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AzTrials

Noncommunicable DiseaseSEACTN-HHSNCT05389540

Rural South and Southeast Asia Household Health Survey

An observational study of Noncommunicable Disease and Infections, run by University of Oxford at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Noncommunicable Disease, Infections, Risk Factors
How many people
4,747 participants
Where
4 sitesin 4 countries
Study dates
3 Oct 2022to 10 Dec 2023
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Adults or children whose parent/guardian/ caretaker are unable or unwilling to provide informed consent.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Bangladesh1 site

  • BangladeshBuilding Resources Across Communities (BRAC)

    Dhaka, 1212

Other trials in Bangladesh

Burma1 site

  • Medical Action Myanmar (MAM)

    Yangon, 11201

Other trials in Burma

Cambodia1 site

  • Cambodia Action for Health Development (AHEAD)

    Battambang

Other trials in Cambodia

Thailand1 site

  • Chiangrai Clinical Research Unit (CCRU)

    Chiang Rai, 57000

Other trials in Thailand

About this study

Official title: Overview of Disease Burden in Rural South and Southeast Asia: A Cross-sectional Household Health Survey With Questionnaire Interviews and Selected Laboratory Tests

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.

Keywords
Cross-sectional household survey
Medical subject headings
Noncommunicable Diseases, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05389540
Study groupRoleWhat they receive
members of selected households at the time of survey371 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Upon enrollment

  2. Prevalence of Plasmodium spp. by PCR

    Measured: Upon enrollment

  3. Prevalence of chronic Hepatitis B and C

    Measured: 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

    Measured: Upon enrollment

  5. Prevalence of reported disability

    Measured: Upon enrollment

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

    Measured: Upon enrollment

  7. Self-rated overall health status

    Measured: Upon enrollment

  8. Questionnaire evaluation of health-related quality of life

    Measured: Upon enrollment

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

    Measured: Upon enrollment

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

    Measured: Upon enrollment

Secondary outcomes (11)

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

    Measured: Upon enrollment

  2. Education level, marital status, and occupation

    Measured: Upon enrollment

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

    Measured: Upon enrollment

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

    Measured: Upon enrollment

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

    Measured: Upon enrollment

  6. Reported vaccination coverage among children < 3 years

    Measured: Upon enrollment

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

    Measured: Upon enrollment

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

    Measured: Upon enrollment

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

    Measured: Upon enrollment

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

    Measured: Upon enrollment

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

    Measured: Upon enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start3 Oct 2022
  3. Primary completion10 Dec 2023
  4. Study completion10 Dec 2023

Resources

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
Ecologic or community
Time perspective
Cross-sectional
Enrolment
4,747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05389540
Sponsor's protocol ID
HCR21013
Acronym
SEACTN-HHS
Status last verified
Feb 2024
First submitted
19 May 2022
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

  • Zhang M, Htun NSN, Islam S, Sen A, Islam A, Neogi AK, Tripura R, Dysoley L, Perrone C, Chew R, Batty EM, Thongpiam W, Wongsantichon J, Menggred C, Zaman SI, Waithira N, Blacksell S, Liverani M, Lee S, Maude RJ, Day NPJ, Lubell Y, Peto TJ. Defining the hidden burden of disease in rural communities in Bangladesh, Cambodia and Thailand: a cross-sectional household health survey protocol. BMJ Open. 2024 Mar 23;14(3):e081079. doi: 10.1136/bmjopen-2023-081079.

    PubMed 38521526

Questions about this trial

What is this clinical trial studying?

An observational study of Noncommunicable Disease and Infections, run by University of Oxford at 4 sites in 4 countries.

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 1 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Bangladesh, Burma, Cambodia, 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?

Prevalence of long-lasting antibodies (IgG) against selected causes of non-malaria febrile illnesses (time frame: Upon enrollment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05389540, which also lists 2 linked publications.

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 28 Feb 2024.

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