Clinical trial NCT05389540: Rural South and Southeast Asia Household Health Survey
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noncommunicable Disease
Infections
Risk Factors
Health Status
Keywords: Cross-sectional household survey
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
name: Chiang Rai Clinical Research Unit, Thailand
name: Myanmar Oxford Clinical Research Unit, Yangon, Myanmar
name: Bangladesh Rural Advancement Committee, Dhaka, Bangladesh
name: Cambodia Action for Health Development (AHEAD)
First posted: 2022-05-25
Enrollment: 4747
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of long-lasting antibodies (IgG) against selected causes of non-malaria febrile illnesses
timeFrame: Upon enrollment
measure: Prevalence of Plasmodium spp. by PCR
timeFrame: Upon enrollment
measure: Prevalence of chronic Hepatitis B and C
timeFrame: Upon enrollment
measure: Prevalence of selected non-communicable diseases (e.g. diabetes, chronic obstructive pulmonary diseases, stroke) according to self-reported disease history and laboratory tests
timeFrame: Upon enrollment
measure: Prevalence of reported disability
timeFrame: Upon enrollment
measure: Lifetime prevalence of reported injury or death caused by an accident
timeFrame: Upon enrollment
measure: Self-rated overall health status
timeFrame: Upon enrollment
measure: Questionnaire evaluation of health-related quality of life
timeFrame: Upon enrollment
measure: Prevalence of self-reported tobacco, alcohol, and other substitute use among the population aged 15 and above
timeFrame: Upon enrollment
measure: Prevalence of underweight and overweight, raised blood pressure and total cholesterol
timeFrame: Upon enrollment
Secondary outcomes:
measure: Evaluation of household wealth quartile according to self-reported household characteristics
timeFrame: Upon enrollment
measure: Education level, marital status, and occupation
timeFrame: Upon enrollment
measure: Self-reported health-related household characteristics (e.g. household cooking fuel, source of drinking water, possession of mosquito net)
timeFrame: Upon enrollment
measure: Proportion of population self-reported having sought for medical care in the past month, and care providers visited
timeFrame: Upon enrollment
measure: Self-reported antenatal care coverage among women who have ever given birth
timeFrame: Upon enrollment
measure: Reported vaccination coverage among children < 3 years
timeFrame: Upon enrollment
measure: Prevalence of reported exclusive breast feeding among children < 5 years
timeFrame: Upon enrollment
measure: Prevalence of children aged 3-4 years who have reached early child development milestones, reported by caretaker
timeFrame: Upon enrollment
measure: Presence of self-reported symptoms or diagnosed illness besides the outcome measures of the primary objectives
timeFrame: Upon enrollment
measure: Reported illness in the last month and type of illness
timeFrame: Upon enrollment
measure: Prevalence of IgM antibodies against selected acute non-malaria causes of febrile illness
timeFrame: Upon enrollment
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BangladeshBuilding Resources Across Communities (BRAC)
city: Battambang
country: Cambodia
facility: Cambodia Action for Health Development (AHEAD)
city: Yangon
country: Myanmar
facility: Medical Action Myanmar (MAM)
city: Chiang Rai
country: Thailand
facility: Chiangrai Clinical Research Unit (CCRU)
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Yoel Lubell, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Thomas Peto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.