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

November 6, 2018 updated by: University of Oxford
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5885

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lao People's Democratic Republic
      • Vientiane, Lao People's Democratic Republic
        • Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit
  • Thailand
    • Chiangrai
      • Chiang Rai, Chiangrai, Thailand, 50007
        • Chiangrai Clinical research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
The study is expected to take place from January 2017 to October 2018, with data collection scheduled for November 2017 to April 2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
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.
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
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.
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
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.
To understand the manifestations and determinants of problematic antibiotic use in patients' healthcare-seeking pathways.
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.
To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
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.
To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
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.
To understand whether people's exposure to antibiotic awareness activities entail changed behaviours that diffuse or dissipate within a network of competing healthcare practices.
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.
To identify less data-intensive indicators to detect problematic contexts of antibiotic use
The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mahidol Oxford Tropical Medicine Research Unit
Economic and Social Research Council, United Kingdom
Mae Fah Luang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marco Haenssgen, Dr., Mahidol Oxford Tropical Medicine Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BACN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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 Sharing 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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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