make their survey data publicly available on the UK Data Service and other local and regional data sharing platforms like the Thai data service in order to enable other researchers the opportunity to study antibiotic-related behaviour in Thailand and Lao PDR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Haenssgen, Dr. principal investigator
Mahidol Oxford Tropical Medicine Unit
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Use and Rural Healthcare-seeking Behaviour, run by University of Oxford at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Laos, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General population and villagelevel data on antibiotic access and use within individuals' healthcare-seeking pathways (time frame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for November 2017 to April 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241316, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018; AzTrials last refreshed its copy on 31 Oct 2026.