NCT05389540

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,747

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

May 19, 2022

Last Update Submit

February 27, 2024

Conditions

Keywords

Cross-sectional household survey

Outcome Measures

Primary Outcomes (10)

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

    Upon enrollment

  • Prevalence of Plasmodium spp. by PCR

    Upon enrollment

  • Prevalence of chronic Hepatitis B and C

    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

    Upon enrollment

  • Prevalence of reported disability

    Upon enrollment

  • Lifetime prevalence of reported injury or death caused by an accident

    Upon enrollment

  • Self-rated overall health status

    Upon enrollment

  • Questionnaire evaluation of health-related quality of life

    Upon enrollment

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

    Upon enrollment

  • Prevalence of underweight and overweight, raised blood pressure and total cholesterol

    Upon enrollment

Secondary Outcomes (11)

  • Evaluation of household wealth quartile according to self-reported household characteristics

    Upon enrollment

  • Education level, marital status, and occupation

    Upon enrollment

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

    Upon enrollment

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

    Upon enrollment

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

    Upon enrollment

  • +6 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

BangladeshBuilding Resources Across Communities (BRAC)

Dhaka, 1212, Bangladesh

Location

Medical Action Myanmar (MAM)

Yangon, 11201, Burma

Location

Cambodia Action for Health Development (AHEAD)

Battambang, Cambodia

Location

Chiangrai Clinical Research Unit (CCRU)

Chiang Rai, 57000, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 34017924BACKGROUND
  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples and Dried blood spot

MeSH Terms

Conditions

Noncommunicable DiseasesInfections

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yoel Lubell, Professor

    Mahidol Oxford Tropical Medicine Research Unit

    PRINCIPAL INVESTIGATOR
  • Thomas Peto, PhD

    Mahidol Oxford Tropical Medicine Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 25, 2022

Study Start

October 3, 2022

Primary Completion

December 10, 2023

Study Completion

December 10, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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.

Time Frame
After completion of survey activities and reporting
Access Criteria
MORU Data Sharing Policy
More information

Locations