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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03241316
Other study ID # BACN001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date October 31, 2018

Study information

Verified date November 2018
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 (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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 5885
Est. completion date October 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country Name City State
Lao People's Democratic Republic Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit Vientiane
Thailand Chiangrai Clinical research Unit Chiang Rai Chiangrai

Sponsors (4)

Lead Sponsor Collaborator
University of Oxford Economic and Social Research Council, United Kingdom, Mae Fah Luang University, Mahidol Oxford Tropical Medicine Research Unit

Countries where clinical trial is conducted

Lao People's Democratic Republic,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary General population and villagelevel data on antibiotic access and use within individuals' healthcare-seeking pathways To improve the understanding of patients' antibiotic-related behaviour to support creative thinking about targeted and unconventional antimicrobial resistance (AMR) interventions in low- and middle-income countries (LMICs). The study is expected to take place from January 2017 to October 2018, with data collection scheduled for November 2017 to April 2018
Secondary Indicators of economic, social, and spatial marginalisation 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
Secondary Access to formal and informal medical treatment 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.
Secondary 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. The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Secondary Degree of technology use during the healthcare seeking process 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.
Secondary Awareness about "rational" antibiotic use 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.
Secondary 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. The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Secondary 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. The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Secondary 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. The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Secondary Proxy indicators that predict problematic antibiotic use in the general population 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.
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