Rural South and Southeast Asia Household Health Survey

Infections Clinical Trial

— SEACTN-HHS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05389540
• Other study ID #: HCR21013
• Status: Completed
• Start date: October 3, 2022
• Est. completion date: December 10, 2023

Study information

• Verified date: February 2024
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4747
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Status
• Infections
• Noncommunicable Diseases
• Risk Factors

Locations

Country	Name	City	State
Bangladesh	BangladeshBuilding Resources Across Communities (BRAC)	Dhaka
Cambodia	Cambodia Action for Health Development (AHEAD)	Battambang
Myanmar	Medical Action Myanmar (MAM)	Yangon
Thailand	Chiangrai Clinical Research Unit (CCRU)	Chiang Rai

Sponsors (6)

Lead Sponsor	Collaborator
University of Oxford	Bangladesh Rural Advancement Committee, Dhaka, Bangladesh, Cambodia Action for Health Development (AHEAD), Chiang Rai Clinical Research Unit, Thailand, Mahidol Oxford Tropical Medicine Research Unit, Myanmar Oxford Clinical Research Unit, Yangon, Myanmar

Countries where clinical trial is conducted

Bangladesh,  Cambodia,  Myanmar,  Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of long-lasting antibodies (IgG) against selected causes of non-malaria febrile illnesses		Upon enrollment
Primary	Prevalence of Plasmodium spp. by PCR		Upon enrollment
Primary	Prevalence of chronic Hepatitis B and C		Upon enrollment
Primary	Prevalence of selected non-communicable diseases (e.g. diabetes, chronic obstructive pulmonary diseases, stroke) according to self-reported disease history and laboratory tests		Upon enrollment
Primary	Prevalence of reported disability		Upon enrollment
Primary	Lifetime prevalence of reported injury or death caused by an accident		Upon enrollment
Primary	Self-rated overall health status		Upon enrollment
Primary	Questionnaire evaluation of health-related quality of life		Upon enrollment
Primary	Prevalence of self-reported tobacco, alcohol, and other substitute use among the population aged 15 and above		Upon enrollment
Primary	Prevalence of underweight and overweight, raised blood pressure and total cholesterol		Upon enrollment
Secondary	Evaluation of household wealth quartile according to self-reported household characteristics		Upon enrollment
Secondary	Education level, marital status, and occupation		Upon enrollment
Secondary	Self-reported health-related household characteristics (e.g. household cooking fuel, source of drinking water, possession of mosquito net)		Upon enrollment
Secondary	Proportion of population self-reported having sought for medical care in the past month, and care providers visited		Upon enrollment
Secondary	Self-reported antenatal care coverage among women who have ever given birth		Upon enrollment
Secondary	Reported vaccination coverage among children < 3 years		Upon enrollment
Secondary	Prevalence of reported exclusive breast feeding among children < 5 years		Upon enrollment
Secondary	Prevalence of children aged 3-4 years who have reached early child development milestones, reported by caretaker		Upon enrollment
Secondary	Presence of self-reported symptoms or diagnosed illness besides the outcome measures of the primary objectives		Upon enrollment
Secondary	Reported illness in the last month and type of illness		Upon enrollment
Secondary	Prevalence of IgM antibodies against selected acute non-malaria causes of febrile illness		Upon enrollment

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