Rural South and Southeast Asia Household Health Survey (SEACTN-HHS)

February 27, 2024 updated by: University of Oxford

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

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

Observational

Enrollment (Actual)

4747

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of long-lasting antibodies (IgG) against selected causes of non-malaria febrile illnesses
Time Frame: Upon enrollment
Upon enrollment
Prevalence of Plasmodium spp. by PCR
Time Frame: Upon enrollment
Upon enrollment
Prevalence of chronic Hepatitis B and C
Time Frame: Upon enrollment
Upon enrollment
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
Upon enrollment
Prevalence of reported disability
Time Frame: Upon enrollment
Upon enrollment
Lifetime prevalence of reported injury or death caused by an accident
Time Frame: Upon enrollment
Upon enrollment
Self-rated overall health status
Time Frame: Upon enrollment
Upon enrollment
Questionnaire evaluation of health-related quality of life
Time Frame: Upon enrollment
Upon enrollment
Prevalence of self-reported tobacco, alcohol, and other substitute use among the population aged 15 and above
Time Frame: Upon enrollment
Upon enrollment
Prevalence of underweight and overweight, raised blood pressure and total cholesterol
Time Frame: Upon enrollment
Upon enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of household wealth quartile according to self-reported household characteristics
Time Frame: Upon enrollment
Upon enrollment
Education level, marital status, and occupation
Time Frame: Upon enrollment
Upon enrollment
Self-reported health-related household characteristics (e.g. household cooking fuel, source of drinking water, possession of mosquito net)
Time Frame: Upon enrollment
Upon enrollment
Proportion of population self-reported having sought for medical care in the past month, and care providers visited
Time Frame: Upon enrollment
Upon enrollment
Self-reported antenatal care coverage among women who have ever given birth
Time Frame: Upon enrollment
Upon enrollment
Reported vaccination coverage among children < 3 years
Time Frame: Upon enrollment
Upon enrollment
Prevalence of reported exclusive breast feeding among children < 5 years
Time Frame: Upon enrollment
Upon enrollment
Prevalence of children aged 3-4 years who have reached early child development milestones, reported by caretaker
Time Frame: Upon enrollment
Upon enrollment
Presence of self-reported symptoms or diagnosed illness besides the outcome measures of the primary objectives
Time Frame: Upon enrollment
Upon enrollment
Reported illness in the last month and type of illness
Time Frame: Upon enrollment
Upon enrollment
Prevalence of IgM antibodies against selected acute non-malaria causes of febrile illness
Time Frame: Upon enrollment
Upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HCR21013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After completion of survey activities and reporting

IPD Sharing Access Criteria

MORU Data Sharing Policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Infections

3
Subscribe