- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389540
Rural South and Southeast Asia Household Health Survey (SEACTN-HHS)
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
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Yoel Lubell, Professor
- Phone Number: +66-857201350
- Email: Yoel@tropmedres.ac
Study Contact Backup
- Name: Meiwen Zhang, Dr.
- Email: Meiwen@tropmedres.ac
Study Locations
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Dhaka, Bangladesh, 1212
- BangladeshBuilding Resources Across Communities (BRAC)
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Battambang, Cambodia
- Cambodia Action for Health Development (AHEAD)
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Yangon, Myanmar, 11201
- Medical Action Myanmar (MAM)
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Chiang Rai, Thailand, 57000
- Chiangrai Clinical Research Unit (CCRU)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All members of the selected households at the time of the survey; and able to provide informed consent.
Exclusion Criteria:
- Adults or children whose parent/guardian/ caretaker are unable or unwilling to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Prevalence of long-lasting antibodies (IgG) against selected causes of non-malaria febrile illnesses
Time Frame: Upon enrollment
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Upon enrollment
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Prevalence of Plasmodium spp. by PCR
Time Frame: Upon enrollment
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Upon enrollment
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Prevalence of chronic Hepatitis B and C
Time Frame: Upon enrollment
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Upon enrollment
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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
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Upon enrollment
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Prevalence of reported disability
Time Frame: Upon enrollment
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Upon enrollment
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Lifetime prevalence of reported injury or death caused by an accident
Time Frame: Upon enrollment
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Upon enrollment
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Self-rated overall health status
Time Frame: Upon enrollment
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Upon enrollment
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Questionnaire evaluation of health-related quality of life
Time Frame: Upon enrollment
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Upon enrollment
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Prevalence of self-reported tobacco, alcohol, and other substitute use among the population aged 15 and above
Time Frame: Upon enrollment
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Upon enrollment
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Prevalence of underweight and overweight, raised blood pressure and total cholesterol
Time Frame: Upon enrollment
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Upon enrollment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluation of household wealth quartile according to self-reported household characteristics
Time Frame: Upon enrollment
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Upon enrollment
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Education level, marital status, and occupation
Time Frame: Upon enrollment
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Upon enrollment
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Self-reported health-related household characteristics (e.g. household cooking fuel, source of drinking water, possession of mosquito net)
Time Frame: Upon enrollment
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Upon enrollment
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Proportion of population self-reported having sought for medical care in the past month, and care providers visited
Time Frame: Upon enrollment
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Upon enrollment
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Self-reported antenatal care coverage among women who have ever given birth
Time Frame: Upon enrollment
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Upon enrollment
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Reported vaccination coverage among children < 3 years
Time Frame: Upon enrollment
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Upon enrollment
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Prevalence of reported exclusive breast feeding among children < 5 years
Time Frame: Upon enrollment
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Upon enrollment
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Prevalence of children aged 3-4 years who have reached early child development milestones, reported by caretaker
Time Frame: Upon enrollment
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Upon enrollment
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Presence of self-reported symptoms or diagnosed illness besides the outcome measures of the primary objectives
Time Frame: Upon enrollment
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Upon enrollment
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Reported illness in the last month and type of illness
Time Frame: Upon enrollment
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Upon enrollment
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Prevalence of IgM antibodies against selected acute non-malaria causes of febrile illness
Time Frame: Upon enrollment
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Upon enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yoel Lubell, Professor, Mahidol Oxford Tropical Medicine Research Unit
- Principal Investigator: Thomas Peto, PhD, Mahidol Oxford Tropical Medicine Research Unit
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCR21013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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