EpidemiologyNCT03087214
Human Movement Patterns on the Thailand-Myanmar Border
An observational study of Epidemiology, run by University of Oxford at 1 site in Thailand.
Trial summary
The epidemiology and ecology of malaria in humans includes complex interactions between human hosts and mosquito vectors. These interactions are spatio-temporal in nature and are heavily dependent on transportation capabilities and seasonal conditions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Epidemiology
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- 14 Mar 2017to 17 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: * The participants are Karen or Burmese ethnic group * Participants must be above 20 years of age * capable of keeping track of the device * walking beyond village boundaries * willing to consent to the study
Who may be able to join
- The participants are Karen or Burmese ethnic group
- Participants must be above 20 years of age
- Capable of keeping track of the device
- Walking beyond village boundaries
- Willing to consent to the study
Who cannot join
- Individuals who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Movement and Migration Patterns Among a Cohort of Villagers From the Thailand-Myanmar Border
The epidemiology and ecology of malaria in humans includes complex interactions between human hosts and mosquito vectors. These interactions are spatio-temporal in nature and are heavily dependent on transportation capabilities and seasonal conditions. Where and when infections are acquired is not well understood in the Greater Mekong Subregion (GMS), where there are numerous vectors, many with different behaviours and habitats. For example, many infections appear to be associated with forests or forest edges and some of the most important mosquito vectors in the region are forest dwellers (Obsomer, Defourny, and Coosemans 2007). Interventions that target houses at night-time (e.g. mosquito nets), have had limited success in the GMS, most likely because at least some infections are acquired during the day or outside of the home (Dolan et al. 1993; Luxemburger et al. 1994).
While overall malaria incidence in the region appears to be declining, the disease remains persistent in small subregions, for example along international borders joining Thailand with Myanmar. It will be crucial for elimination efforts to address the persistent malaria in these regions, most likely requiring the use of novel and spatially targeted approaches.
Read more
Increasingly, spatial data and analyses are used in disease research (Linard and Tatem 2012; Pybus et al. 2016; Tatem et al. 2012), however most spatial analyses are at aggregate scales, using data from provincial or state levels. More detailed studies have a single geographic reference point per individual in the study, frequently the home (Mosha et al. 2014; Parker et al. 2015). These studies allow researchers to investigate potential clustering of cases within and between houses ("hotspots") (Bejon et al. 2014; Bousema et al. 2012; Mosha et al. 2014). Even these detailed studies typically ignore the spaces in which people spend time outside of their home and where they may acquire infection: schools; places of worship and work; forest camps and temporary shelters. Given that many malaria infections in the GMS are acquired outside of the home, in areas that are not usually mapped, this information is important for developing strategies to prevent transmission and will be crucial for achieving elimination.
Researchers in other substantive areas have already begun mapping the movement patterns of study subjects so that exposure to a variety of environmental exposures outside of the home can be assessed (Matthews and Yang 2013; Vazquez-Prokopec et al. 2010). Early approaches relied on travel surveys or travel diaries, both having bias of unknown magnitude. Modern wearable global positioning satellite (GPS) instruments (loggers or trackers) and geographic information science (GIS) enable detailed mapping and quantification of human movement patterns. Through analysing differences in the movement patterns between humans who do versus those that do not acquire infectious diseases, it may be possible to identify a narrower set of geographic spaces in which disease transmission is occurring. Public health interventions could then target those risk areas.
Most of these detailed studies have been done in economically developed settings and urban environments. Infectious diseases such as malaria remain persistent in resource-poor, rural, and remote areas - the very regions that are least likely to be studied with detailed approaches (Sachs and Malaney 2002).
- Conditions
- Epidemiology
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-stamped locations
A series of spatial data sets that can then be mapped and analyzed
Measured: 1 year
The latitude and longitude of the GPS logging reading.
The GPS logging devices will automatically take a reading every 30 minutes.
Measured: 1 year
The elevation of the GPS logging reading.
The GPS logging devices will automatically take a reading every 30 minutes.
Measured: 1 year
Date and time of the GPS logging reading.
The GPS logging devices will automatically take a reading every 30 minutes.
Measured: 1 year
Acceptability among participants about carrying the GPS logging device during
Participants will also be interviewed throughout the study period and one of the research questions
Measured: 1 year
Secondary outcomes (1)
Questionnaires
Participants' reported travel histories comparing them to the GPS logger data.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start14 Mar 2017
- Primary completion17 Feb 2018
- Study completion17 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpidemiologyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087214
- Sponsor's protocol ID
- SMRU1607
- Status last verified
- Jan 2019
- First submitted
- 8 Mar 2017
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement and Migration Patterns Among a Cohort of Villagers From the Thailand-Myanmar Border
- ClinicalTrials.gov ID
- NCT03087214
- Acronym / sponsor ID
- SMRU1607
- Conditions
- Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 17 Feb 2018 (actual)
- Study completion
- 17 Feb 2018 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The epidemiology and ecology of malaria in humans includes complex interactions between human hosts and mosquito vectors. These interactions are spatio-temporal in nature and are heavily dependent on transportation capabilities and seasonal conditions. Where and when infections are acquired is not well understood in the Greater Mekong Subregion (GMS), where there are numerous vectors, many with different behaviours and habitats. For example, many infections appear to be associated with forests or forest edges and some of the most important mosquito vectors in the region are forest dwellers (Obsomer, Defourny, and Coosemans 2007). Interventions that target houses at night-time (e.g. mosquito nets), have had limited success in the GMS, most likely because at least some infections are acquired during the day or outside of the home (Dolan et al. 1993; Luxemburger et al. 1994).
While overall malaria incidence in the region appears to be declining, the disease remains persistent in small subregions, for example along international borders joining Thailand with Myanmar. It will be crucial for elimination efforts to address the persistent malaria in these regions, most likely requiring the use of novel and spatially targeted approaches.
Increasingly, spatial data and analyses are used in disease research (Linard and Tatem 2012; Pybus et al. 2016; Tatem et al. 2012), however most spatial analyses are at aggregate scales, using data from provincial or state levels. More detailed studies have a single geographic reference point per individual in the study, frequently the home (Mosha et al. 2014; Parker et al. 2015). These studies allow researchers to investigate potential clustering of cases within and between houses ("hotspots") (Bejon et al. 2014; Bousema et al. 2012; Mosha et al. 2014). Even these detailed studies typically ignore the spaces in which people spend time outside of their home and where they may acquire infection: schools; places of worship and work; forest camps and temporary shelters. Given that many malaria infections in the GMS are acquired outside of the home, in areas that are not usually mapped, this information is important for developing strategies to prevent transmission and will be crucial for achieving elimination.
Researchers in other substantive areas have already begun mapping the movement patterns of study subjects so that exposure to a variety of environmental exposures outside of the home can be assessed (Matthews and Yang 2013; Vazquez-Prokopec et al. 2010). Early approaches relied on travel surveys or travel diaries, both having bias of unknown magnitude. Modern wearable global positioning satellite (GPS) instruments (loggers or trackers) and geographic information science (GIS) enable detailed mapping and quantification of human movement patterns. Through analysing differences in the movement patterns between humans who do versus those that do not acquire infectious diseases, it may be possible to identify a narrower set of geographic spaces in which disease transmission is occurring. Public health interventions could then target those risk areas.
Most of these detailed studies have been done in economically developed settings and urban environments. Infectious diseases such as malaria remain persistent in resource-poor, rural, and remote areas - the very regions that are least likely to be studied with detailed approaches (Sachs and Malaney 2002).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * The participants are Karen or Burmese ethnic group * Participants must be above 20 years of age * capable of keeping track of the device * walking beyond village boundaries * willing to consent to the study
Key inclusion criteria (5 listed)
- The participants are Karen or Burmese ethnic group
- Participants must be above 20 years of age
- Capable of keeping track of the device
- Walking beyond village boundaries
- Willing to consent to the study
Key exclusion criteria (1 listed)
- Individuals who do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time-stamped locations
Time frame: 1 year
A series of spatial data sets that can then be mapped and analyzed
The latitude and longitude of the GPS logging reading.
Time frame: 1 year
The GPS logging devices will automatically take a reading every 30 minutes.
The elevation of the GPS logging reading.
Time frame: 1 year
The GPS logging devices will automatically take a reading every 30 minutes.
Date and time of the GPS logging reading.
Time frame: 1 year
The GPS logging devices will automatically take a reading every 30 minutes.
Acceptability among participants about carrying the GPS logging device during
Time frame: 1 year
Participants will also be interviewed throughout the study period and one of the research questions
1 secondary outcome
Questionnaires
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-stamped locations (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.