NCT02396407

Brief Summary

The purpose of this study is to measure whether a combined water, sanitation, and hygiene intervention leads to improved health of children who did not receive the intervention themselves and who live within a close vicinity of intervention recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,789

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 18, 2015

Last Update Submit

October 25, 2016

Conditions

Keywords

Chlorine water treatmentPoint-of-use water treatmentHousehold water treatment with safe storageHandwashing with soapHand hygieneLatrinesChild pottiesIntestinal parasitic infectionSoil-transmitted helminthsWaterSanitationHandwashingDiarrheaHerd immunityHelminths

Outcome Measures

Primary Outcomes (2)

  • Prevalence of soil-transmitted helminths (Ascaris, hookworm, Trichuris)

    Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Stool samples with any ova will be considered positive.

    Measured approximately 24 months after intervention

  • Intensity of soil-transmitted helminth infections (Ascaris, hookworm, Trichuris)

    Children's stool will be collected. Kato-Katz will be used to detect Ascaris, hookworm, Trichuris ova in stool. Intensity will be measured using WHO cutoffs based on the number of eggs per gram of stool (\>=5,000 eggs/gram for Ascaris, \>=1,000 eggs/gram for hookworm, and \>=2,000 eggs/gram for Trichuris).

    Measured approximately 24 months after intervention

Secondary Outcomes (2)

  • Diarrhea prevalence

    Measured approximately 24 months after intervention

  • Respiratory illness prevalence

    Measured approximately 24 months after intervention

Study Arms (2)

Combined water, sanitation, and hygiene

ACTIVE COMPARATOR

Water quality, Sanitation, Handwashing

Behavioral: Combined water, sanitation, and hygiene

Non-intervention arm

NO INTERVENTION

None. Households will continue their usual practices.

Interventions

Water: Free chlorine tablets (Aquatabs; NaDCC) and safe storage vessel to treat and store drinking water. Sanitation: Free child potties, sani-scoop hoes to remove feces from household, and latrine upgrades to a dual pit latrine for all households in study compounds. Handwashing: Handwashing stations including soapy water bottles and detergent soap. Local promoters visit study compounds at least monthly to deliver behavior change messages that focus on (1) treating drinking water for children \< 36 months of age, (2) use of latrines for defecation and the removal of human and animal feces from the compound, and (3) handwashing with soap at critical times around food preparation, defecation, and contact with feces.

Combined water, sanitation, and hygiene

Eligibility Criteria

AgeUp to 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children not enrolled in WASH Benefits who live in a compound within 120 steps (2 minutes walking time) of a compound enrolled in WASH Benefits (combined WSH or control arms) and are 0-60 months 24 months after intervention

You may not qualify if:

  • Children enrolled in WASH Benefits
  • Children who live in compounds (baris) that share a courtyard with a compound enrolled in the WASH Benefits study
  • Children who live in compounds (baris) that share a latrine or handwashing station with a compound enrolled in the WASH Benefits study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (7)

  • Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476.

    PMID: 23996605BACKGROUND
  • Lin A, Arnold BF, Afreen S, Goto R, Huda TMN, Haque R, Raqib R, Unicomb L, Ahmed T, Colford JM, Luby SP. Household environmental conditions are associated with enteropathy and impaired growth in rural Bangladesh. Am J Trop Med Hyg. 2013 Jul;89(1):130-137. doi: 10.4269/ajtmh.12-0629. Epub 2013 Apr 29.

    PMID: 23629931BACKGROUND
  • Sultana R, Mondal UK, Rimi NA, Unicomb L, Winch PJ, Nahar N, Luby SP. An improved tool for household faeces management in rural Bangladeshi communities. Trop Med Int Health. 2013 Jul;18(7):854-60. doi: 10.1111/tmi.12103. Epub 2013 Apr 5.

    PMID: 23557125BACKGROUND
  • Hulland KR, Leontsini E, Dreibelbis R, Unicomb L, Afroz A, Dutta NC, Nizame FA, Luby SP, Ram PK, Winch PJ. Designing a handwashing station for infrastructure-restricted communities in Bangladesh using the integrated behavioural model for water, sanitation and hygiene interventions (IBM-WASH). BMC Public Health. 2013 Sep 23;13:877. doi: 10.1186/1471-2458-13-877.

    PMID: 24060247BACKGROUND
  • Dreibelbis R, Winch PJ, Leontsini E, Hulland KR, Ram PK, Unicomb L, Luby SP. The Integrated Behavioural Model for Water, Sanitation, and Hygiene: a systematic review of behavioural models and a framework for designing and evaluating behaviour change interventions in infrastructure-restricted settings. BMC Public Health. 2013 Oct 26;13:1015. doi: 10.1186/1471-2458-13-1015.

    PMID: 24160869BACKGROUND
  • Vujcic J, Ram PK, Hussain F, Unicomb L, Gope PS, Abedin J, Mahmud ZH, Islam MS, Luby SP. Toys and toilets: cross-sectional study using children's toys to evaluate environmental faecal contamination in rural Bangladeshi households with different sanitation facilities and practices. Trop Med Int Health. 2014 May;19(5):528-36. doi: 10.1111/tmi.12292. Epub 2014 Mar 19.

    PMID: 24645919BACKGROUND
  • Ercumen A, Naser AM, Unicomb L, Arnold BF, Colford JM Jr, Luby SP. Effects of source- versus household contamination of tubewell water on child diarrhea in rural Bangladesh: a randomized controlled trial. PLoS One. 2015 Mar 27;10(3):e0121907. doi: 10.1371/journal.pone.0121907. eCollection 2015.

    PMID: 25816342BACKGROUND

Related Links

MeSH Terms

Conditions

HelminthiasisDiarrheaRespiratory Tract InfectionsIntestinal Diseases, Parasitic

Interventions

SanitationHygiene

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Communicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public HealthTherapeutics

Study Officials

  • John M Colford, Jr., MD PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 24, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations