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

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ClinicalTrials.gov Identifier: NCT03241316
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
Mahidol Oxford Tropical Medicine Research Unit
Economic and Social Research Council, United Kingdom
Mae Fah Luang University
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.

Condition or disease Intervention/treatment
Antibiotic Use Rural Healthcare-seeking Behaviour Marginalisation (Economic, Social, Spatial) Behavioral: Observational study of behaviour

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):

  1. What are the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways?
  2. Will people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices?
  3. Which proxy indicators facilitate the detection of problematic antibiotic behaviours across and within communities?
Study Design
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Study Type : Observational
Actual Enrollment : 5885 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 ]
    To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.

  2. 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. ]
    To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.

  3. 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. ]
    To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.

  4. 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. ]
    To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.

  5. 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. ]
    To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.

  6. 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. ]
    To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.

  7. 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. ]
    To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.

  8. 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. ]
    To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.

  9. 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. ]
    To identify less data-intensive indicators to detect problematic contexts of antibiotic use


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Respondent is not available or able to participate in interview after two attempts to arrange for appointment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241316


Locations
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Lao People's Democratic Republic
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit
Vientiane, Lao People's Democratic Republic
Thailand
Chiangrai Clinical research Unit
Chiang Rai, Chiangrai, Thailand, 50007
Sponsors and Collaborators
University of Oxford
Mahidol Oxford Tropical Medicine Research Unit
Economic and Social Research Council, United Kingdom
Mae Fah Luang University
Investigators
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Principal Investigator: Marco Haenssgen, Dr. Mahidol Oxford Tropical Medicine Unit
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03241316    
Other Study ID Numbers: BACN001
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.
URL: http://www.surveycto.com/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
qualitative and survey research