Clinical trial NCT03241316: Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion
Official title: Antibiotics and Activity Spaces: An Exploratory Study of Behaviour, Marginalisation, and Knowledge Diffusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Use
Rural Healthcare-seeking Behaviour
Marginalisation (Economic, Social, Spatial)
Keywords: qualitative and survey research
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
name: Economic and Social Research Council, United Kingdom
name: Mae Fah Luang University
First posted: 2017-08-07
Enrollment: 5885
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
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

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.

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?

Eligibility 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

Primary outcomes:
measure: General population and villagelevel data on antibiotic access and use within individuals' healthcare-seeking pathways
timeFrame: 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:
measure: Indicators of economic, social, and spatial marginalisation
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for November 2017 to April 2018
measure: Access to formal and informal medical treatment
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
measure: Access to prescription and over-the-counter medicines including antibiotics
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
measure: Degree of technology use during the healthcare seeking process
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
measure: Awareness about "rational" antibiotic use
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
measure: Typologies of desirable and undesirable healthcare practices with respect to antibiotic use
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
measure: Social network structures in rural communities
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
measure: Demand fluctuations for healthcare services over time within rural communities
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
measure: Proxy indicators that predict problematic antibiotic use in the general population
timeFrame: The study is expected to take place from January 2017 to October 2018, with data collection scheduled for April 2018.
Other outcomes:
Locations:
city: Vientiane
country: Lao People's Democratic Republic
facility: Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit
city: Chiang Rai
country: Thailand
facility: Chiangrai Clinical research Unit
state: Chiangrai
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Unit
name: Marco Haenssgen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Haenssgen 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.
citation: Haenssgen 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.