ClinicalTrials.gg
CompletedNCT05389540SEACTN-HHSUpdated Feb 28, 2024

Rural South and Southeast Asia Household Health Survey

An observational study in Noncommunicable Disease, Infections and Risk Factors, sponsored by University of Oxford. Completed at 4 sites in 4 countries. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by University of Oxford · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
4,747
Sex
All
01

Study summary

A cross-sectional household survey with two-stage cluster-randomized sampling. This cross-sectional household survey design to recruit a random sample of households that is representative for each of the study sites. From the selected households, all consenting, household members will be included in the study.

This study is funded by the UK Wellcome Trust. The grant reference number is 215604/Z/19/Z

Read the detailed description

371 households will be randomly selected from each site in Bangladesh, Cambodia, Myanmar, and Thailand. Assuming each household has an average of 4.5 members and all members will be sampled, 1500 participants will be recruited per site. This sample size allows for the overall prevalence estimation of key survey indicators with 95% confidence and 5% degree of precision.

The survey components include questionnaire interview, physical examination, blood sample collection, and point of care (PoC) tests. The questionnaire interview will collect information on household characteristics, members' disability, presence or history of disease, risk factors, self-perceived quality of life, and health seeking behaviour. For women, questions about reproductive health and antenatal care, and for young children, vaccination coverage and achievement of child development goals, will also be assessed.

For physical examinations, tympanic temperature, weight and height will be measured in all household members, mid-upper arm circumference in young children, and blood pressure in adults. Blood sample will be collected from all participants aged 6 months and above. Venous blood samples will be collected from participants aged 5 years and older, and dried blood spot will be collected from children under 5 years. Samples will be shipped to a central laboratory and analysed. Haemoglobin PoC will be administered to all participants.

All data will be collected directly on an electronic case report form using tablets, and uploaded to an electronic database.

02

Conditions studied

  • Noncommunicable Disease
  • Infections
  • Risk Factors
  • Health Status

Keywords

  • Cross-sectional household survey
03

In context

Noncommunicable Diseases

144 studies on the registry are indexed under Noncommunicable Diseases; 55 are open to participants now.

This study's enrollment of 4,747 is above the median of 1,674 across 48 observational studies indexed under Noncommunicable Diseases.

Browse Noncommunicable Diseases studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Households located in the survey villages and identified in the household list are eligible for the survey. All members of the randomly selected households will be recruited

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All members of the selected households at the time of the survey; and able to provide .

Exclusion criteria

Exclusion Criteria:

  • Adults or children whose parent/guardian/ caretaker are unable or unwilling to provide .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
4,747 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • members of selected households at the time of survey

    371 households will be randomly selected from each site in Bangladesh, Cambodia, Myanmar, and Thailand. Assuming each household has an average of 4.5 members and all members will be sampled, 1500 participants will be recruited per site.

06

What researchers measure

Primary outcomes

  1. Prevalence of long-lasting antibodies (IgG) against selected causes of non-malaria febrile illnesses

    Time frame: Upon enrollment

  2. Prevalence of Plasmodium spp. by PCR

    Time frame: Upon enrollment

  3. Prevalence of chronic Hepatitis B and C

    Time frame: Upon enrollment

  4. Prevalence of selected non-communicable diseases (e.g. diabetes, chronic obstructive pulmonary diseases, stroke) according to self-reported disease history and laboratory tests

    Time frame: Upon enrollment

  5. Prevalence of reported disability

    Time frame: Upon enrollment

  6. Lifetime prevalence of reported injury or death caused by an accident

    Time frame: Upon enrollment

  7. Self-rated overall health status

    Time frame: Upon enrollment

  8. Questionnaire evaluation of health-related quality of life

    Time frame: Upon enrollment

  9. Prevalence of self-reported tobacco, alcohol, and other substitute use among the population aged 15 and above

    Time frame: Upon enrollment

  10. Prevalence of underweight and overweight, raised blood pressure and total cholesterol

    Time frame: Upon enrollment

Secondary outcomes

  1. Evaluation of household wealth quartile according to self-reported household characteristics

    Time frame: Upon enrollment

  2. Education level, marital status, and occupation

    Time frame: Upon enrollment

  3. Self-reported health-related household characteristics (e.g. household cooking fuel, source of drinking water, possession of mosquito net)

    Time frame: Upon enrollment

  4. Proportion of population self-reported having sought for medical care in the past month, and care providers visited

    Time frame: Upon enrollment

  5. Self-reported antenatal care coverage among women who have ever given birth

    Time frame: Upon enrollment

  6. Reported vaccination coverage among children < 3 years

    Time frame: Upon enrollment

  7. Prevalence of reported exclusive breast feeding among children < 5 years

    Time frame: Upon enrollment

  8. Prevalence of children aged 3-4 years who have reached early child development milestones, reported by caretaker

    Time frame: Upon enrollment

  9. Presence of self-reported symptoms or diagnosed illness besides the outcome measures of the primary objectives

    Time frame: Upon enrollment

  10. Reported illness in the last month and type of illness

    Time frame: Upon enrollment

  11. Prevalence of IgM antibodies against selected acute non-malaria causes of febrile illness

    Time frame: Upon enrollment

07

Study locations

4 sites
  • BangladeshBuilding Resources Across Communities (BRAC)
    Dhaka, 1212, Bangladesh
  • Cambodia Action for Health Development (AHEAD)
    Battambang, Cambodia
  • Medical Action Myanmar (MAM)
    Yangon, 11201, Myanmar
  • Chiangrai Clinical Research Unit (CCRU)
    Chiang Rai, 57000, Thailand
08

References and documents

Publications

  • Chandna A, Chew R, Shwe Nwe Htun N, Peto TJ, Zhang M, Liverani M, Brummaier T, Phommasone K, Perrone C, Pyae Phyo A, Sattabongkot J, Roobsoong W, Nguitragool W, Sen A, Ibna Zaman S, Sandar Zaw A, Batty E, Waithira N, Abdad MY, Blacksell SD, Bodhidatta L, Callery JJ, Fagnark W, Huangsuranun W, Islam S, Lertcharoenchoke S, Lohavittayavikant S, Mukaka M, Moul V, Kumer Neogi A, Nedsuwan S, Pongvongsa T, Ponsap P, Richard-Greenblatt M, Schilling WHK, Thaipadungpanit J, Tripura R, Dondorp AM, Mayxay M, White NJ, Nosten F, Smithuis F, Ashley EA, Maude RJ, Day NPJ, Lubell Y. Defining the burden of febrile illness in rural South and Southeast Asia: an open letter to announce the launch of the Rural Febrile Illness project. Wellcome Open Res. 2022 Mar 10;6:64. doi: 10.12688/wellcomeopenres.16393.2. eCollection 2021. PubMed 34017924 ↗

Related links

Individual participant data

Plan to share: Yes — With participant's consent, clinical data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future.

Time frame: After completion of survey activities and reporting

Access criteria: MORU Data Sharing Policy

Data sharing details ↗ · www.tropmedres.ac

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2022 to primary completion in Dec 2023, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2022
First posted
May 25, 2022
StartActual
Oct 3, 2022
Primary completionActual
Dec 10, 2023
CompletionActual
Dec 10, 2023
Last update
Feb 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05389540
Collaborators
Mahidol Oxford Tropical Medicine Research Unit, Chiang Rai Clinical Research Unit, Thailand, Myanmar Oxford Clinical Research Unit, Yangon, Myanmar, Bangladesh Rural Advancement Committee, Dhaka, Bangladesh, Cambodia Action for Health Development (AHEAD)
Responsible party
Sponsor
First posted
May 25, 2022
Start date
Oct 3, 2022
Primary completion
Dec 10, 2023
Completion
Dec 10, 2023
Last update
Feb 28, 2024

Study contacts

Yoel Lubell, Professor
principal investigator · Mahidol Oxford Tropical Medicine Research Unit
Thomas Peto, PhD
principal investigator · Mahidol Oxford Tropical Medicine Research Unit

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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