<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03241316</url>
  </required_header>
  <id_info>
    <org_study_id>BACN001</org_study_id>
    <nct_id>NCT03241316</nct_id>
  </id_info>
  <brief_title>Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion</brief_title>
  <acronym>ESRC</acronym>
  <official_title>Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mahidol Oxford Tropical Medicine Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Economic and Social Research Council, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mae Fah Luang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct two rural surveys in Thailand and Lao PDR to improve the&#xD;
      understanding of antibiotic-related health behaviour among the general population. One survey&#xD;
      will capture a cross-section of health behaviours that is representative for the rural&#xD;
      population in Chiang Rai (Thailand) and Salavan (Lao PDR), the other survey will create a two&#xD;
      round village-level panel data set to study the evolution of health behaviours in the context&#xD;
      of public engagement activities. The investigators will also collect complementary data about&#xD;
      village-level infrastructure through observational check-lists, and collect secondary data on&#xD;
      patient load from primary care units catering to their survey villages. As part of the&#xD;
      questionnaire testing process, the investigators will conduct (and collect as primary data)&#xD;
      cognitive interviews to improve the survey tool, to interpret their data, and to justify&#xD;
      their methodological choices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will collect two data sets each in Lao PDR and Thailand: the first contains&#xD;
      district-level representative health behaviour of approx. 2,400 adults across 30 rural&#xD;
      communities per country (4,800 in total; representing rural populations of approx. 1-2&#xD;
      million adults); the second is a complete social network census of approx. 1600 adults each&#xD;
      in three rural communities per country (approx. 4,800 in total). Within the sampled villages,&#xD;
      the investigators will complete checklists about existing formal and informal healthcare&#xD;
      facilities and gather patient load data from primary care units catering to the respective&#xD;
      villages. As part of the questionnaire testing process, the investigators will conduct (and&#xD;
      collect as primary data) cognitive interviews to improve the survey tool, to interpret our&#xD;
      data, and to justify our methodological choices. The investigators will carry out the&#xD;
      district-level village survey in one round, and the village-level social network censuses in&#xD;
      two rounds. Between the two village social network censuses, the investigators will engage in&#xD;
      public engagement activities in the selected villages (focused on antibiotic use) and&#xD;
      re-survey all adults in the three villages per country two to three months later.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The primary objective is to improve the understanding of patients' antibiotic-related&#xD;
      behaviour to support creative thinking about targeted and unconventional antimicrobial&#xD;
      resistance (AMR) interventions in low- and middle-income countries (LMICs).&#xD;
&#xD;
      The investigators strive to achieve this primary objective by informing three research&#xD;
      questions in Chiang Rai (Thailand) and Salavan (Lao PDR):&#xD;
&#xD;
        1. What are the manifestations and determinants of problematic antibiotic use in patients'&#xD;
           healthcare-seeking pathways?&#xD;
&#xD;
        2. Will people's exposure to antibiotic awareness activities entail changed behaviours that&#xD;
           diffuse or dissipate within a network of competing healthcare practices?&#xD;
&#xD;
        3. Which proxy indicators facilitate the detection of problematic antibiotic behaviours&#xD;
           across and within communities?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>General population and villagelevel data on antibiotic access and use within individuals' healthcare-seeking pathways</measure>
    <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</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Indicators of economic, social, and spatial marginalisation</measure>
    <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</time_frame>
    <description>To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access to formal and informal medical treatment</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access to prescription and over-the-counter medicines including antibiotics</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of technology use during the healthcare seeking process</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness about &quot;rational&quot; antibiotic use</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Typologies of desirable and undesirable healthcare practices with respect to antibiotic use</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social network structures in rural communities</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demand fluctuations for healthcare services over time within rural communities</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proxy indicators that predict problematic antibiotic use in the general population</measure>
    <time_frame>The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.</time_frame>
    <description>To identify less data-intensive indicators to detect problematic contexts of antibiotic use</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5885</enrollment>
  <condition>Antibiotic Use</condition>
  <condition>Rural Healthcare-seeking Behaviour</condition>
  <condition>Marginalisation (Economic, Social, Spatial)</condition>
  <arm_group>
    <arm_group_label>district-level representative rural survey</arm_group_label>
    <description>Approximately 4,800 adults in 60 villages across Thailand and Lao PDR to study health and antimicrobial resistance (AMR)-related behaviour in breadth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>village-level social network census</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Observational study of behaviour</intervention_name>
    <description>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.</description>
    <arm_group_label>district-level representative rural survey</arm_group_label>
    <arm_group_label>village-level social network census</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Groups included in this study comprise adults (aged 18 years and above) in rural Lao PDR&#xD;
        (Salavan) and in rural Thailand (Chiang Rai). As a general population survey, the study&#xD;
        does not involve a control group. Please note that the investigators do not interview&#xD;
        patients; the investigators involve only healthy members of the general public who consider&#xD;
        themselves fit to be interviewed.&#xD;
&#xD;
        Sampling method:&#xD;
&#xD;
        1.3-stage stratified random cluster sampling 2.Complete census of all adults among 3&#xD;
        purposively sampled villages per country&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any villager in rural Chiang Rai (Thailand) or Salavan (Lao PDR) who had been sampled&#xD;
             to participate in the survey&#xD;
&#xD;
          -  Is willing and able to give informed consent for participation in the study&#xD;
&#xD;
          -  Is aged 18 years and above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Respondent is not available or able to participate in interview after two attempts to&#xD;
             arrange for appointment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Haenssgen, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol Oxford Tropical Medicine Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit</name>
      <address>
        <city>Vientiane</city>
        <country>Lao People's Democratic Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiangrai Clinical research Unit</name>
      <address>
        <city>Chiang Rai</city>
        <state>Chiangrai</state>
        <zip>50007</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lao People's Democratic Republic</country>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>November 6, 2018</last_update_submitted>
  <last_update_submitted_qc>November 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>qualitative and survey research</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_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</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
    <ipd_url>http://www.surveycto.com/index.html</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03241316
org study id: BACN001
nct id: NCT03241316
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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?
observational model: Ecologic or Community
time perspective: Other
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
description: 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).
measure: 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
description: To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
measure: 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.
description: To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
measure: 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.
description: To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
measure: 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.
description: To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
measure: 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.
description: To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
measure: 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.
description: To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
measure: 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.
description: To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
measure: 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.
description: To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
measure: 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.
description: To identify less data-intensive indicators to detect problematic contexts of antibiotic use
arm group label: district-level representative rural survey
description: Approximately 4,800 adults in 60 villages across Thailand and Lao PDR to study health and antimicrobial resistance (AMR)-related behaviour in breadth.
arm group label: village-level social network census
description: 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.
intervention type: Behavioral
intervention name: Observational study of behaviour
description: 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.
arm group label: district-level representative rural survey
arm group label: village-level social network census
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marco Haenssgen, Dr.
role: Principal Investigator
affiliation: Mahidol Oxford Tropical Medicine Unit
facility: 
facility: 
country: Lao People's Democratic Republic
country: Thailand
responsible party type: Sponsor
sharing ipd: Yes
ipd 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.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd 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
ipd 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.
ipd url: http://www.surveycto.com/index.html